The peer review process for the evaluation of
manuscripts for publication needs to be better understood by the
orthopaedic community. Improving the degree of transparency surrounding
the review process and educating orthopaedic surgeons on how to
improve their manuscripts for submission will help improve both
the review procedure and resultant feedback, with an increase in
the quality of the subsequent publications. This article seeks to clarify
the peer review process and suggest simple ways in which the quality
of submissions can be improved to maximise publication success. Cite this article:
Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization. A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014).Aims
Methods
During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group.Aims
Methods
The gold standard for percutaneous Achilles tendon tenotomy during the Ponseti treatment for idiopathic clubfoot is a tenotomy with a No. 15 blade. This trial aims to establish the technique where the tenotomy is performed with a large-bore needle as noninferior to the gold standard. We randomized feet from children aged below 36 months with idiopathic clubfoot on a 1:1 basis in either the blade or needle group. Follow-up was conducted at three weeks and three months postoperatively, where dorsiflexion range, Pirani scores, and complications were recorded. The noninferiority margin was set at 4° difference in dorsiflexion range at three months postoperatively.Aims
Methods
Hip fractures are a major cause of morbidity and mortality, and malnutrition is a crucial determinant of these outcomes. This meta-analysis aims to determine whether oral nutritional supplementation (ONS) improves postoperative outcomes in older patients with a hip fracture. A systematic literature search was conducted in August 2022. ONS was defined as high protein-based diet strategies containing (or not containing) carbohydrates, fat, vitamins, and minerals. Randomized trials documenting ONS in older patients with hip fracture (aged ≥ 50 years) were included. Two reviewers evaluated study eligibility, conducted data extraction, and assessed study quality.Aims
Methods
The efficacy of saline irrigation for treatment of implant-associated infections is limited in the presence of porous metallic implants. This study evaluated the therapeutic efficacy of antibiotic doped bioceramic (vancomycin/tobramycin-doped polyvinyl alcohol composite (PVA-VAN/TOB-P)) after saline wash in a mouse infection model implanted with titanium cylinders. Air pouches created in female BalBc mice by subcutaneous injection of air. In the first of two independent studies, pouches were implanted with titanium cylinders (400, 700, and 100 µm pore sizes) and inoculated with Aims
Methods
Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies. Cite this article:
The primary aim of this study is to quantify and compare outcomes following a dorsally displaced fracture of the distal radius in elderly patients (aged ≥ 65 years) who are managed conservatively versus with surgical fixation (open reduction and internal fixation). Secondary aims are to assess and compare upper limb-specific function, health-related quality of life, wrist pain, complications, grip strength, range of motion, radiological parameters, healthcare resource use, and cost-effectiveness between the groups. A prospectively registered (ISRCTN95922938) randomized parallel group trial will be conducted. Elderly patients meeting the inclusion criteria with a dorsally displaced distal radius facture will be randomized (1:1 ratio) to either conservative management (cast without further manipulation) or surgery. Patients will be assessed at six, 12, 26 weeks, and 52 weeks post intervention. The primary outcome measure and endpoint will be the Patient-Rated Wrist Evaluation (PRWE) at 52 weeks. In addition, the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH), EuroQol five-dimension questionnaire, pain score (visual analogue scale 1 to 10), complications, grip strength (dynamometer), range of motion (goniometer), and radiological assessments will be undertaken. A cost-utility analysis will be performed to assess the cost-effectiveness of surgery. We aim to recruit 89 subjects per arm (total sample size 178).Aims
Methods
Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.Aims
Methods
Closed suction subfascial drainage is widely used after instrumented posterior spinal fusion in patients with a spinal deformity. The aim of this study was to determine the effect of this wound drainage on the outcomes in patients with adolescent idiopathic scoliosis (AIS). This was a further analysis of a randomized, multicentre clinical trial reporting on patients after posterior spinal fusion using segmental pedicle screw instrumentation. In this study the incidence of deep surgical site infection (SSI) and chronic postoperative pain at two years’ follow-up are reported. We conducted a randomized, multicentre clinical trial on adolescents undergoing posterior spinal fusion for AIS using segmental pedicle screw instrumentation. A total of 90 consecutive patients were randomized into a ‘drain’ or ‘no drain’ group at the time of wound closure, using the sealed envelope technique (1:1). The primary outcomes in the initial study were the change in the level of haemoglobin in the blood postoperatively and total blood loss. A secondary outcome was the opioid consumption immediately after surgery. The aim of this further study was to report the rate of deep SSI and persistent postoperative pain, at two years' follow-up.Aims
Methods
Steroid injections are used for subacromial pain syndrome and can be administered via the anterolateral or posterior approach to the subacromial space. It is not currently known which approach is superior in terms of improving clinical symptoms and function. This is the protocol for a randomized controlled trial (RCT) to compare the clinical effectiveness of a steroid injection given via the anterolateral or the posterior approach to the subacromial space. The Subacromial Approach Injection Trial (SAInT) study is a single-centre, parallel, two-arm RCT. Participants will be allocated on a 1:1 basis to a subacromial steroid injection via either the anterolateral or the posterior approach to the subacromial space. Participants in both trial arms will then receive physiotherapy as standard of care for subacromial pain syndrome. The primary analysis will compare the change in Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include the change in OSS at six and 12 months, as well as the Pain Numeric Rating Scale (0 = no pain, 10 = worst pain), Disabilities of Arm, Shoulder and Hand questionnaire (DASH), and 36-Item Short-Form Health Survey (SF-36) (RAND) at three months, six months, and one year after injection. Assessment of pain experienced during the injection will also be determined. A minimum of 86 patients will be recruited to obtain an 80% power to detect a minimally important difference of six points on the OSS change between the groups at three months after injection.Aims
