search
Back to results

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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Silicone metacarpophalangeal joint arthroplasty
Usual care
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Metacarpophalangeal Joint, Arthroplasty, Outcomes, Michigan Hand Outcomes Questionnaire, Joint Replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Curtis National Hand Center
  • University of Michigan
  • Pulvertaft Hand Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Surgical group undergoing SMPA

Nosurgical group

Outcomes

Primary Outcome Measures

Michigan Hand Outcomes Questionnaire

Secondary Outcome Measures

Arthritis Impact Measurement Scales Questionnaire
Standard, objective hand function tests

Full Information

First Posted
July 25, 2005
Last Updated
August 21, 2017
Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00124254
Brief Title
Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand
Official Title
An Outcome Study of Rheumatoid Hand Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Metacarpophalangeal Joint, Arthroplasty, Outcomes, Michigan Hand Outcomes Questionnaire, Joint Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Surgical group undergoing SMPA
Arm Title
2
Arm Type
Active Comparator
Arm Description
Nosurgical group
Intervention Type
Procedure
Intervention Name(s)
Silicone metacarpophalangeal joint arthroplasty
Other Intervention Name(s)
Swanson silastic implant
Intervention Description
Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Non-surgical usual care
Primary Outcome Measure Information:
Title
Michigan Hand Outcomes Questionnaire
Time Frame
Baseline, 6 months, 1 year, 2 years, 3 year
Secondary Outcome Measure Information:
Title
Arthritis Impact Measurement Scales Questionnaire
Time Frame
Baseline, 6 months, 1 year, 2 years, 3 years
Title
Standard, objective hand function tests
Time Frame
Baseline, 6 months, 1 year, 2 years, 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin C. Chung, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Curtis National Hand Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0340
Country
United States
Facility Name
Pulvertaft Hand Centre
City
Derby
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26796370
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):1507-1514. doi: 10.1097/PRS.0000000000002083.
Results Reference
background
PubMed Identifier
26595031
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-781e. doi: 10.1097/PRS.0000000000001778.
Results Reference
background
PubMed Identifier
26315611
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.
Results Reference
background
PubMed Identifier
25909303
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):305-314. doi: 10.1097/PRS.0000000000001409.
Results Reference
background
PubMed Identifier
25267562
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.
Results Reference
background
PubMed Identifier
23985634
Citation
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.
Results Reference
background
PubMed Identifier
22511483
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.
Results Reference
background
PubMed Identifier
21267527
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.
Results Reference
background
PubMed Identifier
20521331
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.
Results Reference
background
PubMed Identifier
20077124
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.
Results Reference
background
PubMed Identifier
19896008
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.
Results Reference
background
PubMed Identifier
19483578
Citation
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.
Results Reference
background
PubMed Identifier
15249089
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. doi: 10.1016/j.jhsa.2004.03.004.
Results Reference
result
PubMed Identifier
16473693
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. doi: 10.1016/j.jhsa.2005.10.005.
Results Reference
result
PubMed Identifier
18176218
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. 2008 Jan;121(1):175-180. doi: 10.1097/01.prs.0000295376.70930.7e.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs