- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00124254
Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand
An Outcome Study of Rheumatoid Hand Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Derby, United Kingdom
- Pulvertaft Hand Centre
-
-
-
-
Maryland
-
Baltimore, Maryland, United States, 21218
- Curtis National Hand Center
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-0340
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Surgical group undergoing SMPA
|
Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
Other Names:
|
Active Comparator: 2
Nosurgical group
|
Non-surgical usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Michigan Hand Outcomes Questionnaire
Time Frame: Baseline, 6 months, 1 year, 2 years, 3 year
|
Baseline, 6 months, 1 year, 2 years, 3 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arthritis Impact Measurement Scales Questionnaire
Time Frame: Baseline, 6 months, 1 year, 2 years, 3 years
|
Baseline, 6 months, 1 year, 2 years, 3 years
|
Standard, objective hand function tests
Time Frame: Baseline, 6 months, 1 year, 2 years, 3 years
|
Baseline, 6 months, 1 year, 2 years, 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kevin C. Chung, MD, MS, University of Michigan
Publications and helpful links
General Publications
- Mathews AL, Burns PB, Chung KC. How Rheumatoid Arthritis Patients Make Decisions Regarding Hand Reconstruction: A Qualitative Study from the Silicone Arthroplasty in Rheumatoid Arthritis Project. Plast Reconstr Surg. 2016 May;137(5):1507-1514. doi: 10.1097/PRS.0000000000002083.
- Sears ED, Burns PB, Chung KC. Relationship between Patient Expectations and Clinical Measures in Patients Undergoing Rheumatoid Hand Surgery from the Silicone Arthroplasty in Rheumatoid Arthritis (SARA) Study. Plast Reconstr Surg. 2015 Dec;136(6):775e-781e. doi: 10.1097/PRS.0000000000001778.
- Mathews AL, Coleska A, Burns PB, Chung KC. Evolution of Patient Decision-Making Regarding Medical Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Mar;68(3):318-24. doi: 10.1002/acr.22688.
- Squitieri L, Chung KC, Hutton DW, Burns PB, Kim HM, Mahmoudi E. A 5-Year Cost-Effectiveness Analysis of Silicone Metacarpophalangeal Arthroplasty in Patients with Rheumatoid Arthritis. Plast Reconstr Surg. 2015 Aug;136(2):305-314. doi: 10.1097/PRS.0000000000001409.
- Chung KC, Nellans KW, Burns PB, Wilgis EF, Burke FD, Fox DA, Kim HM. Patient expectations and long-term outcomes in rheumatoid arthritis patients: results from the SARA (Silicone Arthroplasty in Rheumatoid Arthritis) study. Clin Rheumatol. 2015 Apr;34(4):641-51. doi: 10.1007/s10067-014-2775-z. Epub 2014 Sep 30.
- Chetta M, Burns PB, Kim HM, Burke FD, Wilgis EFS, Fox DA, Chung KC. The effect of swan neck and boutonniere deformities on the outcome of silicone metacarpophalangeal joint arthroplasty in rheumatoid arthritis. Plast Reconstr Surg. 2013 Sep;132(3):597-603. doi: 10.1097/PRS.0b013e31829ad1c1.
- Chung KC, Burns PB, Kim HM, Burke FD, Wilgis EF, Fox DA. Long-term followup for rheumatoid arthritis patients in a multicenter outcomes study of silicone metacarpophalangeal joint arthroplasty. Arthritis Care Res (Hoboken). 2012 Sep;64(9):1292-300. doi: 10.1002/acr.21705.
- Chung KC, Burns PB, Reichert HA, Fox DA, Burke FD, Wilgis EF, Regan M, Kim HM. Properties of the International Classification for Functioning, Disability and Health in assessing hand outcomes in patients with rheumatoid arthritis. J Rehabil Med. 2011 Mar;43(4):292-8. doi: 10.2340/16501977-0671.
- Waljee JF, Chung KC, Kim HM, Burns PB, Burke FD, Wilgis EF, Fox DA. Validity and responsiveness of the Michigan Hand Questionnaire in patients with rheumatoid arthritis: a multicenter, international study. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1569-77. doi: 10.1002/acr.20274. Epub 2010 Jun 2.
- Chung KC, Kotsis SV, Fox DA, Regan M, Burke FD, Wilgis EF, Kim HM. Differences between the United States and the United Kingdom in the treatment of rheumatoid arthritis: analyses from a hand arthroplasty trial. Clin Rheumatol. 2010 Apr;29(4):363-7. doi: 10.1007/s10067-009-1314-9.
- Chung KC, Kotsis SV, Wilgis EF, Fox DA, Regan M, Kim HM, Burke FD. Outcomes of silicone arthroplasty for rheumatoid metacarpophalangeal joints stratified by fingers. J Hand Surg Am. 2009 Nov;34(9):1647-52. doi: 10.1016/j.jhsa.2009.06.029.
- Chung KC, Burke FD, Wilgis EFS, Regan M, Kim HM, Fox DA. A prospective study comparing outcomes after reconstruction in rheumatoid arthritis patients with severe ulnar drift deformities. Plast Reconstr Surg. 2009 Jun;123(6):1769-1777. doi: 10.1097/PRS.0b013e3181a65b5a.
- Chung KC, Kotsis SV, Kim HM. A prospective outcomes study of Swanson metacarpophalangeal joint arthroplasty for the rheumatoid hand. J Hand Surg Am. 2004 Jul;29(4):646-53. doi: 10.1016/j.jhsa.2004.03.004.
- Chung KC, Kotsis SV, Kim HM, Burke FD, Wilgis EF. Reasons why rheumatoid arthritis patients seek surgical treatment for hand deformities. J Hand Surg Am. 2006 Feb;31(2):289-94. doi: 10.1016/j.jhsa.2005.10.005.
- Mandl LA, Burke FD, Shaw Wilgis EF, Lyman S, Katz JN, Chung KC. Could preoperative preferences and expectations influence surgical decision making? Rheumatoid arthritis patients contemplating metacarpophalangeal joint arthroplasty. Plast Reconstr Surg. 2008 Jan;121(1):175-180. doi: 10.1097/01.prs.0000295376.70930.7e.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AR047328 (U.S. NIH Grant/Contract)
- 1R01AR047328-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis, Rheumatoid
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on Silicone metacarpophalangeal joint arthroplasty
-
Schulthess KlinikCompletedRheumatoid Arthritis - Hand JointSwitzerland
-
Waldfriede HospitalRecruitingOsteoarthritis Metacarpophalangeal Joint | Rheumatoid Arthritis Metacarpophalangeal JointGermany
-
National University of MalaysiaRecruitingTrigger Finger | Stenosing TenosynovitisMalaysia
-
Imperial College LondonUnknownOsteoarthritis | Rheumatoid Arthritis | Septic ArthritisUnited Kingdom
-
Schulthess KlinikTerminatedArthroplasty | Replacement | Finger JointSwitzerland
-
Nicolaus Copernicus UniversityWarmia and Mazury Oncology CentreRecruitingOsteoarthritis, Knee | Osteoarthritis, HipPoland
-
Regional Hospital HolstebroUnknownOsteoarthritisDenmark
-
TeknimedRecruiting
-
Chang Gung Memorial HospitalNot yet recruitingArthritis Knee | Arthritis HipTaiwan
-
University of TartuTartu University Hospital; Estonian Science FoundationCompletedCardiovascular Diseases | Metabolic Syndrome | Osteoarthritis of the Hip | Osteoarthritis of the KneeEstonia