Methods
The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy. Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions.Aims
Methods
Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury.Aims
Methods
Although low-intensity pulsed ultrasound (LIPUS) combined with disinfectants has been shown to effectively eliminate portions of biofilm in vitro, its efficacy in vivo remains uncertain. Our objective was to assess the antibiofilm potential and safety of LIPUS combined with 0.35% povidone-iodine (PI) in a rat debridement, antibiotics, and implant retention (DAIR) model of periprosthetic joint infection (PJI). A total of 56 male Sprague-Dawley rats were established in acute PJI models by intra-articular injection of bacteria. The rats were divided into four groups: a Control group, a 0.35% PI group, a LIPUS and saline group, and a LIPUS and 0.35% PI group. All rats underwent DAIR, except for Control, which underwent a sham procedure. General status, serum biochemical markers, weightbearing analysis, radiographs, micro-CT analysis, scanning electron microscopy of the prostheses, microbiological analysis, macroscope, and histopathology evaluation were performed 14 days after DAIR.Aims
Methods
This study investigated the effects of transcatheter arterial embolization (TAE) on pain, function, and quality of life in people with early-stage symptomatic knee osteoarthritis (OA) compared to a sham procedure. A total of 59 participants with symptomatic Kellgren-Lawrence grade 2 knee OA were randomly allocated to TAE or a sham procedure. The intervention group underwent TAE of one or more genicular arteries. The control group received a blinded sham procedure. The primary outcome was knee pain at 12 months according to the Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale. Secondary outcomes included self-reported function and quality of life (KOOS, EuroQol five-dimension five-level questionnaire (EQ-5D-5L)), self-reported Global Change, six-minute walk test, 30-second chair stand test, and adverse events. Subgroup analyses compared participants who received complete embolization of all genicular arteries (as distinct from embolization of some arteries) (n = 17) with the control group (n = 29) for KOOS and Global Change scores at 12 months. Continuous variables were analyzed with quantile regression, adjusting for baseline scores. Dichotomized variables were analyzed with chi-squared tests.Aims
Methods
The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children’s Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children’s Elbows (SCIENCE) trial. Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment.Aims
Methods
Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon. SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments.Aims
Methods
Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.Aims
Methods
Osteoporosis is characterized by decreased trabecular bone volume, and microarchitectural deterioration in the medullary cavity. Blood and femoral bone marrow suspension Aims
Methods
Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures. This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.Aims
Methods
To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.Aims
Methods
Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care. This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment.Aims
Methods
The aim of this study was to evaluate whether, after correction of an adolescent idiopathic scoliosis (AIS), leaving out the subfascial drain gives results that are no worse than using a drain in terms of total blood loss, drop in haemoglobin level, and opioid consumption. Adolescents (aged between 10 and 21 years) with an idiopathic scoliosis (major curve ≥ 45°) were eligible for inclusion in this randomized controlled noninferiority trial (n = 125). A total of 90 adolescents who had undergone segmental pedicle screw instrumentation were randomized into no-drain or drain groups at the time of wound closure using the sealed envelope technique (1:1). The primary outcome was a drop in the haemoglobin level during first three postoperative days. Secondary outcomes were 48-hour postoperative oxycodone consumption and surgical complications.Aims
Methods
Although absorbable sutures for the repair of acute Achilles tendon rupture (ATR) have been attracting attention, the rationale for their use remains insufficient. This study prospectively compared the outcomes of absorbable and nonabsorbable sutures for the repair of acute ATR. A total of 40 patients were randomly assigned to either braided absorbable polyglactin suture or braided nonabsorbable polyethylene terephthalate suture groups. ATR was then repaired using the Krackow suture method. At three and six months after surgery, the isokinetic muscle strength of ankle plantar flexion was measured using a computer-based Cybex dynamometer. At six and 12 months after surgery, patient-reported outcomes were measured using the Achilles tendon Total Rupture Score (ATRS), visual analogue scale for pain (VAS pain), and EuroQoL five-dimension health questionnaire (EQ-5D).Aims
Methods
To evaluate inducing osteoarthritis (OA) by surgical destabilization of the medial meniscus (DMM) in mice with and without a stereomicroscope. Based on sample size calculation, 70 male C57BL/6 mice were randomly assigned to three surgery groups: DMM aided by a stereomicroscope; DMM by naked eye; or sham surgery. The group information was blinded to researchers. Mice underwent static weightbearing, von Frey test, and gait analysis at two-week intervals from eight to 16 weeks after surgery. Histological grade of OA was determined with the Osteoarthritis Research Society International (OARSI) scoring system.Aims
Methods
