Anti-TNFα Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Rheumatoid arthritis (RA) is a frequent inflammatory arthritis that can lead to severe joint deformity and often requires orthopaedic surgical interventions. Anti-Tumor Necrosis Factor α (anti-TNFα) are biological disease-modifying antirheumatic drugs (DMARDs) increasingly used in the treatment of rheumatoid arthritis. An increased risk of opportunistic infection was demonstrated in patients treated with those drugs. This observation led many national committees to recommend anti-TNFα suspension in the perioperative period to avoid a raise in the postoperative infection risk in those patients. This approach is not supported by the data available in the current literature and it exposes patients to an increased risk of inflammatory flare ups of their disease during and after anti-TNFα suspension, which can compromise their postoperative rehabilitation and their quality of life.

The objective of this prospective randomized multicentric trial is to determine the effect of anti-TNFα suspension in the perioperative period on the postoperative infection risk. Overall, 660 rheumatoid arthritis patients requiring an elective foot or ankle surgery will be randomized into two groups. In the first group, anti-TNFα will be stopped 3 half-lives before the surgery while they will be continued in the second group. The postoperative infection rate will be compared between the two groups. Postoperative complication rates, flares and revision surgeries as well as the functional improvement will be compared.

The study hypothesis is that there is no significant difference in the risk of postoperative infection between the two groups.

Results from this study will help determine the optimal way to use anti-TNFα in the perioperative period and will therefore improve the quality of life of rheumatoid arthritis patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec; CHU de Quebec-Universite Laval
• Treatments: Adalimumab; Antibodies, Monoclonal; Certolizumab Pegol; Etanercept; Golimumab; Infliximab

Criteria

Inclusion Criteria:

• Male and female 18 years of age or older

• Rheumatoid arthritis diagnostic according to the American College Rheumatology (ACR) 1987 criteria [38]

• Patient treated with anti-TNFα for at least six months

• Elective unilateral surgery of the foot and ankle

Exclusion Criteria:

• Patient unable to give informed consent

• Surgery on an infected site

• Severe distal peripheral vascular disease (no distal pulse)

• Medical condition contraindicating surgery

• Patient treated with biologic DMARD other than anti-TNFα

• Circumstances preventing an adequate postoperative follow-up

• Revision surgery