Clinical registries are an important aspect of orthopaedic research in assessing the outcomes of surgical intervention and track medical devices. This study aimed to explore the research methodology available to account for patients lost to follow-up (LTFU) specifically in studies related to arthroscopic intervention and whether the rates of patient LTFU are within the acceptable margins for survey studies. A scoping review, where a literature search for studies from nine arthroscopy registries, was performed on EMBASE, MEDLINE, and the annual reports of each registry. Inclusion criteria included studies with information on patient-reported outcome measures and being based on nine national registries identified. Exclusion criteria included review articles, conference abstracts, studies not based on registry data, and studies from regional, claims-based, or multi-centre registries. Studies were then divided into categories based on method of LTFU analysis used.Abstract
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Aims. The aims were to assess whether joint-specific outcome after total knee arthroplasty (TKA) was influenced by implant design over a 12-year follow-up period, and whether patient-related factors were associated with
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. Methods. 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%
Aims. The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI). Methods. Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. Results. The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Conclusion. Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and
The Accolade®TMZF is a taper-wedge cementless metaphyseal coated femoral stem widely utilized from 2002-2012. In recent years, there have been reports of early catastrophic failure of this implant. Establishing a deeper understanding of the rate and causes of revision in patients who developed aseptic failure in stems with documented concerns about high failure rates is critical. Understanding any potential patient or implant factors which are risk factors for failure is important to inform both clinicians and patients. We propose a study to establish the long-term survival of this stem and analyze patients who underwent aseptic revision to understand the causes and risk factors for failure. A retrospective review was undertaken of all patients who received a primary total hip arthroplasty with an Accolade® TMZF stem at a high-volume arthroplasty center. The causes and timing of revision surgery were documented and cross referenced with the Canadian Institute of Health Information Discharge Abstract Database to minimize
During total knee arthroplasty (TKA), a tourniquet is often used intraoperatively. There are proposed benefits of tourniquet use including shorter duration of surgery, improved surgical field visualization and increased cement penetration which may improve implant longevity. However, there are also cited side effects that include increased post-operative pain, slowed recovery, skin bruising, neurovascular injury and quadriceps weakness. Randomized controlled trials have demonstrated no differences in implant longevity, however they are limited by short follow-up and small sample sizes. The objective of the current study was to evaluate the rates of revision surgery among patients undergoing cemented TKA with or without an intraoperative tourniquet and to understand the causes and risk factors for failure. A retrospective cohort study was undertaken of all patients who received a primary, cemented TKA at a high-volume arthroplasty centre from January 1999 to December 2010. Patients who underwent surgery without the use of a tourniquet and those who had a tourniquet inflated for the entirety of the case were included. The causes and timing of revision surgery were recorded and cross referenced with the Canadian Institute of Health Information Discharge Abstract Database to reduce the
Aims. Tuberculosis (TB) is one of the biggest communicable causes of mortality worldwide. While incidence in the UK has continued to fall since 2011, Bradford retains one of the highest TB rates in the UK. This study aims to examine the local disease burden of musculoskeletal (MSK) TB, by analyzing common presenting factors within the famously diverse population of Bradford. Methods. An observational study was conducted, using data from the Bradford Teaching Hospitals TB database of patients with a formal diagnosis of MSK TB between January 2005 and July 2017. Patient data included demographic data (including nationality/date of entry to the UK), disease focus, microbiology, and management strategies. Disease incidence was calculated using population data from the Office for National Statistics. Poisson confidence intervals were calculated to demonstrate the extent of statistical error. Disease incidence and nationality were also analyzed, and correlation sought, using the chi-squared test. Results. Between January 2005 and July 2017, 109 cases of MSK TB were diagnosed in Bradford. Mean incidence was 1.65 per 100,000 population, per calendar year (SD 0.75). A total of 38 cases required surgical intervention. Low rates of antimicrobial resistance were encountered. A low rate of