Hand trauma accounts for one in five of emergency department attendances, with a UK incidence of over five million injuries/year and 250,000 operations/year. Surgical site infection (SSI) in hand trauma surgery leads to further interventions, poor outcomes, and prolonged recovery, but has been poorly researched. Antimicrobial sutures have been recognized by both the World Health Organization and the National Institute for Clinical Excellence as potentially effective for reducing SSI. They have never been studied in hand trauma surgery: a completely different patient group and clinical pathway to previous randomized clinical trials (RCTs) of these sutures. Antimicrobial sutures are expensive, and further research in hand trauma is warranted before they become standard of care. The aim of this protocol is to conduct a feasibility study of antimicrobial sutures in patients undergoing hand trauma surgery to establish acceptability, compliance, and retention for a definitive trial. A two-arm, multicentre feasibility RCT of 116 adult participants with hand and wrist injuries, randomized to either antimicrobial sutures or standard sutures. Study participants and outcome assessors will be blinded to treatment allocation. Outcome measures will be recorded at baseline (preoperatively), 30 days, 90 days, and six months, and will include SSI, patient-reported outcome measures, and return to work.Aims
Methods
Nearly 99,000 total knee arthroplasties (TKAs) are performed in UK annually. Despite plenty of research, the satisfaction rate of this surgery is around 80%. One of the important intraoperative factors affecting the outcome is alignment. The relationship between joint obliquity and functional outcomes is not well understood. Therefore, a study is required to investigate and compare the effects of two types of alignment (mechanical and kinematic) on functional outcomes and range of motion. The aim of the study is to compare navigated kinematically aligned TKAs (KA TKAs) with navigated mechanically aligned TKA (MA TKA) in terms of function and ROM. We aim to recruit a total of 96 patients in the trial. The patients will be recruited from clinics of various consultants working in the trust after screening them for eligibility criteria and obtaining their informed consent to participate in this study. Randomization will be done prior to surgery by a software. The primary outcome measure will be the Knee injury and Osteoarthritis Outcome Score The secondary outcome measures include Oxford Knee Score, ROM, EuroQol five-dimension questionnaire, EuroQol visual analogue scale, 12-Item Short-Form Health Survey (SF-12), and Forgotten Joint Score. The scores will be calculated preoperatively and then at six weeks, six months, and one year after surgery. The scores will undergo a statistical analysis.Aims
Methods
Complex joint fractures of the lower extremity are often accompanied by soft-tissue swelling and are associated with prolonged hospitalization and soft-tissue complications. The aim of the study was to evaluate the effect of vascular impulse technology (VIT) on soft-tissue conditioning in comparison with conventional elevation. A total of 100 patients were included in this prospective, randomized, controlled monocentre study allocated to the three subgroups of dislocated ankle fracture (n = 40), pilon fracture (n = 20), and intra-articular calcaneal fracture (n = 40). Patients were randomized to the two study groups in a 1:1 ratio. The effectiveness of VIT (intervention) compared with elevation (control) was analyzed separately for the whole study population and for the three subgroups. The primary endpoint was the time from admission until operability (in days).Aims
Methods
Ideal component sizing may be difficult to achieve in unicompartmental knee arthroplasty (UKA). Anatomical variants, incremental implant size, and a reduced surgical exposure may lead to over- or under-sizing of the components. The purpose of this study was to compare the accuracy of UKA sizing with robotic-assisted techniques versus a conventional surgical technique. Three groups of 93 medial UKAs were assessed. The first group was performed by a conventional technique, the second group with an image-free robotic-assisted system (Image-Free group), and the last group with an image-based robotic arm-assisted system, using a preoperative CT scan (Image-Based group). There were no demographic differences between groups. We compared six parameters on postoperative radiographs to assess UKA sizing. Incorrect sizing was defined by an over- or under-sizing greater than 3 mm.Aims
Methods
Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group.Aims
Methods
This study aimed to compare the effect of antibiotic-loaded bone cement (ALBC) versus plain bone cement (PBC) on revision rates for periprosthetic joint infection (PJI) and all-cause revisions following primary elective total hip arthroplasty (THA) and total knee arthroplasty (TKA). MEDLINE, Embase, Web of Science, and Cochrane databases were systematically searched for studies comparing ALBC versus PBC, reporting on revision rates for PJI or all-cause revision following primary elective THA or TKA. A random-effects meta-analysis was performed. The study was registered in the International Prospective Register of Systematic Reviews (PROSPERO ID CRD42018107691).Aims
Methods
Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures.Aims
Methods
Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre.Aims
Methods
Irrigation is the cornerstone of treating skeletal infection by eliminating pathogens in wounds. A previous study shows that irrigation with normal saline (0.9%) and ethylenediaminetetraacetic acid (EDTA) could improve the removal of We established three wound infection models (skin defect, bone-exposed, implant-exposed) by inoculating the wounds with a variety of representative drug-resistant bacteria including methicillin-resistant Objectives
Methods
Dupuytren’s contracture is a benign, myoproliferative condition
affecting the palmar fascia that results in progressive contractures
of the fingers. Despite increased knowledge of the cellular and
connective tissue changes involved, neither a cure nor an optimum
form of treatment exists. The aim of this systematic review was
to summarize the best available evidence on the management of this
condition. A comprehensive database search for randomized controlled trials
(RCTs) was performed until August 2017. We studied RCTs comparing
open fasciectomy with percutaneous needle aponeurotomy (PNA), collagenase
clostridium histolyticum (CCH) with placebo, and CCH with PNA, in
addition to adjuvant treatments aiming to improve the outcome of
open fasciectomy. A total of 20 studies, involving 1584 patients,
were included.Aims
Materials and Methods
The aim of this study was to determine how the short- and medium-
to long-term outcome measures after total disc replacement (TDR)
compare with those of anterior cervical discectomy and fusion (ACDF),
using a systematic review and meta-analysis. Databases including Medline, Embase, and Scopus were searched.
