Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty
- Conditions
- Thumb Carpometacarpal Arthritis
- Interventions
- Procedure: Ligament reconstruction with suture fixation systemProcedure: Ligament Reconstruction with Tendon Interposition (LRTI)
- Registration Number
- NCT01121874
- Lead Sponsor
- J&M Shuler
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- Male or female patients aged >18.
- Eaton Stage III or IV CMC arthritis
- Failure to respond to conservative treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Suture fixation system Ligament reconstruction with suture fixation system CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system. Suture fixation system + 2 week immobilization Ligament reconstruction with suture fixation system CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system, and with a decreased immobilization time from 6 to 2 weeks post-surgery. LRTI Ligament Reconstruction with Tendon Interposition (LRTI) These patients will undergo ligament reconstruction with tendon interposition (LRTI) surgery. They will serve as a control group, against which to compare the investigational surgical technique.
- Primary Outcome Measures
Name Time Method Overall functionality Baseline 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).
Overall Functionality 24 months
- Secondary Outcome Measures
Name Time Method Analog pain scale Baseline, 2 wks, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos 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.
Strength measures Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos Strength will be assessed via key and tip pinch strength and grip strength, using a dynamometer
Range of motion Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos Range of motion (ROM) will be assessed via radial and palmar abduction (degrees) and opposition (cm).
Scaphometacarpal distance Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos Distance between the distal pole of the scaphoid and the proximal aticular surface of the metacarpal. Taken in stressed and relaxed views
Operative time Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos Operative time in minutes
Trial Locations
- Locations (1)
Athens Orthopedic Clinic
🇺🇸Athens, Georgia, United States