A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) With an Interference Screw for Thumb Carpometacarpal Arthritis - Pilot Study

Study Overview
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Brief Summary
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A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) with an interference screw for thumb carpometacarpal arthritis

Detailed Description
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This study will be a prospective randomized trial done in a single academic center. The patients who meet the inclusion criteria and agree to participate in the trial will be scheduled for a first CMC joint procedure. The procedure, standard LRTI or LRTI with a biotenodesis screw, will be allocated in a randomized fashion in the operating room using a sealed opaque envelope. After the surgery the patient will be placed in a spica splint for 1-2 weeks. Following suture removal, a thumb spica cast will be applied for immobilization for a total of 6 weeks of post-operative immobilisation. The potential population for this study will include all patients with first carpometacarpal joint arthritis that have failed a conservative treatment. The primary outcome will be the thumb subsidence measured as the percentage of trapezial height, which correlates with stability. Subsidence will be measured on stress x-ray under a standard pinch load. Secondary outcomes will be function measured in 4 different ways: the range of motion compared to the contralateral side, pinch and grip strength compared to the other side, the Disabilities of the Arm Shoulder and Hand (DASH) score and the pain score on a visual analogue scale.

Official Title
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A Prospective Randomized Trial Comparing Standard Ligament Reconstruction Tendon Interposition (LRTI) VS Ligament Reconstruction Tendon Interposition (LRTI) With an Interference Screw for Thumb Carpometacarpal Arthritis - Pilot Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: LRTI
* Device: Biotenodesis Screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First CMC primary osteoarthritis refractory to conservative treatment Patient >age 18 Able to read and understand English Available for 2 year follow up Exclusion Criteria: Inflammatory Arthritis Active infection in the first CMC joint Concomitant neuropathy Previous surgical procedure on the thumb Active or status post CRPS Severe ¨Z ¨deformity that requires palmar plate advancement Unwilling to participate in a research project Contralateral first CMC joint surgery

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LRTI without a Biotenodesis Screw<br>Ligament Reconstruction Tendon Interposition without a Biotenodesis Screw | Procedure: LRTI<br> <br> |
| Active Comparator: LRTI with Biotenodesis Screw<br>Ligament Reconstruction Tendon Interposition with Biotenodesis Screw | Procedure: LRTI<br> <br> Device: Biotenodesis Screw<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsidence of CMC joint | Measurement of trapezial height as a percentage of pre-operative height | 6 weeks, 3 months, 6 months, 1 year, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D Health Questionnaire Score |  | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | 
| DASH questionnaire score |  | Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years | 
| Grip strength as measured by dynamometer |  | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Pinch strength as measured by dynamometer |  | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Opposition as measured by goniometer | thumb range of motion | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Radial abduction as measured by goniometer | thumb range of motion | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Palmar abduction as measured by goniometer | thumb range of motion | Baseline, 3 months, 6 months, 1 year, 2 years | 
| Pain score on the visual analogue scale | visual analogue scale | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carpometacarpal joints