Inclusion criteria involved prospective randomized control trials
(RCTs) reporting the surgical treatment of patients with symptomatic
degenerative cervical disc disease. Two independent investigators
extracted the data. The strength of evidence was assessed using
the Grading of Recommendations, Assessment, Development and Evaluation
(GRADE) criteria. The primary outcome measures were overall and
neurological success, and these were included in the meta-analysis. Standardized
patient-reported outcomes, including the incidence of further surgery
and adjacent segment disease, were summarized and discussed.Aims
Patients and Methods
This study aimed to compare the change in health-related quality
of life of patients receiving a traditional cemented monoblock Thompson
hemiarthroplasty compared with a modern cemented modular polished-taper
stemmed hemiarthroplasty for displaced intracapsular hip fractures. This was a pragmatic, multicentre, multisurgeon, two-arm, parallel
group, randomized standard-of-care controlled trial. It was embedded
within the WHiTE Comprehensive Cohort Study. The sample size was
964 patients. The setting was five National Health Service Trauma
Hospitals in England. A total of 964 patients over 60 years of age who
required hemiarthroplasty of the hip between February 2015 and March
2016 were included. A standardized measure of health outcome, the
EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and
at four months following the operation.Aims
Patients and Methods
Flail chest from a blunt injury to the thorax is associated with
significant morbidity and mortality. Its management globally is
predominantly non-operative; however, there are an increasing number
of centres which undertake surgical stabilisation. The aim of this
meta-analysis was to compare the efficacy of this approach with
that of non-operative management. A systematic search of the literature was carried out to identify
randomised controlled trials (RCTs) which compared the clinical
outcome of patients with a traumatic flail chest treated by surgical
stabilisation of any kind with that of non-operative management.Aims
Patients and Methods
Our aim was to determine whether, based on the current literature,
bariatric surgery prior to total hip (THA) or total knee arthroplasty
(TKA) reduces the complication rates and improves the outcome following
arthroplasty in obese patients. A systematic literature search was undertaken of published and
unpublished databases on the 5 November 2015. All papers reporting
studies comparing obese patients who had undergone bariatric surgery
prior to arthroplasty, or not, were included. Each study was assessed
using the Downs and Black appraisal tool. A meta-analysis of risk ratios
(RR) and 95% confidence intervals (CI) was performed to determine
the incidence of complications including wound infection, deep vein
thrombosis (DVT), pulmonary embolism (PE), revision surgery and
mortality.Aims
Methods
Our aim was to perform a systematic review of the literature
to assess the incidence of post-operative epidural haematomas and
wound infections after one-, or two-level, non-complex, lumbar surgery
for degenerative disease in patients with, or without post-operative
wound drainage. Studies were identified from PubMed and EMBASE, up to and including
27 August 2015, for papers describing one- or two-level lumbar discectomy
and/or laminectomy for degenerative disease in adults which reported
any form of subcutaneous or subfascial drainage.Aims
Patients and Methods
We performed a systematic review of the literature to determine the safety and efficacy of bone morphogenetic protein (BMP) compared with bone graft when used specifically for revision spinal fusion surgery secondary to pseudarthrosis. The MEDLINE, EMBASE and Cochrane Library databases were searched using defined search terms. The primary outcome measure was spinal fusion, assessed as success or failure in accordance with radiograph, MRI or CT scan review at 24-month follow-up. The secondary outcome measure was time to fusion.Objectives
Methods
Osteoporosis has become an increasing concern for older people as it may potentially lead to osteoporotic fractures. This study is designed to assess the efficacy and safety of ten therapies for post-menopausal women using network meta-analysis. We conducted a systematic search in several databases, including PubMed and Embase. A random-effects model was employed and results were assessed by the odds ratio (OR) and corresponding 95% confidence intervals (CI). Furthermore, with respect to each outcome, each intervention was ranked according to the surface under the cumulative ranking curve (SUCRA) value.Objectives
Methods
We performed a systematic review and meta-analysis
of modern total ankle replacements (TARs) to determine the survivorship,
outcome, complications, radiological findings and range of movement,
in patients with end-stage osteoarthritis (OA) of the ankle who
undergo this procedure. We used the methodology of the Cochrane Collaboration,
which uses risk of bias profiling to assess the quality of papers
in favour of a domain-based approach. Continuous outcome scores
were pooled across studies using the generic inverse variance method
and the random-effects model was used to incorporate clinical and
methodological heterogeneity. We included 58 papers (7942 TARs)
with an interobserver reliability (Kappa) for selection, performance,
attrition, detection and reporting bias of between 0.83 and 0.98.