Abstract. Background. Since 2012 we have routinely used the cementless Oxford medial unicompartmental knee arthroplasty (mUKA), with microplasty instrumentation, in patients with anteromedial osteoarthritis (AMOA) meeting modern indications. We report the 10-year survival of 1000 mUKA with minimum 4-year follow-up. Methods. National Joint Registry (NJR) surgeon reports were interrogated for each senior author to identify the first 1,000 mUKAs performed for osteoarthritis. A minimum of 4 years follow-up was required. There was no
Introduction. Computer hexapod assisted orthopaedic surgery (CHAOS) has previously been shown to provide a predictable and safe method for correcting multiplanar femoral deformity. We report the outcomes of tibial deformity correction using CHAOS, as well as a new cohort of femoral CHAOS procedures. Materials and Methods. Retrospective review of medical records and radiographs for patients who underwent CHAOS for lower limb deformity at our tertiary centre between 2012–2020. Results. There were 70 consecutive cases from 56 patients with no
Abstract. Objectives. The principle of osteoporotic vertebral compression fracture (OVCF) is fixing instability, providing anterior support, and decompression. Contraindication for vertebroplasty is anterior or posterior wall fracture. The study objectives was to evaluate the efficacy and safety of vertebroplasty with short segmented PMMA cement augmented pedicle screws for OVCF with posterior/anterior wall fracture patients. Methods. A retrospective study of 24 patients of DGOU type-4 (vertebra plana) OVCF with posterior/anterior wall fracture, were treated by vertebroplasty and short segment PMMA cement augmented pedicle screws fixation. Radiological parameters (kyphosis angle and compression ratio) and clinical parameters Visual analogue scale (VAS) and Oswestry disability index (ODI) were analysed. Results. A significant improvement was noted in VAS (preoperative, 7.90 ±0.60; final follow-up 2.90 ± 0.54) and ODI (77.10 ± 6.96 to 21.30 ± 6.70), (P < 0.05). Neurological improvement was noted in all patients. Kyphosis corrected significantly from preoperative 23.20±5.90 to 5.30±1.40 postoperative with 5% (3.30± 2.95) loss of correction at final follow-up. Anterior vertebral height restored significantly from 55.80±11.9% t0 87.6±13.1% postoperative with 4.5±4.0%
Abstract. Objectives. To evaluate the safety and efficacy of vertebroplasty with short segmented cement augmented pedicle screws fixation for severe osteoporotic vertebral compression fractures (OVCF) with posterior/anterior wall fractured patients. Methods. A retrospective study of 24 patients of DGOU type-4 (vertebra plana) OVCF with posterior/anterior wall fracture, were treated by vertebroplasty and short segment PMMA cement augmented pedicle screws fixation. Radiological parameters (kyphosis angle and compression ratio) and clinical parameters Visual analogue scale (VAS) and Oswestry disability index (ODI) were analysed. Results. A significant improvement was noted in VAS (preoperative, 7.90 ± 0.60; final follow-up 2.90 ± 0.54) and ODI (77.10 ± 6.96 to 21.30 ± 6.70), (P < 0.05). Neurological improvement was noted in all patients. Kyphosis corrected significantly from preoperative 23.20 ± 5.90 to 5.30 ± 1.40 postoperative with 5% (3.30 ± 2.95) loss of correction at final follow-up. Anterior vertebral height restored significantly from 55.80 ± 11.9% to 87.6 ± 13.1% postoperative with 4.5 ± 4.0%
The purpose of this investigation is to assess the rate of wear the effect once the “bedding in period”/ poly creep had been eliminated. Creep is the visco-elastic deformation that polyethylene exhibits in the first 6–12 weeks. We also assessed the wear pattern of four different bearing couples in total hip arthroplasty (THA): cobalt-chrome (CoCr) versus oxidized zirconium (OxZir) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly-crosslinked polyethylene (XLPE) acetabular liners. This was a randomized control study involving 92 patients undergoing THA. They were randomized to one of four bearing couples: (1) CoCr/UHMWPE (n= 23), (2) OxZir/UHMWPE (n=21), (3) CoCr/XLPE (n=24), (4) OxZir/XLPE (n=24). Patients underwent a posterior approach from one of three surgeons involved in the study. All patients