PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Study Overview
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Brief Summary
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This study plans to learn more about the effect of adding tissue graft for wrist osteoarthritis reconstruction procedures. Previous studies have shown better allograft stability, and no documented foreign body reaction than with silicone and other synthetic materials.

Official Title
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Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Conditions
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Wrist Osteoarthritis

Intervention / Treatment
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* Procedure: Meniscus Allograft Transplantation with Proximal Row Carpectomy
* Procedure: Proximal Row Carpectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic wrist arthritis associated with SLAC or SNAC pathology Patients 30 years or older Exclusion Criteria: Patients 29 years or younger History of previous surgery related to wrist osteoarthritis

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 88 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meniscal Allograft with PRC<br>These patients will receive a tissue allograft with their wrist reconstruction procedure. | Procedure: Meniscus Allograft Transplantation with Proximal Row Carpectomy<br>* Supplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores.<br>|
| Placebo Comparator: PRC only<br>These patients will receive the standard proximal row carpectomy procedure. | Procedure: Proximal Row Carpectomy<br>* Standard proximal row carpectomy with no tissue or synthetic adjuncts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op | Participant wrist disability score will be assessed before and after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question. | Preoperatively | 
| DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 2 weeks | Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question. | 2 weeks | 
| DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 weeks | Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question. | 6 weeks | 
| DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 3 months | Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question. | 3 months | 
| DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 months | Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question. | 6 months | 
| DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 9 months | Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question. | 9 months | 
| DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 12 months | Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question. | 12 months | 
| DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 24 months | Participant wrist disability score after their wrist reconstruction procedure. Disability of the arm, shoulder and hand (DASH) score ranges from (0-100) with higher score being worse and representing more disability. Lower scores are better and represent less disability. The questionnaire contains 11 questions about daily tasks which are rated 1 (no difficulty) to 5 (Unable to perform) for each question. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Visual Analog Pain Score | Preoperatively, up to 24 Months | 
| Radiographic joint spacing | Measurement of joint spacing in the wrist in millimeters. | 3 months, up to 24 Months | 
| MRI Joint Spacing | Wrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI) | 9 Months, 24 Months |