Describe a statistical and economic analysis plan for the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) randomized controlled trial. DRAFFT2 is a multicentre, parallel, two-arm randomized controlled trial. It compares surgical fixation with K-wires versus plaster cast in adult patients who have sustained a dorsally displaced fracture of the distal radius. The primary outcome measure is the Patient-Rated Wrist Evaluation (PRWE, a validated assessment of wrist function and pain) at 12 months post-randomization. Secondary outcomes are measured at three, six, and 12 months after randomization and include the PWRE, EuroQoL EQ-5D-5L index and EQ-VAS (visual analogue scale), complication rate, and cost-effectiveness of the treatment.Aims
Methods
It has been hypothesized that a unicompartmental knee arthroplasty (UKA) is more likely to be revised than a total knee arthroplasty (TKA) because conversion surgery to a primary TKA is a less complicated procedure. The purpose of this study was to determine if there is a lower threshold for revising a UKA compared with TKA based on Oxford Knee Scores (OKSs) and range of movement (ROM) at the time of revision. We retrospectively reviewed 619 aseptic revision cases performed between December 1998 and October 2018. This included 138 UKAs that underwent conversion to TKA and 481 initial TKA revisions. Age, body mass index (BMI), time in situ, OKS, and ROM were available for all patients.Aims
Methods
During the 11-year-period from 1970 to 1980, 799 total hip arthroplasties with metal-on-plastic prostheses were performed for primary osteoarthritis. In all cases high viscosity cement was used, but not under pressure; acetabular cartilage was removed, but the femoral canal was not plugged. The rate of revision and risk factors were evaluated by survivorship analysis. The overall cumulative revision rates were 11%, 14% and 19% after 8, 10, and 14 years respectively. When prophylactic antibiotics were not used, there was a significant risk of revision for infection. The risk of revision for mechanical loosening of both the acetabular and femoral components was significantly increased for men, younger patients, and if a snap-fit prosthesis with a 35 mm head and short wedged stem was used. The survivorship findings were validated by multivariate
Aseptic loosening of the tibial component is a frequent cause of failure in primary total knee arthroplasty (TKA). Management options include an isolated tibial revision or full component revision. A full component revision is frequently selected by surgeons unfamiliar with the existing implant or who simply wish to “start again”. This option adds morbidity compared with an isolated tibial revision. While isolated tibial revision has a lower morbidity, it is technically more challenging due to difficulties with exposure and maintaining prosthetic stability. This study was designed to compare these two reconstructive options. Patients undergoing revision TKA for isolated aseptic tibial loosening between 2012 and 2017 were identified. Those with revision implants or revised for infection, instability, osteolysis, or femoral component loosening were excluded. A total of 164 patients were included; 88 had an isolated tibial revision and 76 had revision of both components despite only having a loose tibial component. The demographics and clinical and radiological outcomes were recorded.Aims
Methods
We have assessed the final strength of the deltoid in 121 patients who had repair of isolated or combined lesions of the axillary (circumflex) nerve and were available for
We propose a state-of-the-art temporary spacer, consisting of a cobalt-chrome (CoCr) femoral component and a gentamicin-eluting ultra-high molecular weight polyethylene (UHMWPE) tibial insert, which can provide therapeutic delivery of gentamicin, while retaining excellent mechanical properties. The proposed implant is designed to replace conventional spacers made from bone cement. Gentamicin-loaded UHMWPE was prepared using phase-separated compression moulding, and its drug elution kinetics, antibacterial, mechanical, and wear properties were compared with those of conventional gentamicin-loaded bone cement.Aims
Methods
Femoral revision component subsidence has been identified as predicting early failure in revision hip surgery. This comparative cohort study assessed the potential risk factors of subsidence in two commonly used femoral implant designs. A comparative cohort study was undertaken, analyzing a consecutive series of patients following revision total hip arthroplasties using either a tapered-modular (TM) fluted titanium or a porous-coated cylindrical modular (PCM) titanium femoral component, between April 2006 and May 2018. Clinical and radiological assessment was compared for both treatment cohorts. Risk factors for subsidence were assessed and compared.Aims
