A procedure called Swanson 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 have SMPA to RA patients who do not undergo surgery.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Procedure: Swanson metacarpophalangeal joint arthroplasty	Phase IV

Further Study Details: 

Expected Total Enrollment:  200

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. Our research question asks 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 parents. 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 non-surgical 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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00124254

Kevin C. Chung, MD, MS      734-936-5885    kecchung@med.umich.edu
Sandra V. Kotsis, MPH      734-615-6550    sspilson@med.umich.edu

Maryland
      Curtis National Hand Center, Baltimore,  Maryland,  21218,  United States; Recruiting
Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109-0340,  United States; Recruiting
United Kingdom
      Pulvertaft Hand Centre, Derby,  United Kingdom; Recruiting

Study chairs or principal investigators

Kevin C. Chung, MD, MS,  Principal Investigator,  University of Michigan   

Study ID Numbers:  1-R01-AR047328-01A2
Last Updated:  August 1, 2005
Record first received:  July 26, 2005
ClinicalTrials.gov Identifier:  NCT00124254
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02