Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124254
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2005-07-25
Brief Title:
Study of People With Rheumatoid Arthritis Who Require Joint Surgery in the Hand
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
An Outcome Study of Rheumatoid Hand Arthroplasty
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 21 million Americans and costs the United States an estimated 87 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
RA affects 21 million Americans and costs the United States an estimated 87 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AR047328-01A2 | NIH | None | httpsreporternihgovquickSearch1R01AR047328-01A2 |
| R01AR047328 | NIH | None | None |