Introduction. Polyacrylamide hydrogel (iPAAG. 1. ), is CE marked for treating symptomatic knee osteoarthritis (OA), meeting the need for an effective, long-lasting, and safe non-surgical option. This study evaluates the efficacy and safety of a single 6 ml intra-articular injection of iPAAG in participants with moderate to severe knee OA over a 5-year post-treatment period, presenting data from the 4-year follow up. Method. This prospective multicentre study (3 sites in Denmark) involved 49 participants (31 females) with an average age of 70 (range 44 – 86 years). They received a single 6 mL iPAAG injection. All participants provided informed consent and re-consented to continue after 1 year. The study followed GCP principles and was approved by Danish health authorities and local Health Research Ethics committees. Twenty-seven participants completed the 4-year follow-up. The study evaluated WOMAC pain, stiffness, function, and Patient Global Assessment (PGA) of disease impact. Changes from baseline were analysed using a mixed model for repeated measurement (MMRM). Sensitivity analyses were applied on the extension data, where the MMRM analysis was repeated only including patients in the extension phase and an ANCOVA model was used, replacing missing values at 4-years with baseline values (BOCF).
Osteoarthritis (OA) affects the whole joint and leads to chronic pain. The sympathetic nervous system (SNS) seems to be involved in OA pathogenesis, as indicated by
A hot swollen joint is a commonly encountered condition in clinical practice. With a broad range of differentials, septic arthritis (SA) is perhaps one of the most concerning. Treated by culture-specific antibiotics and arthroscopic lavage, some patients require multiple washouts. We aimed to determine: (1) What are the risk factors for development of SA? (2) What are the risk factors for repeat washout in SA patients? (3) What are the important clinical differences between a periprosthetic joint infection (PJI) and SA cohort? All patients presenting to the emergency department, orthopaedic, and rheumatology clinics between January 2020 to January 2021 with a hot, swollen joint were retrospectively evaluated. Patients with previous trauma on the ipsilateral joint, with data missing from their medical records in any of the variables required for analysis, <24 months follow-up were excluded. Variables of interest in the three-month period preceding the diagnosis of SA were compared between SA and non-SA patients. Factors with a p-value of p<0.100 in univariate analysis were included in a stepwise multivariate logistic regression model. Similar analyses were performed to compare SA patients with multiple washouts with those needing one washout. Demographical and clinical data for PJI patients were collected to delineate important differences with SA cohort. 211 patients were included (SA:28;PJI:24;pseudogout:32;gout:26;others:101). Multivariate analysis showed rheumatoid arthritis (RA), skin infection, and liver disease were risk factors for SA. Amongst patients with septic arthritis, multivariate analysis showed that WBC levels above normal limits (3.6-10.5×109 cells/L) and RA were risk factors for multiple washouts. Between the SA and PJI cohorts, BMI (p=0.002) was significantly lower in the former, whilst WBC level (p=0.023) and CRP (p<0.0001) was significantly higher in the former. Early diagnosis of septic arthritis requires understanding the risk factors, namely RA, skin infection, and liver disease. Considering PJI and septic arthritis as the same entity can lead to wrong clinical judgement, and clinicians should be aware of important differences. We believe that the models in this study are of prognostic value to clinicians who are presented with the common presenting compliant of a hot swollen joint.
Traumatic acute or chronic tendon injuries are a wide clinical problem in modern society, resulting in important economic burden to the health system and poor quality of life in patients. Due to the low cellularity and vascularity of tendon tissue the repair process is slow and inefficient, resulting in mechanically, structurally, and functionally inferior tissue. Tissue engineering and regenerative medicine are promising alternatives to the natural healing process for tendon repair, especially in the reconstruction of large damaged tissues. The aim of TRITONE project is to develop a smart, bioactive implantable 3D printed scaffold, able to reproduce the structural and functional properties of human tendon, using FDA approved materials and starting from MSC and their precursor, MPC cell mixtures from human donors. Total cohort selected in the last 12 months was divided in group 1 (N=20) of subjects with tendon injury and group 2 (N=20) of healthy subject. Groups were profiled and age and gender matched. Inclusion criteria were age>18 years and presence of informed consent. Ongoing pregnancy, antihypertensive treatment, cardiovascular diseases, ongoing treatment with anti-aggregants, acetylsalicylic-acid or lithium and age<18 years were exclusion criteria. Firstly, we defined clinical, biological, nutritional life style and genetic profile of the cohort. The deficiency of certain nutrients and sex hormonal differences were correlated with tendon-injured patients. It was established the optimal amount of MPC/MSC human cell (collected from different patients during femoral neck osteotomy). Finally, most suitable biomaterials for tendon regeneration and polymer tendon-like structure were identified. Hyaluronic acid, chemical surface and soft-molecular imprinting (SOFT-MI) was used to functionalize the scaffold. These preliminary results are promising. It will be necessary to enroll many more patients to identify genetic status connected with the onset of tendinopathy. The functional and structural characterization of smart bioactive tendon in dynamic environment will represent the next project step.
