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Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand
This study is ongoing, but not recruiting participants.
First Received: July 25, 2005   Last Updated: March 31, 2009   History of Changes
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00124254
  Purpose

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 Intervention Phase
Arthritis, Rheumatoid
Procedure: Silicone metacarpophalangeal joint arthroplasty
Other: Usual care
Phase IV

MedlinePlus related topics: Rheumatoid Arthritis Surgery
Drug Information available for: Baysilon Silicone Polydimethylsiloxane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title: An Outcome Study of Rheumatoid Hand Arthroplasty

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Michigan Hand Outcomes Questionnaire [ Time Frame: Baseline, 6 months, 1 year, 2 years, 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arthritis Impact Measurement Scales Questionnaire [ Time Frame: Baseline, 6 months, 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Standard, objective hand function tests [ Time Frame: Baseline, 6 months, 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2003
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Surgical group undergoing SMPA
Procedure: Silicone metacarpophalangeal joint arthroplasty
Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
2: Active Comparator
Nosurgical group
Other: Usual care
Non-surgical usual care

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124254

Locations
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
Investigators
Principal Investigator: Kevin C. Chung, MD, MS University of Michigan
  More Information

Additional Information:
Publications:
Responsible Party: University of Michigan Health System ( Kevin C. Chung )
Study ID Numbers: R01 AR047328, 1-R01-AR047328-01A2
Study First Received: July 25, 2005
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00124254     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Metacarpophalangeal Joint
Arthroplasty
Outcomes
Michigan Hand Outcomes Questionnaire
Joint Replacement

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

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

ClinicalTrials.gov processed this record on May 06, 2009