Methods
The removal of the cruciate ligaments in total knee arthroplasty (TKA) has been suggested as a potential contributing factor to patient dissatisfaction, due to alteration of the in vivo biomechanics of the knee. Bicruciate retaining (BCR) TKA allows the preservation of the cruciate ligaments, thus offering the potential to reproduce healthy kinematics. The aim of this study was to compare in vivo kinematics between the operated and contralateral knee in patients who have undergone TKA with a contemporary BCR design. A total of 29 patients who underwent unilateral BCR TKA were evaluated during single-leg deep lunges and sit-to-stand tests using a validated computer tomography and fluoroscopic imaging system. In vivo six-degrees of freedom (6DOF) kinematics were compared between the BCR TKA and the contralateral knee.Aims
Methods
Satisfactory selection criteria are essential for the successful outcome of unicompartmental knee arthroplasty (UCA). We report the frequency of revision of the Oxford medial unicompartmental arthroplasty in knees previously treated for anteromedial osteoarthritis by high tibial osteotomy (HTO). The combined results from three sources were used to allow
Direct measurements were made on 2,166 lumbar vertebrae of 433 adult negro and caucasoid skeletons. On
Early implants for total knee replacement were fixed to bone with cement. No firm scientific reason has been given for the introduction of cementless knee replacement and the long-term survivorship of such implants has not shown any advantage over cemented forms. In a randomised, prospective study we have compared cemented and uncemented total knee replacement and report the results of 139 prostheses at five years. Outcome was assessed both clinically by independent examination using the Nottingham knee score and radiologically using the Knee Society scoring system. Independent
From 1970 to 1980 cemented metal-on-plastic total hip replacement was performed on 799 hips with primary osteoarthritis using one surgical technique. At the 10- to 20-year follow-up there had been 97 revisions for mechanical loosening. Univariate survivorship analysis showed that an increased risk of revision was associated with male gender, young age at primary THR, the Brunswik and Lubinus snap-fit prostheses with large femoral heads (as compared with the Charnley prosthesis), and varying experience of the surgeon. Multivariate
We have reviewed the long-term results of 22 patients (23 fusions) with fractures of the os calcis, who had subtalar arthrodesis with correction of the deformity between 1975 and 1991. The mean follow-up was nine years (5 to 20). All patients were evaluated according to a modified foot score. A radiological assessment was used in which linear and angular variables were measured including the fibulocalcaneal abutment, the height of the heel and fat pad, the angle of the arch and the lateral talocalcaneal and the lateral talar declination angles. The technique used restores the normal relationship between the hindfoot and midfoot and corrects the height of the heel. This leads to better biomechanical balance of the neighbouring joints and gives a favourable clinical outcome. The modified foot score showed a good or excellent result in 51% of the feet. Residual complaints were mostly due to problems with the soft tissues. Subjectively, an excellent or good score was achieved in 78% of the cases. After
The aim of the current study was to assess the reliability of the Ottawa classification for symptomatic acetabular dysplasia. In all, 134 consecutive hips that underwent periacetabular osteotomy were categorized using a validated software (Hip2Norm) into four categories of normal, lateral/global, anterior, or posterior. A total of 74 cases were selected for reliability analysis, and these included 44 dysplastic and 30 normal hips. A group of six blinded fellowship-trained raters, provided with the classification system, looked at these radiographs at two separate timepoints to classify the hips using standard radiological measurements. Thereafter, a consensus meeting was held where a modified flow diagram was devised, before a third reading by four raters using a separate set of 74 radiographs took place.Aims
Methods
The purpose of this study was to validate our hypothesis that centrifugation may eliminate false-positive leucocyte esterase (LE) strip test results caused by autoimmune diseases in the diagnosis of knee infection. Between January 2016 and May 2019, 83 cases, including 33 cases of septic arthritis and 50 cases of aseptic arthritis, were enrolled in this study. To further validate our hypothesis, another 34 cases of inflammatory arthritis from the Department of Rheumatology of our institution were also included. After aspiration, one drop of synovial fluid was applied to LE strips before and after centrifugation. The results were recorded after approximately three minutes according to the different colour grades on the colour chart. The differences of LE results between each cohort were analyzed.Aims