Abstract. Shoulder replacements have evolved and current 4th generation implants allow intraoperative flexibility to perform anatomic, reverse, trauma, and revision shoulder arthroplasty. Despite high success rates with shoulder arthroplasty, complication rates high as 10–15% have been reported and progressive glenoid loosening remains a concern. Objectives. To report medium term outcomes following 4th generation VAIOS® shoulder replacement. Methods. We retrospectively analysed prospectively collected data following VAIOS® shoulder arthroplasty performed by the senior author between 2014–2020. This included anatomical (TSR), reverse(rTSR), revision and trauma shoulder replacements. The primary outcome was implant survival (Kaplan-Meier analysis). Secondary outcomes were Oxford Shoulder Scores (OSS), radiological outcomes and complications.
The National Hip Fracture Database (NHFD) is a clinically led web based audit used to inform national policy guidelines. The aim of this audit was to establish the accuracy of completion of NHFD v13.0 theatre collection sheets, identify common pitfalls and areas of good practice, whilst raising awareness of the importance of accuracy of this data and the manner in which it reflects performance of CAH Trauma & Orthopaedic unit in relation to national guidelines. Our aim was to improve completion up to >80% by the operating surgeon and improve overall accuracy. The methodology within both cycles of the audit were identical. It involved reviewing the NHFD V13.0 completed by the operating surgeon and cross-checking their accuracy against clinical notes, operation notes, imaging, anaesthetic charts and A&E admission assessment. Following completion of cycle 1 these results were presented, and education surrounding V13.0 was provided, at the monthly trust audit meeting. At this point we introduced a sticker onto the pre-operative checklist for Hip fractures. This included time of admission and reason for delay. We then completed a re-audit. Cycle-1 included 25 operations, 56% (n=14) had a completed V13.0 form. Of these 21% (n=3) were deemed to be 100% accurate. Cycle-2 included 31 operations (between April – June 21) 81% (n=25) had a completed intra-operative from and showed an increase in accuracy to 56% (n=14) Through raising awareness, education and our interventions we have seen a significant improvement in the completion and accuracy of v13.0. Although 100% accuracy was not achieved its clear that education and intervention will improve compliance over time. Through the interventions that we have implemented we have shown that it is possible to improve completion and accuracy of the NHFD V13.0 theatre collection sheet locally and feel this could be implemented nationally.
7–20 % of the patients with a total knee arthroplasty (TKA) are dissatisfied without an indication for revision. Therapeutic options for this patient population with mostly a lack of quadriceps strength are limited. The purpose of this study is to evaluate the effect of six weeks low load resistance training with blood flow restriction (BFR) on the clinical outcome in these unhappy TKA patients. Thirty-one unhappy TKA patients (of the scheduled fifty patients) without mechanical failure were included in this prospective study since 2022. The patients participate in a supervised resistance training combined with BFR, two times a week during nine weeks. Patients were evaluated by the Knee Osteoarthritis Outcome Score (KOOS), Knee Society Score: satisfaction (KSSs) and the Pain Catastrophizing Scale (PCS). Functionality was tested using the Six Minute Walk Test (6MWT) and the 30-Second Chair Stand Test (30CST). Follow-up took place at six weeks, three months and six months after the start. Six weeks training with BFR provided statistically significant improvements in all the KOOS subscales compared to the baseline, especially for symptoms (55.1 (±15.4) versus 48.0 (±16.5); p<0.001), activities in daily living (50.3 (±21.1) versus 43.7 (±17.2); p<0.00) and quality of life (24.6 (±18.5) versus 17.3 (±13.0); p<0.001). The PCS reduced from 27.4 (±11.0) to 23.2 (±11.4) at six weeks (p<0.01), whereas the KSSs increased from 11.8 (±6.5) to 14.9 (±7.6) (p=0.021). Both the 6MWT and the 30CST improved statistically significant from respectively 319.7 (±15.0) to 341.6m (±106.5) (p<0.01) and 8.6 (±3.9) to 9.3 times (±4.5) (p<0.01). Blood flow restriction appears to enhance the quality of life and functional performance of unhappy TKA patients. Based on these preliminary results, BFR seems to be a promising and valuable alternative for these TKA patients with limited therapeutic options.
