Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

Study Overview
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Brief Summary
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This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.

Detailed Description
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Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described, but few multicenter prospective evidence based trials exist comparing standard treatments. This continuing search for consensus and improvement of best clinical practice has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Operative treatments range from osteotomy, partial or complete trapeziectomy with or without reconstruction of the ligaments, tendon interposition to arthrodesis, however the functional outcome varies. Allograft has been previously described in joint replacement / prosthetic implantation surgery in other areas of the body, however not in the thumb. The purpose of this study is to investigate using osteochondral allograft in the surgical intervention phase of treatment for patients with basal joint arthritis.

Official Title
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Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

Conditions
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Basal Joint Arthritis

Intervention / Treatment
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* Procedure: Osteochondral Allograft
* Procedure: Ligament Reconstruction Tendon Interposition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Indicated for operative management of basal joint arthritis Exclusion Criteria: Pregnant women/fetuses/neonates, prisoners Previously operated on for treatment of basal joint arthritis

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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Accepts Healthy Volunteers

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: Ligament Reconstruction Tendon Interposition (LRTI)<br>Selected randomly, 100 patients will receive this treatment. During the LRTI (standard of care procedure), the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together. | Procedure: Ligament Reconstruction Tendon Interposition<br>* During the LRTI, the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together.<br>|
| Experimental: Osteochondral Allograft<br>Selected randomly,100 patients will receive this treatment. In this procedure, the arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface, known as the 'Cartibend©' . | Procedure: Osteochondral Allograft<br>* The arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface.<br>* Other names: Cartibend;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | The DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item questionnaire that includes 21 physical function items, 6 symptom items, and 3 social/role function items used to evaluate a patient's ability to perform upper extremity activities. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability). | Up to 1 year post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Thumb Disability Exam (TDX) | The TDX is a questionnaire that measures changes in thumb function and pain, specifically for those with basal joint arthritis.The TDX is scored on a scale of 0 to 100, with a higher score indicating a greater degree of disability in the thumb. | Up to 1 year post-operatively | 
| Visual Analog Scale for pain (VAS) | The VAS is a validated technique that measures acute and chronic pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | Up to 1 year post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allograft, Osteochondral Allograft, Arthritis