Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand

Study Overview
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Brief Summary
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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 to compare the health outcomes of RA patients who choose to undergo SMPA surgery to RA patients who do not undergo surgery.

Detailed Description
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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 examine whether rheumatoid arthritis patients who undergo SMPA will have better outcomes than those patients who do not have this surgery. RA affects 2.1 million Americans and costs the United States an estimated $8.7 billion annually in medical costs and wages. RA is a progressive disease, and approximately 25% of RA patients experience hand deformities associated with the destruction of the metacarpophalangeal (MCP) joints. For the past 30 years, SMPA has been performed on such patients to correct metacarpophalangeal joint deformity in the rheumatoid hand. SMPA can provide pain relief, restoration of function, and aesthetic improvement to the patient. However, because data are limited on its efficacy, SMPA remains a controversial procedure. Hand surgeons and rheumatologists frequently disagree about the indications for this procedure and its value to their patients. In addition, most published studies have been hampered by inadequate consideration of research design, small sample size, and inconsistent outcome measures. The purpose of this study is to measure short- and long-term outcomes following SMPA. The study will also define indications of the surgery for specific patient groups and disease severity. The experiences of both surgery and rheumatology services will be used to jointly evaluate this surgical procedure. This study is a multicenter, international outcomes study to evaluate RA patients with severe MCP joint problems. Patients will choose to be enrolled into a surgical group undergoing SMPA or a nonsurgical group. Patients will be evaluated at Month 6 and annually until the third year. Patient evaluations will be based on the Michigan Hand Outcomes Questionnaire, the Arthritis Impact Measurement Scales questionnaire, and standard, objective hand function tests.

Official Title
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An Outcome Study of Rheumatoid Hand Arthroplasty

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Procedure: Silicone metacarpophalangeal joint arthroplasty
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Surgical group undergoing SMPA | Procedure: Silicone metacarpophalangeal joint arthroplasty<br>* Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.<br>* Other names: Swanson silastic implant;|
| Active Comparator: 2<br>Nosurgical group | Other: Usual care<br>* Non-surgical usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Michigan Hand Outcomes Questionnaire |  | Baseline, 6 months, 1 year, 2 years, 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis Impact Measurement Scales Questionnaire |  | Baseline, 6 months, 1 year, 2 years, 3 years | 
| Standard, objective hand function tests |  | Baseline, 6 months, 1 year, 2 years, 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metacarpophalangeal Joint, Arthroplasty, Outcomes, Michigan Hand Outcomes Questionnaire, Joint Replacement