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
We report the incidence and intensity of persistent
pain in patients with an otherwise uncomplicated total ankle replacement
(TAR). Arthroscopic debridement was performed in selected cases
and the clinical outcome was analysed. Among 120 uncomplicated TARs, there was persistent pain with
a mean visual analogue scale (VAS) of 2.7 (0 to 8). The intensity
of pain decreased in 115 ankles (95.8%). Exercise or walking for
more than 30 minutes was the most common aggravating factor (62
ankles, 68.1%). The character of the pain was most commonly described
as dull (50 ankles, 54.9%) and located on the medial aspect of the
joint (43 ankles, 47.3%). A total of seven ankles (5.8%) underwent subsequent arthroscopy.
These patients had local symptoms and a VAS for pain ≥ 7 on exertion.
Impingement with fibrosis and synovitis was confirmed. After debridement,
the median VAS decreased from 7 to 3 and six patients were satisfied.
The median VAS for pain and the American Orthopaedic Foot and Ankle
Society score of the ankles after debridement was similar to that
of the uncomplicated TARs (p = 0.496 and p = 0.066, respectively). Although TAR reduces the intensity of pain, residual pain is
not infrequent even in otherwise uncomplicated TARs and soft-tissue
impingement is the possible cause. Cite this article:
