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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00124254
Recruitment Status : Completed
First Posted : July 27, 2005
Last Update Posted : August 22, 2017
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Dr. Kevin C. Chung, 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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Procedure: Silicone metacarpophalangeal joint arthroplasty Other: Usual care Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Outcome Study of Rheumatoid Hand Arthroplasty
Study Start Date : September 2003
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Surgical group undergoing SMPA
Procedure: Silicone metacarpophalangeal joint arthroplasty
Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
Other Name: Swanson silastic implant
Active Comparator: 2
Nosurgical group
Other: Usual care
Non-surgical usual care

Primary Outcome Measures :
  1. Michigan Hand Outcomes Questionnaire [ Time Frame: Baseline, 6 months, 1 year, 2 years, 3 year ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00124254

United States, Maryland
Curtis National Hand Center
Baltimore, Maryland, United States, 21218
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0340
United Kingdom
Pulvertaft Hand Centre
Derby, United Kingdom
Sponsors and Collaborators
University of Michigan
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Kevin C. Chung, MD, MS University of Michigan

Additional Information:
Publications of Results:
Other Publications:

Responsible Party: Dr. Kevin C. Chung, Professor of Surgery, University of Michigan Identifier: NCT00124254     History of Changes
Other Study ID Numbers: R01AR047328 ( U.S. NIH Grant/Contract )
1R01AR047328-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2005    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Dr. Kevin C. Chung, University of Michigan:
Metacarpophalangeal Joint
Michigan Hand Outcomes Questionnaire
Joint Replacement

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases