Introduction. External fixators are common surgical orthopaedic treatments for the management of complex fractures and in particular, the use of circular frame fixation within patients requiring limb reconstruction. It is well known that common complications relating to muscle length and patient function without rehabilitation can occur. Despite this there remains a lack of high-quality clinical trials in this area investigating the role of physiotherapy or rehabilitation in the management of these patients. We aim to complete a systematic review of rehabilitation techniques for patients undergoing external fixator treatment for Limb Reconstruction of the lower limb. Materials & Methods. A comprehensive search of AMED, CINAHL, MEDLINE and COCHRANE databases was conducted to identify relevant articles for inclusion, using a search strategy developed in collaboration with a research librarian. Inclusion criteria consisted of adults aged 18 years and over who have experienced leg trauma (open fracture, soft tissue damage), elective leg deformity corrective surgery, bone infection or fracture non-union who have been treated with the use of an external fixator for fixation. Specific exclusion criteria were patients below the age of 18 years old, patients with cancer, treatment of the injury with internal nail, patients who underwent amputation, the use of external fixators for soft tissue contracture management, editorials, comment papers, review papers, conference proceedings and non-English papers. Titles, abstracts, and full texts were screened for suitability by pairs of reviewers according to the inclusion and exclusion criteria using Rayyan QCRI online software. Any conflicts were resolved through discussion with three independent specialist senior reviewers. Following full text screening, references lists of included articles were manually searched to ensure that all relevant studies were identified. Due to lack of evidence, forward searching was also completed for studies included in the review.
Given the low prevalence of sarcoma, international cooperation is necessary to recruit sufficient numbers of patients for surgical trials. The PARITY (Prophylactic Antibiotic Regimens in Tumour Surgery) trial is the first international multicentre trial in orthopedic oncology and successfully achieved target enrollment of 600 patients across 12 countries. It is important to reflect upon the challenges encountered and experiences gained to inform future trials. The objective of this study is to describe recruitment patterns and examine the differences in enrollment across different PARITY sites and identify variables associated with varying levels of recruitment. Data from this study was obtained from the PARITY trial Methods Centre and correspondence data. We performed descriptive statistics to demonstrate the recruitment patterns over time. We compared recruitment, time to set up, and time to enroll the first patient between North American and international sites, and sites that had dedicated research personnel. Two-tailed non-paired t-tests were performed to compare average monthly recruitment rates between groups with significance being set at alpha=0.05. A total of 600 patients from 48 clinical sites and 12 countries were recruited from January 2013 through to October 2019. Average monthly enrollment increased every year of the study. There were 36 North American and 12 international sites. North American sites were able to set up significantly faster than international sites (19.3 vs. 28.3 months p=0.037). However, international sites had a significantly higher recruitment rate per month once active (0.2/month vs. 0.62/month, p=0.018). Of active sites, 40 (83%) had research support personnel and 8 (17%) sites did not. Sites with research personnel were able to reach ‘enrolment ready’ status significantly faster than sites without research support (19.6 vs. 30.7 months, p=0.032). However, there was no significant difference in recruitment rate per month once the sites began enrolling (0.28/month vs. 0.2/month, p=0.63). Trial sites that took longer than 1 year to recruit their first patient had 3x lower average recruitment rate compared to sites that were able to recruit their first patient within a year of being enrolment ready. The PARITY trial is the first multicentre RCT in orthopaedic oncology. The PARITY investigators were able to increase the recruitment levels throughout the trial and generally avoid trial fatigue. This was a North American based trial which may explain the longer start up times internationally given the different regulatory bodies associated with drug-related trials. However, international sites should be considered critical as they were able to recruit significantly more patients per month once active. The absence of research support personnel should not preclude a site from inclusion. These sites took longer to setup but had no difference in monthly recruitment once active. This study will create a framework for identifying and targeting high yield sites for future randomized control trials within orthopaedic oncology to maximum recruitment and resource allocation.
Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach. A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications.Aims
Methods
Radial head fractures are relatively common, representing approximately one-third of all elbow fractures. Outcomes are generally inversely proportional to the amount of force involved in the mechanism of injury, with simple fractures doing better than more comminuted ones. However, the prognosis for these fractures may also be influenced by associated injuries and patient-related factors (age, body index mass, gender, tobacco habit, etc.) The purpose of this study is to evaluate which factors will affect range of motion and function in partial radial head fractures. The hypothesis is that conservative treatment yields better outcomes. This retrospective comparative cohort study included 43 adult volunteers with partial radial head fracture, a minimum one-year follow up, separated into a surgical and non-surgical group. Risk factors were: associated injury, heterotopic ossification, worker's compensation, and proximal radio-ulnar joint implication. Outcomes included radiographic range of motion measurement, demographic
Orthopaedic surgeries are complex, frequently performed procedures associated with significant haemorrhage and perioperative blood transfusion. Given refinements in surgical techniques and changes to transfusion practices, we aim to describe contemporary transfusion practices in orthopaedic surgery in order to inform perioperative planning and blood banking requirements. We performed a retrospective cohort study of adult patients who underwent orthopaedic surgery at four Canadian hospitals between 2014 and 2016. We studied all patients admitted to hospital for nonarthroscopic joint surgeries, amputations, and fracture surgeries. For each surgery and surgical subgroup, we characterized the proportion of patients who received red blood cell (RBC) transfusion, the mean/median number of RBC units transfused, and exposure to platelets and plasma.Aims
Methods
Introduction. The need for the stringent surveillance of new devices was recognised by the NICE review of hip replacement surgery in 2000 and led to the Orthopaedic Data Evaluation Panel (ODEP) developing criteria for post-marketing surveillance (PMS) studies. This requirement has been reinforced by the recent recall of ASR devices. Methods. The South West London Elective Orthopaedic Centre's (EOC's) comprehensive outcomes programme has been adapted to manage and coordinate multi-centre, multi-surgeon, PMS studies. The system allows any schedule and combination of patient-reported outcome measures (PROMS), clinical and radiological assessments, and complications to be collected. Typically, PROMS are collected pre-operatively and yearly by post. Baseline clinical assessment is undertaken pre-operatively, with baseline radiological assessments pre- and post-operatively. Subsequent clinical and radiological assessments are usually obtained at the ODEP-mandated time points of 3, 5, 7 and 10 years post-operatively. Patients are telephoned twice yearly to document complications and any impending change of address. Results. EOC co-ordinated studies extend the ODEP criteria to provide high quality evidence on implant survivorship and patient outcome. In one study, over 500 subjects are under review. The operations were undertaken by twelve surgeons, at three centres. At 3 years participant withdrawal is 4%, mortality 4%, loss to follow-up 1% and revisions 0.5%. Average annual return of PROMS is 94%, and the percentage of invited patients returning for a 3 year review is 81%. Discussion. The EOC system provides a cost-effective method for the long-term follow-up of implants through multi-site, multi-surgeon national, and international, PMS studies. Participation by high-volume centres facilitates both rapid recruitment of study participants and the infrastructure required to maintain consistent
Most long-term follow-up studies report retrospective
Surgeons need to be able to measure angles and distances in three dimensions in the planning and assessment of knee replacement. Computed tomography (CT) offers the accuracy needed but involves greater radiation exposure to patients than traditional long-leg standing radiographs, which give very little information outside the plane of the image. There is considerable variation in CT radiation doses between research centres, scanning protocols and individual scanners, and ethics committees are rightly demanding more consistency in this area. By refining the CT scanning protocol we have reduced the effective radiation dose received by the patient down to the equivalent of one long-leg standing radiograph. Because of this, it will be more acceptable to obtain the three-dimensional data set produced by CT scanning. Surgeons will be able to document the impact of implant position on outcome with greater precision.