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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meniscal Allograft with PRC | Experimental | These patients will receive a tissue allograft with their wrist reconstruction procedure. |
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| PRC only | Placebo Comparator | These patients will receive the standard proximal row carpectomy procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meniscus Allograft Transplantation with Proximal Row Carpectomy | Procedure | Supplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fraser J Leversedge, MD | Contact | 919-316-0616 | fraser.leversedge@cuanschutz.edu | |
| Emma Judge | Contact | 720-872-4850 | emma.judge@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth Steadman Hawkins Clinic Inverness | Recruiting | Englewood | Colorado | 80112 | United States |
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| Proximal Row Carpectomy | Procedure | Standard proximal row carpectomy with no tissue or synthetic adjuncts |
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| 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 |
| 3 months, up to 24 Months |
| MRI Joint Spacing | Wrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI) | 9 Months, 24 Months |