Symptomatic treatment of ankle osteoarthritis (OA) with corticosteroid injections is well established. Hyaluronic acid is also reported as an effective symptomatic treatment for ankle OA but these two treatments have not been compared directly. A prospective randomised controlled trial in patients with symptomatic ankle osteoarthritis. Twenty patients per group were required based on a significance level of 0.05, and a drop out rate of 5%. Patients were blindly allocated to the treatment or control group. Injections were carried out by the clinician in the outpatient department. Treatment group received Ostenil 20 mg and control group received Depomedrone 40 mg (both as single injections). The treatment arm was allocated by computer generated block randomization to match treatment allocation with grade of arthritis. The primary outcome measure was the change in Visual Analogue Scale (VAS) pain score at 6 months. Secondary outcome was the change in AOFAS score at 6 months. Research ethics committee approval was obtained.Introduction:
Methods:
Injury to the syndesmosis occurs in approximately 10% of all patients with ankle fractures. Anatomic restoration of the syndesmosis is the only significant predictor of functional outcome. Several techniques of syndesmosis fixation are currently used such as cortical screws, bioabsorbable screws and more recently introduced suture-button fixation. No single technique has been shown to be superior to the others. The objective of this research project is to investigate whether treatment with a tightrope (suture-button fixation) gives superior results than the use of a cortical screw in the treatment of acute syndesmotic ankle injuries with regards to function, pain, satisfaction and return to normal activities. Research Ethics Committee approval was obtained. 40 patients with syndesmotic ankle injuries associated with diastasis were prospectively recruited, 20 in each group. Patients were randomized to one of the 2 groups. At 12 weeks, American Orthopaedic Foot and Ankle Society (AOFAS) scores and a computerized tomography (CT) scan of both the ankles was obtained. At 1 year, AOFAS scores and satisfaction was assessed. 32 patients have been recruited so far, 20 in the tightrope group and 12 in the cortical screw group. Mean AOFAS scores at 3 months post-op were 90.67 in the Tightrope group and 84 in the screw group. The difference was not significant (p= 0.096). CT scans revealed that the quality of syndesmosis reduction was equally good with both the techniques. Metalwork prominence was common with both the devices. Both the devices achieved good reduction of the syndesmosis. Our CT scan protocol has insignificant radiation risk and allows more accurate assessment of the syndesmosis. Early clinical results do not show a significant difference in the functional outcome with the use of either device. Long-term (1 year) follow-up has been planned.Discussion and Conclusion
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
