Purpose: Although blinding of outcome assessors is crucial to minimize bias in clinical trials, the majority of surgical trials do not blind these individuals in part due to practical difficulties inherent in surgical interventions. We devised and tested techniques to blind outcome assessors in trials of femoral neck fracture fixation. Method: We developed three techniques to mask radiographs of femoral neck fractures fixated with cancellous screws or dynamic hip screws: Blackout, Subtraction, and Overlay. 50 orthopaedic trauma surgeons assessed 32 radiographs blinded with each of these techniques. We considered:. The ability to mask the surgeons (the proportion of radiographs in which the surgeons were able to correctly identify the implant and the Bang Blinding Index);. Surgeons’ ability to accurately rate the quality of reduction in blinded images;. Surgeons’ perceptions of difficulties rating the blinded images. Results: All three techniques achieved low proportions of correct identification of cancellous or dynamic screws (14.9% for Blackout, 26.9% for Subtraction, 22.1% for Overlay) and high proportions of “don’t know” responses (72.3%, 48.4%, 52.8% respectively). The Bang Blinding Indices were close to 0 (perfect blinding) for all three techniques (−0.024 to 0.008). The interrater reliability of quality of reduction in the blinded images (ICC = 0.55 – 0.57) was similar to the reliability of the unblinded radiographs (ICC = 0.60). Surgeons perceived the Overlay images as much more difficult to rate in 6.9% of radiographs, compared with 9.7% of Subtraction images (p=0.25) and 28.0% of Blackout images (p< 0.001). Conclusion: Three techniques of blinding radiographs of femoral neck fractures successfully mask surgeons to the type of implant fixated, do not compromise reliability of reduction ratings, and do not make the rating process substantially more difficult. Trialists should explore creative approaches such as these to blind as many individuals as possible when designing trials, and should incorporate rigorous approaches to testing the success of blinding

Background: While surgical trials can rarely blind surgeons or patients, they can often blind outcome assessors. The aim of this systematic review was threefold:

1) to examine the reporting of outcome measures in orthopaedic trials,

Specifically, we focused on an association between blinding of outcome assessment and the size of the reported treatment effect; in other words: does blinding of outcome assessors matter?

Methods: We reviewed 32 identified RCTs published in the Journal of Bone and Joint Surgery (American Volume), in 2003 and 2004 for the appropriate use of outcome measures. These RCTs represented 3.4% (32/938) of all studies published during that time period. All RCTs were reviewed by two of us for:

1) the outcome measures used and

We calculated the magnitude of treatment effect of blinded compared to un-blinded outcome assessors.

Results: The methodological validation and clinical usefulness of the clinician-based, patient-based, and generic outcome instruments varied. Ten of the 32 RCTs (31%) used a modified outcome instrument. Of these 10 trials, 4 (40%) failed to describe how the outcome instrument was modified. Nine (90%) of the 10 articles did not describe how their modified instrument was validated and retested. Sixteen (50%) of the 32 RCTs did not report blinding of outcome assessors where blinding would have been possible. Among those studies with continuous outcome measure, unblinded outcomes assessment was associated with significantly larger treatment effects (standardized mean difference 0.76 versus 0.25, p=0.01). Similarly, in those studies with dichotomous outcomes, unblinded outcomes assessments were associated with significantly greater treatment effects (Odds ratio 0.13 versus 0.42, unblinded versus blinded, p< 0.001). The ratio of odds ratios (unblinded to blinded) was 0.31 suggesting that unblinded outcomes assessment was associated with an exaggeration of the benefit of a treatment’s effectiveness in our cohort of studies.

Conclusion: Reported outcomes in RCTs are often modified and rarely validated. Half of the RCTs did not blind outcome assessors even though blinding of outcome assessors would have been feasible in each case. Treatment effects may be exaggerated if outcome assessors are unblinded. Emphasis should be placed on detailed reporting of outcome measures to facilitate generalization. Outcome assessors should be blinded where possible to prevent bias.

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: Bone Joint Res 2013;2:245–7.

Alcohol hand rubs, endorsed by WHO and NICE guidelines, are integral to modern surgical practices. Our objective was to assess how different scrubbing methods impact overall water usage by the surgical team, shedding light on variations among team members and their environmental implications. Over three consecutive arthroplasty lists spanning a week, water usage during scrubbing was observed for the operating team. Blinding all team members, including the anesthetist, consultant surgeon, orthopaedic registrar, orthopaedic SHO, and scrub nurse, during water usage calculations was implemented. Automated taps, using motion sensors, posed a challenge due to variable water quantity, necessitating water flow calculations per sensor movement. The senior surgeon, with over 20 years of experience, follows a traditional approach, starting with a morning prescrub and using an alcohol tub for each case, except when hands are soiled. We observed a total of 14 cases of lower limb primary arthroplasty. The cumulative water usage for scrubbing by the entire team was 193 liters, yielding a mean of 13.8 liters (±1.85) per case. The anaesthetist demonstrated the most conservative water usage, utilizing a total of 11.85 liters with a mean of 0.84 liters per case. Notably, alcohol rub was employed for half of the observed time, contributing to this efficient use. The senior operating surgeon used a total of 15.6 liters, averaging 1.1 liters per case. In contrast, the SHO and the registrar exhibited the highest water consumption, totaling 121.6 liters and yielding a mean of 5.7 liters per case. The nurses’ collective water usage for scrubbing amounted to 44.8 liters. Adopting alcohol rub, as endorsed by WHO, results in a remarkable 10-fold reduction in water usage, aligning with global health guidelines. This highlights significant potential for resource conservation in surgical procedures, presenting a practical and environmentally conscious approach to surgical scrubbing practices

