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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LRTI | Active Comparator | 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. |
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| Suture fixation system | Experimental | CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system. |
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| Suture fixation system + 2 week immobilization | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligament reconstruction with suture fixation system | Procedure | CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Overall Functionality | 6 wks | |
| Overall Functionality | 3 mos | |
| Overall Functionality | 6 mos | |
| Overall Functionality | 12 months | |
| Overall Functionality | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Strength measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Shuler, MD | Athens Orthopedic Clinic, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens Orthopedic Clinic | Athens | Georgia | 30606 | United States |
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| Ligament Reconstruction with Tendon Interposition (LRTI) | Procedure | commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist. |
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| Ligament reconstruction with suture fixation system | Procedure | CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system, with a decreased period of immobilization from 6 weeks to 2 weeks. |
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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 |
| 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 |
| Operative time | Operative time in minutes | Baseline, 6 wks, 3 mos, 6 mos, 12 mos, 24 mos |
| 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 |