Methods
Osteoarthritis (OA) is the most prevalent joint disease. However, the specific and definitive genetic mechanisms of OA are still unclear. Tissue-related transcriptome-wide association studies (TWAS) of hip OA and knee OA were performed utilizing the genome-wide association study (GWAS) data of hip OA and knee OA (including 2,396 hospital-diagnosed hip OA patients versus 9,593 controls, and 4,462 hospital-diagnosed knee OA patients versus 17,885 controls) and gene expression reference to skeletal muscle and blood. The OA-associated genes identified by TWAS were further compared with the differentially expressed genes detected by the messenger RNA (mRNA) expression profiles of hip OA and knee OA. Functional enrichment and annotation analysis of identified genes was performed by the DAVID and FUMAGWAS tools.Aims
Methods
We evaluated a large database with mechanical failure of a single uncemented modular femoral component, used in revision hip arthroplasty, as the end point and compared them to a control group treated with the same implant. Patient- and implant-specific risk factors for implant failure were analyzed. All cases of a fractured uncemented modular revision femoral component from one manufacturer until April 2017 were identified and the total number of implants sold until April 2017 was used to calculate the fracture rate. The manufacturer provided data on patient demographics, time to failure, and implant details for all notified fractured devices. Patient- and implant-specific risk factors were evaluated using a logistic regression model with multiple imputations and compared to data from a previously published reference group, where no fractures had been observed. The results of a retrieval analysis of the fractured implants, performed by the manufacturer, were available for evaluation.Aims
Methods
This paper describes the methods applied to assess the cost-effectiveness of cemented versus uncemented hemiarthroplasty among hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial. A within-trial cost-utility analysis (CUA) will be conducted at four months postinjury from a health system (National Health Service and personal social services) perspective. Resource use pertaining to healthcare utilization (i.e. inpatient care, physiotherapy, social care, and home adaptations), and utility measures (quality-adjusted life years) will be collected at one and four months (primary outcome endpoint) postinjury; only treatment of complications will be captured at 12 months. Sensitivity analysis will be conducted to assess the robustness of the results.Aim
Methods
Robotic-assisted total knee arthroplasty (RA-TKA) has been introduced to provide accurate bone cuts and help achieve the target knee alignment, along with symmetric gap balancing. The purpose of this study was to determine if any early clinical benefits could be realized following TKA using robotic-assisted technology. In all, 140 consecutive patients undergoing RA-TKA and 127 consecutive patients undergoing conventional TKA with minimum six-week follow-up were reviewed. Differences in visual analogue scores (VAS) for pain at rest and with activity, postoperative opiate usage, and length of stay (LOS) between the RA-TKA and conventional TKA groups were compared.Aims
Methods
The calcar femorale is a vertical plate of bone lying deep to the lesser trochanter and is formed as a result of traction of the iliopsoas which separates the femoral cortex into two distinct layers, the calcar femorale and the medial femoral cortex. They fuse together proximally to form the medial femoral neck. A stem placed centrally will abut against the calcar femorale with little or no space for cement. Clearing of the calcar will offer space for a cement layer, which will support the stem proximally on the posterior aspect. We compared two consecutive groups of Charnley low-friction arthroplasties, with and without clearing of the calcar. In 330 patients who had an arthroplasty without clearing the calcar, there were ten revisions for aseptic loosening of the stem and six other stems were considered ‘definitely loose’, giving a rate of failure of 4.8%. In 111 patients in whom the calcar was cleared there was only one revision for aseptic loosening and no stems were classed as ‘definitely loose’, giving a rate of failure of 0.9%. Survivorship analysis has again shown the need for long-term follow-up; the differences became clear after ten years but because of the relatively small numbers,