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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00124254 |
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.
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Procedure: Silicone metacarpophalangeal joint arthroplasty Other: Usual care |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | An Outcome Study of Rheumatoid Hand Arthroplasty |
Estimated Enrollment: | 200 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Surgical group undergoing SMPA
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Procedure: Silicone metacarpophalangeal joint arthroplasty
Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
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2: Active Comparator
Nosurgical group
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Other: Usual care
Non-surgical usual care
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Curtis National Hand Center | |
Baltimore, Maryland, United States, 21218 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109-0340 | |
United Kingdom | |
Pulvertaft Hand Centre | |
Derby, United Kingdom |
Principal Investigator: | Kevin C. Chung, MD, MS | University of Michigan |
Responsible Party: | University of Michigan Health System ( Kevin C. Chung ) |
Study ID Numbers: | R01 AR047328, 1-R01-AR047328-01A2 |
Study First Received: | July 25, 2005 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00124254 History of Changes |
Health Authority: | United States: Federal Government |
Metacarpophalangeal Joint Arthroplasty Outcomes Michigan Hand Outcomes Questionnaire Joint Replacement |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |