A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment.Aims
Methods
This is a multicentre, non-inventor, prospective observational study of 503 INFINITY fixed bearing total ankle arthroplasties (TAAs). We report our early experience, complications, and radiological and functional outcomes. Patients were recruited from 11 specialist centres between June 2016 and November 2019. Demographic, radiological, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Questionnaire, and EuroQol five-dimension five-level score) were collected preoperatively, at six months, one year, and two years. The Canadian Orthopaedic Foot and Ankle Society (COFAS) grading system was used to stratify deformity. Early and late complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts, and/or subsidence.Aims
Methods
We performed a systematic review and meta-analysis
of modern total ankle replacements (TARs) to determine the survivorship,
outcome, complications, radiological findings and range of movement,
in patients with end-stage osteoarthritis (OA) of the ankle who
undergo this procedure. We used the methodology of the Cochrane Collaboration,
which uses risk of bias profiling to assess the quality of papers
in favour of a domain-based approach. Continuous outcome scores
were pooled across studies using the generic inverse variance method
and the random-effects model was used to incorporate clinical and
methodological heterogeneity. We included 58 papers (7942 TARs)
with an interobserver reliability (Kappa) for selection, performance,
attrition, detection and reporting bias of between 0.83 and 0.98.
The overall survivorship was 89% at ten years with an annual failure
rate of 1.2% (95% confidence interval (CI) 0.7 to 1.6). The mean
American Orthopaedic Foot and Ankle Society score changed from 40 (95%
CI 36 to 43) pre-operatively to 80 (95% CI 76 to 84) at a mean follow-up
of 8.2 years (7 to 10) (p <
0.01). Radiolucencies were identified
in up to 23% of TARs after a mean of 4.4 years (2.3 to 9.6). The
mean total range of movement improved from 23° (95% CI 19 to 26)
to 34° (95% CI 26 to 41) (p = 0.01). Our study demonstrates that TAR has a positive impact on patients’
lives, with benefits lasting ten years, as judged by improvement
in pain and function, as well as improved gait and increased range
of movement. However, the quality of evidence is weak and fraught
with biases and high quality randomised controlled trials are required
to compare TAR with other forms of treatment such as fusion. Cite this article:
