To systematically review medical and surgical foot intervention studies in rheumatoid arthritis (RA), focusing on clinical efficacy, study quality, and risk of harm.
We searched appropriate databases using a combination of the terms "rheumatoid arthritis" and "foot" against terms indicating treatment; we also hand-searched references. We selected articles in English (1968-2003) comprising randomized controlled trials (RCTs), controlled clinical trials (CCTs), prospective observational studies, and large retrospective observational surgical studies (> 50 cases). RCT quality was examined using Jadad scoring; other designs were assessed qualitatively.
Inclusion criteria were met by 33 of 894 identified studies, comprising 5 RCTs and 1 CCT (all nonsurgical), 15 prospective observational studies (8 nonsurgical, 7 surgical), and 12 large retrospective studies (all surgical). Functional, custom-designed and semirigid orthoses and extra-depth shoes were effective in single RCTs of variable quality; no comparative studies have been conducted. This finding was supported by a CCT and prospective observational studies. There was no evidence of harm. There were no controlled trials of surgery. Prospective observational studies suggest that forefoot arthroplasty and first metatarsophalangeal joint implants, but not plantar callous debridement, are effective. Comparative retrospective analyses suggest that some procedure variants may be better, and surgery may relieve pain better than orthoses. Infection was the main risk.
RCT evidence shows that orthoses and special shoes are likely to be beneficial in patients with RA. The only evidence of benefit from surgery comes from observational studies, because no RCTs have been conducted. Further RCT evidence is needed, although well-designed observational studies may be helpful.