Arthritis, Rheumatoid Clinical Trial
Official title:
An Outcome Study of Rheumatoid Hand Arthroplasty
Verified date | August 2017 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Pulvertaft Hand Centre | Derby | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Curtis National Hand Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States, United Kingdom,
Chetta M, Burns PB, Kim HM, Burke FD, Wilgis EF, 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. — View Citation
Chung KC, Burke FD, Wilgis EF, 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):1769-77. doi: 10.1097/PRS.0b013e3181a65b5a. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. 20 — View Citation
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):1507-14. doi: 10.1097/PRS.0000000000002083. — View Citation
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. — View Citation
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-81e. doi: 10.1097/PRS.0000000000001778. — View Citation
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):305-14. doi: 10.1097/PRS.0000000000001409. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Michigan Hand Outcomes Questionnaire | Baseline, 6 months, 1 year, 2 years, 3 year | ||
Secondary | Arthritis Impact Measurement Scales Questionnaire | Baseline, 6 months, 1 year, 2 years, 3 years | ||
Secondary | Standard, objective hand function tests | Baseline, 6 months, 1 year, 2 years, 3 years |
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