Status:
UNKNOWN
Anti-TNFα Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis
Lead Sponsor:
CHU de Quebec-Universite Laval
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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) a...
Detailed Description
A. STUDY DESIGN This is a prospective randomized multicentric trial. Patients will be randomized into two groups. Patients in Group A will continue their anti-TNF treatment during the whole perioperat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT02242474
Start Date
July 1 2015
End Date
October 1 2019
Last Update
July 18 2018
Active Locations (1)
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1
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada, G1V 2L9