Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand
|Arthritis, Rheumatoid||Procedure: Silicone metacarpophalangeal joint arthroplasty Other: Usual care||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Outcome Study of Rheumatoid Hand Arthroplasty|
- Michigan Hand Outcomes Questionnaire [ Time Frame: Baseline, 6 months, 1 year, 2 years, 3 year ]
- Arthritis Impact Measurement Scales Questionnaire [ Time Frame: Baseline, 6 months, 1 year, 2 years, 3 years ]
- Standard, objective hand function tests [ Time Frame: Baseline, 6 months, 1 year, 2 years, 3 years ]
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Surgical group undergoing SMPA
Procedure: Silicone metacarpophalangeal joint arthroplasty
Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
Other Name: Swanson silastic implant
Active Comparator: 2
Other: Usual care
Non-surgical usual care
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124254
|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|
|Pulvertaft Hand Centre|
|Derby, United Kingdom|
|Principal Investigator:||Kevin C. Chung, MD, MS||University of Michigan|