Arthritis, Rheumatoid Clinical Trial
Official title:
An Outcome Study of Rheumatoid Hand Arthroplasty
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.
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.
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