Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial
— LRTIOfficial title:
Postoperative Rehabilitation Following Trapeziectomy and Ligament Reconstruction Tendon Interposition: a Prospective, Randomized Multi-center Study
NCT number | NCT01425034 |
Other study ID # | 49860 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2011 |
Est. completion date | February 2019 |
Verified date | August 2019 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Carpometacarpal (CMC) arthritis of the thumb joint ('basal arthritis') is a common entity treated by hand surgeons in our society. It can be a significant source of functional disability secondary to a painful, and often weak, grip. Once patients have failed treatment by conservative means, such as splinting, anti-inflammatories, and cortisone injections, the next option is surgical management. Several surgical options are available depending on the severity of the disease. For the early stages of arthritis options include a ligament reconstruction or a metacarpal extension osteotomy. For advanced stages, only salvage procedures exist. These have included simple trapeziectomy, arthrodesis and implant arthroplasty. The most common procedure, however, has been a trapeziectomy with a ligament reconstruction tendon interposition
Status | Completed |
Enrollment | 234 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients over 40 years old with basal arthritis who failed conservative treatment - Patients receiving LRTI by one of three enrolled surgeons at the U or one of the two enrolled surgeons at Intermountain who consented to the study Exclusion Criteria: - Patients undergoing more procedures in addition to the LRTI that may alter the postoperative course, not including CTR or thumb MCP capsulodesis, MP fusion, trigger finger release - h/o CRPS - RA - Revision LRTI |
Country | Name | City | State |
---|---|---|---|
United States | InterMountain Health Care-TOSH orthopedic center | Murray | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | compare early motion vs. delayed motion after ligament reconstruction tendon interposition for thumb basal arthritis (LRTI) | DASH, VAS for pain, VAS for satisfaction, pinch and grip strength, coordination test and range of motion (thumb opposition) | 2 years |
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