The overall survivorship was 89% at ten years with an annual failure
rate of 1.2% (95% confidence interval (CI) 0.7 to 1.6). The mean
American Orthopaedic Foot and Ankle Society score changed from 40 (95%
CI 36 to 43) pre-operatively to 80 (95% CI 76 to 84) at a mean follow-up
of 8.2 years (7 to 10) (p <
0.01). Radiolucencies were identified
in up to 23% of TARs after a mean of 4.4 years (2.3 to 9.6). The
mean total range of movement improved from 23° (95% CI 19 to 26)
to 34° (95% CI 26 to 41) (p = 0.01). Our study demonstrates that TAR has a positive impact on patients’
lives, with benefits lasting ten years, as judged by improvement
in pain and function, as well as improved gait and increased range
of movement. However, the quality of evidence is weak and fraught
with biases and high quality randomised controlled trials are required
to compare TAR with other forms of treatment such as fusion. Cite this article:
Our purpose was to determine the quality of current randomised
controlled trials (RCTs) in hand surgery using standardised metrics. Based on five-year mean impact factors, we selected the six journals
that routinely publish studies of upper extremity surgery. Using
a journal-specific search query, 62 RCTs met our inclusion criteria.
Then three blinded reviewers used the Jadad and revised Coleman Methodology
Score (RCMS) to assess the quality of the manuscripts.Aims
Materials and Methods
We report a systematic review and meta-analysis
of published randomised and quasi-randomised trials evaluating the
efficacy of pre-operative skin antisepsis and cleansing techniques
in reducing foot and ankle skin flora. The post-preparation culture
number (Post-PCN) was the primary outcome. The data were evaluated
using a modified version of the Cochrane Collaboration’s tool. We
identified eight trials (560 participants, 716 feet) that met the inclusion
criteria. There was a significant difference in the proportions
of Post-PCN between hallux nailfold (HNF) and toe web spaces (TWS)
sites: 0.47 Meta-analyses showed that alcoholic chlorhexidine had better
efficacy than alcoholic povidone-iodine (PI) at HNF sites (risk
difference 0.19 (95% CI 0.08 to 0.30); p = 0.0005); a two-step intervention
using PI scrub and paint (S&
P) followed by alcohol showed significantly
better efficacy over PI (S&
P) alone at TWS sites (risk difference
0.13 (95% CI 0.02 to 0.24); p = 0.0169); and a two-step intervention
using chlorhexidine scrub followed by alcohol showed significantly
better efficacy over PI (S&
P) alone at the combined (HNF with
TWS) sites (risk difference 0.27 (95% CI 0.13 to 0.40); p <
0.0001).
No significant difference was found between cleansing techniques. Cite this article:
The aim of this study was to compare the pain caused by the application
of a tourniquet after exsanguination of the upper limb with that
occurring after simple elevation. We used 26 healthy volunteers (52 arms), each of whom acted as
their own matched control. The primary outcome measure was the total pain experienced by
each volunteer while the tourniquet was inflated for 20 minutes.
This was calculated as the area under the pain curve for each individual
subject. Secondary outcomes were pain at each time point; the total
pain experienced during the recovery phase; the ability to tolerate the
tourniquet and the time for full recovery after deflation of the
tourniquet. Aims
Patients and Methods
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.Background
Design
Subtotal or total meniscectomy in the medial or lateral compartment
of the knee results in a high risk of future osteoarthritis. Meniscal
allograft transplantation has been performed for over thirty years
with the scientifically plausible hypothesis that it functions in
a similar way to a native meniscus. It is thought that a meniscal
allograft transplant has a chondroprotective effect, reducing symptoms
and the long-term risk of osteoarthritis. However, this hypothesis has
never been tested in a high-quality study on human participants.
