Suture Fixation System Versus Tendonous Reconstruction in Carpometacarpal (CMC) Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Suture Fixation System Versus Tendonous Reconstruction in Thumb Carpometacarpal Arthroplasty: a Randomized Controlled Trial

Conditions
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Thumb Carpometacarpal Arthritis

Intervention / Treatment
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* Procedure: Ligament reconstruction with suture fixation system
* Procedure: Ligament Reconstruction with Tendon Interposition (LRTI)
* Procedure: Ligament reconstruction with suture fixation system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LRTI<br>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. | Procedure: Ligament Reconstruction with Tendon Interposition (LRTI)<br>* commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.<br>|
| Experimental: Suture fixation system<br>CMC arthroplasty which reconstructs palmar oblique ligament using a suture fixation system. | Procedure: Ligament reconstruction with suture fixation system<br>* CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system<br>* Other names: Arthrex Mini TightRope;|
| Experimental: Suture fixation system + 2 week immobilization<br>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. | Procedure: Ligament reconstruction with suture fixation system<br>* 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.<br>* Other names: Arthrex Mini TightRope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CMC arthritis, thumb carpometacarpal arthritis, basal joint arthritis, thumb CMC arthritis