Status:
COMPLETED
Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
A procedure called silicone metacarpophalangeal joint arthroplasty (SMPA) is sometimes used to treat knuckle deformity in the hands of rheumatoid arthritis (RA) patients. The purpose of this study is ...
Detailed Description
The purpose of this study is to provide a better understanding of the effectiveness of SMPA, a procedure to correct knuckle deformity in the hands of rheumatoid arthritis patients. This study will exa...
Eligibility Criteria
Inclusion
- Diagnosis of rheumatoid arthritis based on the diagnostic criteria of the American Rheumatology Association
- Able to complete questionnaires in English
- Sum of average metacarpophalangeal joint ulnar drift AND average metacarpophalangeal joint extensor lag of 50 degrees or greater
Exclusion
- Severe medical condition precluding surgery
- Concomitant extensor tendon ruptures and metacarpophalangeal joint disease
- Other joint injury of the hand (e.g., swan-neck deformity, boutonniere deformity) requiring surgery
- Previous metacarpophalangeal joint replacement on their study hand
- Disease modifying antirheumatic drugs (DMARDs) within the 3 months prior to study entry
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00124254
Start Date
September 1 2003
End Date
August 1 2017
Last Update
August 22 2017
Active Locations (3)
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1
Curtis National Hand Center
Baltimore, Maryland, United States, 21218
2
University of Michigan
Ann Arbor, Michigan, United States, 48109-0340
3
Pulvertaft Hand Centre
Derby, United Kingdom