This study aims to address this shortfall by performing a pilot
randomised controlled trial within the context of a comprehensive
cohort study design. Patients will be randomised to receive either meniscal transplant
or a non-operative, personalised knee therapy program. MRIs will
be performed every four months for one year. The primary endpoint
is the mean change in cartilage volume in the weight-bearing area
of the knee at one year post intervention. Secondary outcome measures
include the mean change in cartilage thickness, T2 maps, patient-reported
outcome measures, health economics assessment and complications.Objectives
Methods
Effective analgesia after total knee arthroplasty (TKA) improves
patient satisfaction, mobility and expedites discharge. This study
assessed whether continuous femoral nerve infusion (CFNI) was superior
to a single-shot femoral nerve block in primary TKA surgery completed
under subarachnoid blockade including morphine. We performed an adequately powered, prospective, randomised,
placebo-controlled trial comparing CFNI of 0.125% bupivacaine Objectives
Methods
Femoroacetabular Junction Impingement (FAI) describes abnormalities
in the shape of the femoral head–neck junction, or abnormalities
in the orientation of the acetabulum. In the short term, FAI can
give rise to pain and disability, and in the long-term it significantly increases
the risk of developing osteoarthritis. The Femoroacetabular Impingement
Trial (FAIT) aims to determine whether operative or non-operative
intervention is more effective at improving symptoms and preventing
the development and progression of osteoarthritis. FAIT is a multicentre superiority parallel two-arm randomised
controlled trial comparing physiotherapy and activity modification
with arthroscopic surgery for the treatment of symptomatic FAI.
Patients aged 18 to 60 with clinical and radiological evidence of
FAI are eligible. Principal exclusion criteria include previous
surgery to the index hip, established osteoarthritis (Kellgren–Lawrence
≥ 2), hip dysplasia (centre-edge angle <
20°), and completion
of a physiotherapy programme targeting FAI within the previous 12
months. Recruitment will take place over 24 months and 120 patients
will be randomised in a 1:1 ratio and followed up for three years.
The two primary outcome measures are change in hip outcome score
eight months post-randomisation (approximately six-months post-intervention
initiation) and change in radiographic minimum joint space width
38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Aims
Methods
There is a high rate of mortality in elderly
patients who sustain a fracture of the hip. We aimed to determine
the rate of preventable mortality and errors during the management
of these patients. A 12 month prospective study was performed on
patients aged >
65 years who had sustained a fracture of the hip.
This was conducted at a Level 1 Trauma Centre with no orthogeriatric
service. A multidisciplinary review of the medical records by four
specialists was performed to analyse errors of management and elements
of preventable mortality. During 2011, there were 437 patients aged
>
65 years admitted with a fracture of the hip (85 years (66 to
99)) and 20 died while in hospital (86.3 years (67 to 96)). A total
of 152 errors were identified in the 80 individual reviews of the
20 deaths. A total of 99 errors (65%) were thought to have at least
a moderate effect on death; 45 reviews considering death (57%) were thought
to have potentially been preventable. Agreement between the panel
of reviewers on the preventability of death was fair. A larger-scale
assessment of preventable mortality in elderly patients who sustain
a fracture of the hip is required. Multidisciplinary review panels
could be considered as part of the quality assurance process in
the management of these patients. Cite this article
The maintenance of quality and integrity in clinical
and basic science research depends upon peer review. This process
has stood the test of time and has evolved to meet increasing work
loads, and ways of detecting fraud in the scientific community.
However, in the 21st century, the emphasis on evidence-based medicine
and good science has placed pressure on the ways in which the peer
review system is used by most journals. This paper reviews the peer review system and the problems it
faces in the digital age, and proposes possible solutions. Cite this article:
Fractures of the proximal femur are one of the
greatest challenges facing the medical community, constituting a
heavy socioeconomic burden worldwide. Controversy exists regarding
the optimal treatment for independent patients with displaced intracapsular fractures
of the proximal femur. The recognised alternatives are hemiarthroplasty
and total hip replacement. At present there is no established standard
of care, with both types of arthroplasty being used in many centres.
The principal advantages of total hip replacement are a functional
benefit over hemiarthroplasty and a reduced risk of revision surgery.
The principal criticism is the increased risk of dislocation. We
believe that an alternative acetabular component may reduce the
risk of dislocation but still provide the functional benefit of
total hip replacement in these patients. We therefore propose to
investigate the dislocation risk of a dual-mobility acetabular component
compared with standard polyethylene component in total hip replacement
for independent patients with displaced intracapsular fractures
of the proximal femur within the framework of the larger WHiTE (Warwick
Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article:
Fractures of the proximal femur are one of the
greatest challenges facing the medical community, constituting a
heavy socioeconomic burden worldwide. Controversy exists regarding
the optimal treatment for patients with unstable trochanteric proximal
femoral fractures. The recognised treatment alternatives are extramedullary
fixation usually with a sliding hip screw and intramedullary fixation
with a cephalomedullary nail. Current evidence suggests that best
results and lowest complication rates occur using a sliding hip screw.
Complications in these difficult fractures are relatively common
regardless of type of treatment. We believe that a novel device,
the X-Bolt dynamic plating system, may offer superior fixation over
a sliding hip screw with lower reoperation risk and better function.
We therefore propose to investigate the clinical effectiveness of
the X-bolt dynamic plating system compared with standard sliding
hip screw fixation within the framework of a the larger WHiTE (Warwick
Hip Trauma Evaluation) Comprehensive Cohort Study. Cite this article:
The June 2013 Hip &
Pelvis Roundup360 looks at: failure in metal-on-metal arthroplasty; minimal hip approaches; whether bisphosphonates improve femoral bone stock following arthroplasty; whether more fat means more operative time; surgical infection; vascularised fibular graft for osteonecrosis; subclinical SUFE; and dentists, hips and antibiotics.
Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.
The purpose of this study was to compare the
outcome and complications of endoscopic We conclude that endoscopic release for de Quervain’s tenosynovitis
seems to provide earlier improvement after surgery, with fewer superficial
radial nerve complications and greater scar satisfaction, when compared
with open release. Cite this article:
The osteoinductive properties of demineralised
bone matrix have been demonstrated in animal studies. However, its therapeutic
efficacy has yet to be proven in humans. The clinical properties
of AlloMatrix, an injectable calcium-based demineralised bone matrix
allograft, were studied in a prospective randomised study of 50
patients with an isolated unstable distal radial fracture treated
by reduction and Kirschner (K-) wire fixation. A total of 24 patients
were randomised to the graft group (13 men and 11 women, mean age
42.3 years (20 to 62)) and 26 to the no graft group (8 men and 18
women, mean age 45.0 years (17 to 69)). At one, three, six and nine weeks, and six and 12 months post-operatively,
patients underwent radiological evaluation, assessments for range
of movement, grip and pinch strength, and also completed the Disabilities
of Arm, Shoulder and Hand questionnaire. At one and six weeks and
one year post-operatively, bone mineral density evaluations of both
wrists were performed. No significant difference in wrist function and speed of recovery,
rate of union, complications or bone mineral density was found between
the two groups. The operating time was significantly higher in the
graft group (p = 0.004). Radiologically, the reduction parameters
remained similar in the two groups and all AlloMatrix extraosseous leakages
disappeared after nine weeks. This prospective randomised controlled trial did not demonstrate
a beneficial effect of AlloMatrix demineralised bone matrix in the
treatment of this category of distal radial fractures treated by
K-wire fixation. Cite this article:
We performed a systematic review and meta-analysis
to compare the efficacy of intermittent mechanical compression combined
with pharmacological thromboprophylaxis, against either mechanical
compression or pharmacological prophylaxis in preventing deep-vein
thrombosis (DVT) and pulmonary embolism in patients undergoing hip
or knee replacement. A total of six randomised controlled trials,
evaluating a total of 1399 patients, were identified. In knee arthroplasty,
the rate of DVT was reduced from 18.7% with anticoagulation alone
to 3.7% with combined modalities (risk ratio (RR) 0.27, p = 0.03;
number needed to treat: seven). There was moderate, albeit non-significant,
heterogeneity (I2 = 42%). In hip replacement, there was
a non-significant reduction in DVT from 8.7% with mechanical compression
alone to 7.2% with additional pharmacological prophylaxis (RR 0.84)
and a significant reduction in DVT from 9.7% with anticoagulation
alone to 0.9% with additional mechanical compression (RR 0.17, p
<
0.001; number needed to treat: 12), with no heterogeneity (I2 =
0%). The included studies had insufficient power to demonstrate
an effect on pulmonary embolism. We conclude that the addition of intermittent mechanical leg
compression augments the efficacy of anticoagulation in preventing
DVT in patients undergoing both knee and hip replacement. Further
research on the role of combined modalities in thromboprophylaxis
in joint replacement and in other high-risk situations, such as fracture
of the hip, is warranted.
A total of 159 patients (84 women and 75 men,
mean age of 53 (20 to 87)) with subacromial impingement were randomised
to treatment with subacromial injections using lidocaine with one
of hyaluronic acid (51 patients), corticosteroid (53 patients) or
placebo (55 patients). Patients were followed up for 26 weeks. The
primary outcome was pain on a visual analogue score (VAS), and secondary
outcomes included the Constant Murley score, shoulder pain score,
functional mobility score, shoulder disability questionnaire and
pain-specific disability score. The different outcome measures showed
similar results. After three, six and 12 weeks corticosteroid injections
were superior to hyaluronic acid injections and only at six weeks
significantly better than placebo injections. The mean short-term
reduction in pain on the VAS score at 12 weeks was 7% ( We were not able to show a convincing benefit from hyaluronic
acid injections compared with corticosteroid or placebo injections.
Corticosteroid injections produced a significant reduction in pain
in the short term (three to 12 weeks), but in the long term the
placebo injection produced the best results.
The efficacy of circumpatellar electrocautery in reducing the incidence of post-operative anterior knee pain is unknown. We conducted a single-centre, outcome-assessor and patient-blinded, parallel-group, randomised, controlled trial to compare circumpatellar electrocautery with no electrocautery in total knee replacement in the absence of patellar resurfacing. Patients requiring knee replacement for primary osteoarthritis were randomly assigned circumpatellar electrocautery (intervention group) or no electrocautery (control group). The primary outcome measure was the incidence of anterior knee pain. A secondary measure was the standardised clinical and patient-reported outcomes determined by the American Knee Society scores and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. A total of 131 knees received circumpatellar electrocautery and 131 had no electrocautery. The overall incidence of anterior knee pain at follow-up at one year was 26% (20% to 31%), with 19% (12% to 26%) in the intervention group and 32% (24% to 40%) in the control group (p = 0.02). The relative risk reduction from electrocautery was 40% (9% to 61%) and the number needed to treat was 7.7 (4.3 to 41.4). The intervention group had a better mean total WOMAC score at follow-up at one year compared with the control group (16.3 (0 to 77.7) Our study suggests that in the absence of patellar resurfacing electrocautery around the margin of the patella improves the outcome of total knee replacement.
