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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Kevin C. Chung, University of Michigan
ClinicalTrials.gov Identifier:
NCT00124254
First received: July 25, 2005
Last updated: January 25, 2013
Last verified: January 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Outcome Study of Rheumatoid Hand Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Kevin C. Chung, Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT00124254     History of Changes
Other Study ID Numbers: R01 AR047328, R01AR047328, 1-R01-AR047328-01A2
Study First Received: July 25, 2005
Last Updated: January 25, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Metacarpophalangeal Joint
Arthroplasty
Outcomes
Michigan Hand Outcomes Questionnaire
Joint Replacement

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

ClinicalTrials.gov processed this record on October 19, 2014