Introduction and Objective. Difficult primary total knee arthroplasty (TKA) and revision TKA are high demanding procedures. Joint exposure is the first issue to face off, in order to achieve a good result. Aim of this study is to evaluate the clinical and radiological outcomes of a series of patients, who underwent TKA and revision TKA, where tibial tubercle osteotomy (TTO) was performed. Materials and Methods. We retrospectively reviewed a cohort of 79 consecutives TKAs where TTO was performed, from our Institution registry. Patients were assessed clinically and radiographically at their last follow-up (mean, 7.4 ± 3.7 years). Clinical evaluation included the Knee Society Score (KSS), the pain visual analogue scale (VAS), and range of motion. Radiological assessment included the evaluation of radiolucent lines, osteolysis, cortical bone hypertrophy, time of bone healing of the TTO fragment, and the hardware complication.
Introduction and Objective. The surgical strategy for acetabular component revision is determined by available host bone stock. Acetabular bone deficiencies vary from cavitary or segmental defects to complete discontinuity. For segmental acetabular defects with more than 50% of the graft supporting the cup it is recommended the application of reinforcement ring or ilioischial antiprotrusio devices. Acetabular reconstruction with the use of the antiprotrusion cage (APC) and allografts represents a reliable procedure to manage severe periprosthetic deficiencies with highly successful long-term outcomes in revision arthroplasty. Objective. We present our experience, results, critical issues and technical innovations aimed at improving survival rates of antiprotrusio cages. Materials and Methods. From 2004 to 2019 we performed 69 revisions of the acetabulum using defrosted morcellized bone graft and the Burch Schneider anti-protrusion cage. The approach was direct lateral in 25 cases, direct anterior in 44. Patients were re-evaluated with standard radiography and clinical examination.
Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts. Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion. Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure. The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease. This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming.
Introduction. Simultaneous correction of knee varus malalignment with medial open wedge high tibial osteotomy (MOWHTO) combined with anterior cruciate ligament (ACL) surgery aims to address symptomatic unicompartmental osteoarthritis in addition to restore knee stability in order to improve outcomes. The aim of this study is to present at least 5 years results of 32 patients who underwent simultaneous knee realignment osteotomy with ACL surgery. Methods. Patients with symptomatic instability due to chronic ACL deficiency or failed previous ACL surgery together with a varus malalignment of ≥6°, previous medial meniscectomy and symptomatic medial compartment pain who were treated with MOWHTO combined with ACL surgery were enrolled. ACL surgery was performed with the anatomical single bundle all-inside technique using TightRope. ®. RT (Arthrex, Naples, FL, USA) and MOWHTO using TomoFix. ®. medial high tibia plate (DePuy Synthes, Raynham, MA, USA) in all cases. Patients were evaluated preoperatively and at 6 months, 12 months and annually postoperatively using the Knee Injury and Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS) and Euroqol's Visual Analogue Score (VAS) for pain.
Purpose. Ultrasound of the neonatal and infantile hip is a useful tool in diagnosis and treatment of the developmental dysplasia of the hip (DDH), especially given the fact that numerous cases of DDH do not present any findings in the clinical examination. Methods. Between January 2014 and May 2020, 10536 (5273 neonates and infants, 53% girls, 47% boys) consecutive neonatal and infantile hip joints were studied using the Graf Hip Ultrasound method.
Introduction and Objective. The aim of this study was to evaluate whether CT-based pre-operative planning, integrated with intra-operative navigation could improve glenoid baseplate fixation and positioning by increasing screw length, reducing number of screws required to obtain fixation and increasing the use of augmented baseplate to gain the desired positioning. Reverse total shoulder arthroplasty (RSA) successfully restores shoulder function in different conditions. Glenoid baseplate fixation and positioning seem to be the most important factors influencing RSA survival. When scapular anatomy is distorted (primitive or secondary), optimal baseplate positioning and secure screw purchase can be challenging. Materials and Methods. Twenty patients who underwent navigated RSA (oct 2018 and feb 2019) were compared retrospectively with twenty patients operated on with a conventional technique. All the procedures were performed by the same surgeon, using the same implant in cases of eccentric osteoarthritis or complete cuff tear. Exclusion criteria were: other diagnosis as proximal humeral fractures, post-traumatic OA previously treated operatively with hardware retention, revision shoulder arthroplasty.
Introduction and Purpose. Metacarpal fractures constitute approximately one third of all hand fractures. The majority of these fractures are treated by conservative non-surgical methods. The aim of this study is to obtain the appropriate anatomical alignment of the fracture with dynamic metacarpal stabilization splint (DMSS) and to maintain the proper bone anatomy until the union is achieved. In addition, by comparing this method with short arm plaster splint (SAPS) application, it is aimed to evaluate whether patients are superior in terms of comfort, range of motion (ROM) and grip strength. Materials and Methods. In our study, SAPS or DMSS was applied to the patients with 5th metacarpal neck fracture randomly after fracture reduction and followed for 3 months. A total of 119 patients with appropriate criteria were included in the study. Radiological alignment of the fracture and amount of joint movements were evaluated during follow-up. Grip strength was evaluated with Jamar dynamometer. EQ-5D-5L and VAS scores were used for clinical evaluation.
The medial opening-wedge high tibial osteotomy (OW-HTO) is an accepted option to treat the isolated medial compartment osteoarthritis (OA) in varus knee. Despite satisfactory outcomes were described in literature, consistent complication rate has been reported and the provided accuracy of coronal alignment correction using conventional HTO techniques falls short. Patient specific instrumentations has been introduced with the aim to reduce complications and to improve the intra-operative accuracy according to the pre-operative plan, which is responsible for the clinical result of the surgery. In this talk, an overview of the clinical results of HTO patient specific instrumentation available in literature will be performed. Moreover, preliminary intra-operative and clinical results of a new customised 3-D printed cutting guide and fixation plate for OW-HTO will be presented.
The purpose of this study was to compare the outcomes of arthroscopic unilateral surgery and simultaneous bilateral surgery for posterior ankle impingement syndrome (PAIS) in athletes and to evaluate the usefulness of simultaneous bilateral surgery. A total 48 hindfeet of 41 athletes (14 hindfeet of 14 males, 34 hindfeet of 27 females) who underwent arthroscopic surgery for PAIS were studied. Japanese society for surgery of the foot (JSSF) score and visual analogue scale (VAS) were compared before and after surgery, using Wilcoxon signed-rank test. The operation time and the time to return to sports activity were compared in 10 hindfeet of 5 patients who underwent simultaneous bilateral surgery and 38 hindfeet of 36 patients who underwent unilateral surgery, using Wilcoxon rank sum test. Classic ballet was the most common type of sport that caused PAIS (59%, 24/41 athletes). Soccer (10%, 4/41 athletes), baseball (10%, 4/41 athletes), badminton (5%, 2/41 athletes), volleyball (5%, 2/41 athletes), and athletics (5%, 2/41 athletes) followed. The JSSF score improved significantly from 72.7 preoperatively to 98.9 postoperatively in unilateral surgery, and significantly improved from 75.2 preoperatively to 99.0 postoperatively in simultaneous bilateral surgery. VAS significantly decreased from 64.7 preoperatively to 4.8 postoperatively in unilateral surgery, and significantly decreased from 72.7 preoperatively to 1.0 postoperatively in simultaneous bilateral surgery. The operating time was 53.7 minutes on average for unilateral surgery and 101.0 minutes for simultaneous bilateral surgery, significantly longer in bilateral simultaneous surgery. The mean time to return to sports activity was 4.8 weeks for unilateral surgery and 9.6 weeks for simultaneous bilateral surgery, significantly longer in simultaneous bilateral surgery. Both unilateral and simultaneous bilateral surgeries for PAIS in athletes were useful. It should be noted that the operating time and the time to return to sports will be longer. However, considering the 2 times hospitalizations and 2 times surgeries, simultaneous bilateral surgery is one of the treatment options for PAIS.
Abstract. Objective. To compare the periprosthetic fracture mechanics between a collared and collarless fully coated cementless femoral stem in a composite femur. Methods. Two groups of six composite femurs (‘Osteoporotic femur’, SawBones, WA USA) were implanted with either a collared (collared group) or collarless (collarless group) cementless femoral stem which was otherwise identical by a single experienced surgeon. Periprosthetic fractures of the femur were simulated using a previously published technique. High speed video recording was used to identify fracture mechanism. Fracture torque and angular displacement were measured and rotational work and system stiffness were estimated for each trial.
Osteomyelitis is an infection of bone or bone marrow with a concomitant inflammation involving the bone marrow and the surrounding tissues. Chronic osteomyelitis is historically treated in a two-stage fashion with antibiotic-loaded polymethylmethacrylate as local antibacterial therapy. Two-stage surgeries are associated with high morbidity, long hospitalization and high treatment costs. Next to antibiotic releasing biomaterials, S53P4 bioactive glass is a biomaterial that enables one-stage surgery in local treatment of chronic osteomyelitis. S53P4 bioactive glass is gaining interests in recent years in clinical treatment of chronic osteomyelitis in a one-stage fashion due to its antibacterial and bone regenerating capacities. By changing local pH and osmotic pressure S53P4 bioactive glass attack bacteria in a different way as compared to antibiotics. In this presentation, we will present current clinical treatment options for osteomyelitis, clinical results and level of evidence of various biomaterials used in osteomyelitis treatment. In addition, the clinical results and health-economic results of S53P4 bioactive glass will be detailed. Thereafter a summary of the current standing across the board in osteomyelitis treatment will be provided.
Background. Narcotics are commonly prescribed for pain control of orthopedic trauma but injury pattern and severity, in addition to patient factors, result in varying dosing requirements. These factors, coupled with increasing pressure to reduce narcotic consumption, highlight the importance of narcotic stewardship and comprehension of patient factors leading to higher pain control demands. The purpose of this study is to understand whether or not narcotic consumption is greater in patients who present to the emergency department with positive drug screen (utox) for illicit substances. Methods. We performed a retrospective chart review of 300 consecutive trauma activations during the 2015 calendar year. Of the patient cohort, 226 patients received a utox screen which represents the cohort for this study. Utox screen included amphetamines, barbiturates, benzodiazepines, cocaine, ethanol, methadone, phencyclidine, and tetrahydrocannabinol. Opioids given hospital stay were converted to oral morphine equivalents using ratios available in the current literature. The average daily equivalent was calculated for their total hospital stay and recorded. Patient injury severity score (ISS), age, gender, length of stay, readmission rates were also recorded. Statistical comparisons were made using SPSS version 23 (IBM, Aramonk, NY). Data distributions were examined with the Shapiro-Wilk test of normality between group comparisons were made with Mann Whitney U tests. Chi squared test was used to evaluate categorical data. Significance was set at p=0.05.
Background. The objective was to evaluate the benefit that could be obtained in terms of pain and efficacy with processed segmental allografts on 20 patients in meniscal repair treatment. Methods. Segmental meniscal allografts were extracted from tibial plateaux during total knee arthroplasties on lateralised osteoarthritis and selected on macroscopic integrity criteria. They underwent decellularisation and deproteinisation processes to obtain a sterile collagenous matrix with glycosaminoglycans removal. Under arthroscopy, the grafts (50mm length) were fixed at the posterior horn and at the meniscosynovial wall. The main evaluation criterion was the IKDC subjective knee score evolution. Secondary criteria were the meniscus morphology (Magnetic Resonance Imaging after 12 months) and the recellularisation (biopsy after 1 year). Material. In this Phase II monocentric, prospective and open-label clinical trial, a total of 10 male patients (mean age: 39 years [24–50]) were enrolled. They were symptomatic (IKDC score < 70), did not suffer from osteoarthritis (Kellgreen-Lawrence score < Grade 2) and presented a meniscal tissue defect on the posterior and/or medium segment, respecting the posterior horn. Exclusion criteria were lax knees, significant frontal deviations, pre-osteoarthritis and obese patients.