A new generation of knee prostheses has been introduced with the intention of improving post-operative knee flexion. In order to evaluate whether this goal has been achieved we performed a systematic review and meta-analysis. Systematic literature searches were conducted on MEDLINE and EMBASE from their inception to December 2007, and proceedings of scientific meetings were also searched. Only randomised, clinical trials were included in the meta-analysis. The mean difference in the maximum post-operative flexion between the ‘high-flex’ and conventional types of prosthesis was defined as the primary outcome measure. A total of five relevant articles was identified. Analysis of these trials suggested that no clinically relevant or statistically significant improvement was obtained in flexion with the ‘high-flex’ prostheses. The weighted mean difference was 2.1° (95% confidence interval −0.2 to +4.3; p = 0.07).
We conducted a systematic review and meta-analysis of randomised controlled trials comparing cross-linked with conventional polyethylene liners for total hip replacement in order to determine whether these liners reduce rates of wear, radiological evidence of osteolysis and the need for revision. The MEDLINE, EMBASE and COCHRANE databases were searched from their inception to May 2010 for all trials involving the use of cross-linked polyethylene in total hip replacement. Eligibility for inclusion in the review included the random allocation of treatments, the use of cross-linked and conventional polyethylene, and radiological wear as an outcome measure. The pooled mean differences were calculated for bedding-in, linear wear rate, three-dimensional linear wear rate, volumetric wear rate and total linear wear. Pooled risk ratios were calculated for radiological osteolysis and revision hip replacement. A search of the literature identified 194 potential studies, of which 12 met the inclusion criteria. All reported a significant reduction in radiological wear for cross-linked polyethylene. The pooled mean differences for linear rate of wear, three-dimensional linear rate of wear, volumetric wear rate and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiological osteolysis was 0.40 (95% confidence interval 0.27 to 0.58; I2 = 0%), favouring cross-linked polyethylene. The follow-up was not long enough to show a difference in the need for revision surgery.
We reviewed systematically the published evidence on the effectiveness of antibiotic prophylaxis for the reduction of wound infection in patients undergoing total hip and total knee replacement. Publications were identified using the Cochrane Library, MEDLINE, EMBASE and CINAHL databases. We also contacted authors to identify unpublished trials. We included randomised controlled trials which compared any prophylaxis with none, the administration of systemic antibiotics with that of those in cement, cephalosporins with glycopeptides, cephalosporins with penicillin-derivatives, and second-generation with first-generation cephalosporins. A total of 26 studies (11 343 participants) met the inclusion criteria. Methodological quality was variable. In a meta-analysis of seven studies (3065 participants) antibiotic prophylaxis reduced the absolute risk of wound infection by 8% and the relative risk by 81% compared with no prophylaxis (p <
0.00001). No other comparison showed a significant difference in clinical effect. Antibiotic prophylaxis should be routine in joint replacement but the choice of agent should be made on the basis of cost and local availability.
We compared the bulking and tensile strength of the Pennington modified Kessler, Cruciate and the Savage repairs in an
During revision total hip replacement using morcellised compacted bone allograft, 16 patients were randomised to receive a graft which had been rinsed in either an ibandronate solution or in saline. Patients were assessed by dual energy x-ray absorptiometry after operation and at 3, 6, 12 and 24 months. A region of interest between the tip of the femoral stem and the distal plastic plug was chosen to measure the changes in bone density over time. The study was double-blinded. In all the control patients the bone density decreased during the first three months and then remained constant at this lower level. A large proportion of the mass of the bone graft was lost. In contrast, all patients with grafts treated with bisphosphonate showed a slight increase in bone density. The difference between the groups was highly significant at all points in time. We conclude that rinsing the graft in a bisphosphonate solution prevents its resorption and may therefore reduce the risk of mechanical failure. The treatment is simple, inexpensive, and appears virtually free of risk.
Limited access surgery is thought to reduce post-operative morbidity and provide faster recovery of function. The percutaneous compression plate (PCCP) is a recently introduced device for the fixation of intertrochanteric fractures with minimal exposure. It has several potential mechanical advantages over the conventional compression hip screw (CHS). Our aim in this prospective, randomised, controlled study was to compare the outcome of patients operated on using these two devices. We randomised 104 patients with intertrochanteric fractures (AO/OTA 31.A1–A2) to surgical treatment with either the PCCP or CHS and followed them for one year postoperatively. The mean operating blood loss was 161.0 ml (8 to 450) in the PCCP group and 374.0 ml (11 to 980) in the CHS group (Student’s The PCCP device was associated with reduced intra-operative blood loss, less postoperative pain and a reduced incidence of collapse of the fracture.
