Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand

Not Applicable

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Other: Usual care; Procedure: Silicone metacarpophalangeal joint arthroplasty

• Registration Number: NCT00124254
• Lead Sponsor: University of Michigan

Brief 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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-07-25
• Study First Submitted QC: 2005-07-25
• Study First Posted: 2005-07-27
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Usual care	Nosurgical group
1	Silicone metacarpophalangeal joint arthroplasty	Surgical group undergoing SMPA

Primary Outcome Measures

Name	Time	Method
Michigan Hand Outcomes Questionnaire	Baseline, 6 months, 1 year, 2 years, 3 year

Secondary Outcome Measures

Name	Time	Method
Arthritis Impact Measurement Scales Questionnaire	Baseline, 6 months, 1 year, 2 years, 3 years
Standard, objective hand function tests	Baseline, 6 months, 1 year, 2 years, 3 years

Trial Locations

Locations (3)

Curtis National Hand Center; 🇺🇸 Baltimore, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Pulvertaft Hand Centre; 🇬🇧 Derby, United Kingdom