Thumb Carpometacarpal Arthritis Clinical Trial
Official title:
Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial
| NCT number | NCT01121874 |
| Other study ID # | CMC-101 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 12, 2010 |
| Est. completion date | July 25, 2012 |
| Verified date | August 2018 |
| Source | J&M Shuler |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who
fail to respond to conservative treatment may benefit from surgery; however, controversy
exists over the most effective surgical technique. A popular technique, ligament
reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by
reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist.
We believe that use of a suture fixation system to reconstruct the palmar oblique ligament,
instead of harvesting a wrist tendon, may provide a superior repair. The objective of this
study is to compare functional outcome measurements among patients who receive CMC
arthroplasty using a suture fixation system (investigational group) to those who receive LRTI
surgery (control group). We hypothesize that patients in the investigational group will
demonstrate superior functionality, compared to patients in the control group.
| Status | Completed |
| Enrollment | 53 |
| Est. completion date | July 25, 2012 |
| Est. primary completion date | May 21, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Male or female patients aged >18. - Eaton Stage III or IV CMC arthritis - Failure to respond to conservative treatment Exclusion Criteria: - Previous surgical interventions on that thumb - Upper extremity neurological dysfunction - Inability to effectively communicate with the research staff, due to hearing impairment, cognitive impairment, or a language barrier - Unwilling or unable to provide written informed consent |
| Country | Name | City | State |
|---|---|---|---|
| United States | Athens Orthopedic Clinic | Athens | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| J&M Shuler |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall functionality | Functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which assesses functionality of the upper extremity, and Short Form 36 (SF-36) health outcomes assessment, which quantifies global functionality (not specific to the upper extremity). | Baseline | |
| Primary | Overall Functionality | 6 wks | ||
| Primary | Overall Functionality | 3 mos | ||
| Primary | Overall Functionality | 6 mos | ||
| Primary | Overall Functionality | 12 months | ||
| Primary | Overall Functionality | 24 months | ||
| Secondary | Analog pain scale | Pain will be assessed using the visual analog pain scale, which asks the patient to rate their pain on a scale from 1 to 10. | Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos | |
| Secondary | Strength measures | Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer | Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos | |
| Secondary | Range of motion | Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm). | Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos | |
| Secondary | Operative time | Operative time in minutes | Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos | |
| Secondary | Scaphometacarpal distance | Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views | Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos |