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Completed

NCT Number: NCT00124254

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulvertaft Hand Centre, Derby, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silicone metacarpophalangeal joint arthroplasty

Procedure

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

Other names: Swanson silastic implant

Usual Care

Other

Non-surgical usual care

Primary outcomes

  1. Michigan Hand Outcomes Questionnaire

    Time frame: Baseline, 6 months, 1 year, 2 years, 3 year

Secondary outcomes

  1. Arthritis Impact Measurement Scales Questionnaire

    Time frame: Baseline, 6 months, 1 year, 2 years, 3 years

  2. Standard, objective hand function tests

    Time frame: Baseline, 6 months, 1 year, 2 years, 3 years

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

An Outcome Study of Rheumatoid Hand Arthroplasty

Important dates

Study start
2003
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2005
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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