Arthritis, RheumatoidNCT00124254
Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand
A study testing Silicone metacarpophalangeal joint arthroplasty in people with Arthritis, Rheumatoid, run by University of Michigan at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Silicone metacarpophalangeal joint arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2003to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109-0340
Curtis National Hand Center
Baltimore, Maryland, 21218
About this study
Official title: An Outcome Study of Rheumatoid Hand Arthroplasty
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.
Read the 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Silicone metacarpophalangeal joint arthroplasty, Usual care
- Keywords
- Metacarpophalangeal Joint, Arthroplasty, Outcomes, Michigan Hand Outcomes Questionnaire, Joint Replacement
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone metacarpophalangeal joint arthroplastyProcedure or surgery
Also called Swanson silastic implant
Intervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant.
Usual careOther
Non-surgical usual care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Surgical group undergoing SMPA Receives: Procedure: Silicone metacarpophalangeal joint arthroplasty |
| 2 | Active comparator | Nosurgical group Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Hand Outcomes Questionnaire
Measured: Baseline, 6 months, 1 year, 2 years, 3 year
Secondary outcomes (2)
Arthritis Impact Measurement Scales Questionnaire
Measured: Baseline, 6 months, 1 year, 2 years, 3 years
Standard, objective hand function tests
Measured: Baseline, 6 months, 1 year, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
- Study startSep 2003
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Dr. Kevin C. Chung, University of Michigan
- Investigators
- Kevin C. Chung, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124254
- Sponsor's protocol ID
- R01AR047328
- Other IDs
- R01AR047328, 1R01AR047328-01A2
- Status last verified
- Aug 2017
- First submitted
- 25 Jul 2005
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26796370Sears 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.
PubMed 26595031Mathews 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.
PubMed 26315611Squitieri 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.
PubMed 25909303Chung 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.
PubMed 25267562Chetta 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.
PubMed 23985634Chung 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.
PubMed 22511483Chung 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.
PubMed 21267527Waljee 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.
PubMed 20521331Chung 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.
PubMed 20077124Chung 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.
PubMed 19896008Chung 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.
PubMed 19483578Chung 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.
PubMed 15249089Chung 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.
PubMed 16473693Mandl 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.
PubMed 18176218
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outcome Study of Rheumatoid Hand Arthroplasty
- ClinicalTrials.gov ID
- NCT00124254
- Acronym / sponsor ID
- R01AR047328
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Metacarpophalangeal Joint, Arthroplasty, Outcomes, Michigan Hand Outcomes Questionnaire, Joint Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 2003
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 27 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Silicone metacarpophalangeal joint arthroplastySurgical group undergoing SMPA |
| 2 | Active comparator | Other: Usual careNosurgical group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone metacarpophalangeal joint arthroplastyAlso: Swanson silastic implantIntervention involves reconstructing the metacarpophalangeal joint using the Swanson silastic implant. | Procedure or surgery | 1 |
| Usual careNon-surgical usual care | Other | 2 |
Primary outcome
Michigan Hand Outcomes Questionnaire
Time frame: Baseline, 6 months, 1 year, 2 years, 3 year
2 secondary outcomes
Arthritis Impact Measurement Scales Questionnaire
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Background: PubMed 26796370Mathews 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.
- Background: PubMed 26595031Sears 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.
- Background: PubMed 26315611Mathews 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.
- Background: PubMed 25909303Squitieri 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.
- Background: PubMed 25267562Chung 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.
- Background: PubMed 23985634Chetta 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.
- Background: PubMed 22511483Chung 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.
- Background: PubMed 21267527Chung 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.
- Background: PubMed 20521331Waljee 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.
- Background: PubMed 20077124Chung 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.
- Background: PubMed 19896008Chung 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.
- Background: PubMed 19483578Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin C. Chung, MD, MS principal investigator
University of Michigan
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone metacarpophalangeal joint arthroplasty in people with Arthritis, Rheumatoid, run by University of Michigan at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Michigan Hand Outcomes Questionnaire (time frame: Baseline, 6 months, 1 year, 2 years, 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124254, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.