received a porous-coated cementless acetabular shell and a cylindrical proximally coated stem with 28 mm femoral heads. Each patient was reviewed clinically and radiographically at six weeks, three and 12 months, two, five and 10 years after surgery. Standardized anteroposterior and lateral radiographs were taken. All polyethylene wear was measured by an independent blinded reviewer. Linear and volumetric wear rates were measured on radiographs using a validated computer software (Polyware Rev. 5). Creep was defined as the wear at 6 or 12 weeks, depending on if there was a more than 10% difference between both measurements. If a greater than 10% difference occurred than the later period's wear would be defined as creep. 72 hips were included in analysis after exclusion of seven revisions, three deaths and 10
Objectives. Modern metal-on-metal (MoM) hip resurfacing arthroplasty (HRA), while achieving good results with well-orientated, well-designed components in ideal patients, is contraindicated in women, men with head size under 50 mm, or metal hypersensitivity. These patients currently have no access to the benefits of HRA. Highly crosslinked polyethylene (XLPE) has demonstrated clinical success in total hip arthroplasty (THA) and, when used in HRA, potentially reduces metal ion-related sequelae. We report the early performance of HRA using a direct-to-bone cementless mono-bloc XLPE component coupled with a cobalt-chrome femoral head, in the patient group for whom HRA is currently contraindicated. Methods. This is a cross-sectional, observational assessment of 88 consecutive metal-on-XLPE HRAs performed in 84 patients between 2015 and 2018 in three centres (three surgeons, including the designer surgeon). Mean follow-up is 1.6 years (0.7 to 3.9). Mean age at operation was 56 years (. sd. 11; 21 to 82), and 73% of implantations were in female patients. All patients were individually counselled, and a detailed informed consent was obtained prior to operation. Primary resurfacing was carried out in 85 hips, and three cases involved revision of previous MoM HRA. Clinical, radiological, and Oxford Hip Score (OHS) assessments were studied, along with implant survival. Results. There was no
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
A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.Aims
Methods
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
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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
This prospective study reports longitudinal, within-patient, patient-reported outcome measures (PROMs) over a 15-year period following cemented single radius total knee arthroplasty (TKA). Secondary aims included reporting PROMs trajectory, 15-year implant survival, and patient attrition from follow-up. From 2006 to 2007, 462 consecutive cemented cruciate-retaining Triathlon TKAs were implanted in 426 patients (mean age 69 years (21 to 89); 290 (62.7%) female). PROMs (12-item Short Form Survey (SF-12), Oxford Knee Score (OKS), and satisfaction) were assessed preoperatively and at one, five, ten, and 15 years. Kaplan-Meier survival and univariate analysis were performed.Aims
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The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA). A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size.Aims
Methods
It is not clear which type of casting provides the best initial treatment in adults with a distal radial fracture. Given that between 32% and 64% of adequately reduced fractures redisplace during immobilization in a cast, preventing redisplacement and a disabling malunion or secondary surgery is an aim of treatment. In this study, we investigated whether circumferential casting leads to fewer fracture redisplacements and better one-year outcomes compared to plaster splinting. In a pragmatic, open-label, multicentre, two-period cluster-randomized superiority trial, we compared these two types of casting. Recruitment took place in ten hospitals. Eligible patients aged ≥ 18 years with a displaced distal radial fracture, which was acceptably aligned after closed reduction, were included. The primary outcome measure was the rate of redisplacement within five weeks of immobilization. Secondary outcomes were the rate of complaints relating to the cast, clinical outcomes at three months, patient-reported outcome measures (PROMs) (using the numerical rating scale (NRS), the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and Patient-Rated Wrist/Hand Evaluation (PRWHE) scores), and adverse events such as the development of compartment syndrome during one year of follow-up. We used multivariable mixed-effects logistic regression for the analysis of the primary outcome measure.Aims
Methods