Total knee arthroplasty is associated with early postoperative pain. Appropriate pain management is important to facilitate postoperative rehabilitation and positive functional outcomes. This study compares outcomes in TKA with three techniques; local infiltration analgesia, single shot femoral nerve block and intrathecal morphine. Methods. Forty-five patients undergoing elective primary Total Knee Arthroplasty (TKA) with were randomized into one of three groups in a double blind proof of concept study. Study arm 1 received local infiltration analgesia ropivacaine intra-operatively, an elastomeric device of ropivacaine for 24 hours post-op. Study arm 2 received a femoral nerve block of ropivacaine with placebo local infiltration analgesia and placebo intrathecal morphine. Study arm 3 received intrathecal morphine, placebo femoral nerve block and placebo local infiltration analgesia. All patients received standardized pre-operative, intraoperative and Post-operative analgesic medication. Participants were mobilized at 4 hrs, 24hrs and 48 hrs post operation. Range of Motion, Visual Analogue Scale (VAS) pain intensity scores and two minute walk test and Timed Up and Go test were performed. Postoperative use of analgesic drugs was recorded. Knee Society Score (KSS), Oxford Knee Score and Knee Injury and Osteoarthritis Outcome Score (KOOS) were completed at preoperative and 6 weeks post op. Results. Preliminary results of 32 participants convey the positive outcomes after total knee replacement demonstrated by the improvement in Oxford Knee Score and Knee Osteoarthritis Outcome score. There are marked improvements in the 2-minute walk tests at the six week time-point. At day one post-operative only 5 participants were unable to walk. Patient-controlled analgesia was used on 5 occasions on day one, 2 of which continued on day two. Sedation scores were recorded in six participants on day one and 2 on day two. Nausea was reported in 5 cases on day one and 9 on day two. Urinary catheter was needed in 5 cases on day one. Importantly the study remains blinded, therefore an analysis of the three study arms is not available and is therefore currently difficult to report on the statistical significance. There will be further assessment of the efficacy of analgesia using VAS pain scores, analgesia consumption and side effects collected preoperatively, 0–24hrs and 24–48 hours postoperatively between the three randomized groups. The assessment of functional outcomes will be measured between the three groups by comparing the ability to mobilize the first 4 hrs after surgery, maximal flexion and extension, two minute walk test and timed up-and-go preoperatively, on postoperative day 1 and 2 and 6 weeks. Conclusion. Results from the study will provide important information for the management of TKA in the hospital setting. We anticipate completion of all 45 surgeries in the next 2 months. The Blinding codes with be broken thereafter and full data analysis performed. The comparison of the three commonly used analgesic techniques and mobilization outcomes will allow enhanced management of patient's post-operative pain with earlier discharge from hospital an lower complication rates

Purpose: Unbiased outcome assessment in orthopedic clinical trials has the potential to improve trial validity. The approaches used to limit bias in outcome assessment in orthopaedic trials remain unclear. The objective of this systematic review was to assess the reporting and process of outcomes assessment practices in the current orthopaedic trauma literature. Method: We searched eight high-impact-factor medical and orthopaedic journals manually and using the MED-LINE electronic database for reports of randomized controlled trials published from 2005 to 2008 pertaining to the surgical treatment of trauma-related injuries. Two reviewers independently determined study eligibility and extracted relevant data from included trials. Results: Of the 7910 citations identified during our search, 47 randomized controlled trials, which included a total of 4706 patients, met our inclusion criteria. Of 47 studies, 39 (83%) provided a statement to describe some process of outcome assessment and 29 (74%) reported using an unblinded individual as the outcome adjudicator. Four studies (10%) reported using a second assessor to verify outcome measurements, and three studies (8%) reported the use of an adjudication committee to reach endpoint decisions via consensus. No included study provided a rationale for the use of their chosen approach to adjudication. The most commonly adjudicated outcomes included fracture healing (15 studies), reoperation rate (6 studies), and general clinical assessment of post-operative complications and limb function (30 studies), mainly by orthopaedic surgeons. Blinding of outcome assessors was not performed or unclear in 38 studies (81%). Conclusion: Despite the importance of the outcome assessment process in orthopedic trauma trials, key aspects of outcome assessment are insufficiently reported. This limits the ability of readers to assess the validity of published trials

A prospective clinical investigation to determine the optimum knee flexion angle for the ‘skyline’ patellofemoral joint radiograph. Plain radiography of the patello-femoral joint includes the axial or ‘skyline’ radiograph. The optimum knee flexion angle for making this image remains unclear. We therefore performed a prospective clinical study in which patients underwent three skyline radiographs with knee flexion angles of 30(or minimal flexion), 50 and 90 degrees. The patients were new patients, aged between 12 and 30, presenting to a knee clinic with anterior knee pain. Two observers evaluated the radiographs, making a standardised series of measurements. Blinding was organised so that the observers were unable to use any information other than the radiographic image alone. One observer evaluated all the films on two separate occasions to allow calculation of intra- and interassessor agreement. There were 67 knees from 46 patients. There was a high level of intra- and inter-observer agreement. There were a number of patients in which the radiographic appearance of the patello-femoral varied markedly between the different views; in all cases the abnormality was best demonstrated by the 30-degree view. There were however a number of minimal flexion views in which the film contained incomplete information because part of the patello-femoral joint was missing from the image. We conclude that whilst a minimal flexion skyline view is the most sensitive method for the detection of patellar tilt and subluxation, not all knees can be successfully imaged at the required position. A flexible approach is therefore needed, to obtain satisfactory images at minimal flexion

Aims

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.

Aims

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.

Aims

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.

Aims

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.

Aims

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.

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: Bone Joint J 2024;106-B(2):114–120.

Aims

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.

Aims

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.

Aims

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.

Aims

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.

Aims

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.

Aims

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.

Aims

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).