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

An Outcome Study of Rheumatoid Hand Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00124254
Enrollment
170
Registered
2005-07-27
Start date
2003-09-30
Completion date
2017-08-31
Last updated
2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Metacarpophalangeal Joint, Arthroplasty, Outcomes, Michigan Hand Outcomes Questionnaire, Joint Replacement

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.

Interventions

PROCEDURESilicone metacarpophalangeal joint arthroplasty

Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.

OTHERUsual care

Non-surgical usual care

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Michigan Hand Outcomes QuestionnaireBaseline, 6 months, 1 year, 2 years, 3 year

Secondary

MeasureTime frame
Arthritis Impact Measurement Scales QuestionnaireBaseline, 6 months, 1 year, 2 years, 3 years
Standard, objective hand function testsBaseline, 6 months, 1 year, 2 years, 3 years

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026