Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Silicone metacarpophalangeal joint arthroplasty; Usual care
Intervention type(s): Procedure; Other
Intervention description(s): Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.; Non-surgical usual care
Other intervention name(s): Swanson silastic implant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metacarpophalangeal Joint; Arthroplasty; Outcomes; Michigan Hand Outcomes Questionnaire; Joint Replacement