PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Not Applicable

Not yet recruiting

• Conditions: Wrist Osteoarthritis
• Interventions: Procedure: Meniscus Allograft Transplantation with Proximal Row Carpectomy; Procedure: Proximal Row Carpectomy

• Registration Number: NCT05412615
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-15
• Study Start: 2023-09-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• symptomatic wrist arthritis associated with SLAC or SNAC pathology
• Patients 30 years or older

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Exclusion Criteria

• Patients 29 years or younger
• History of previous surgery related to wrist osteoarthritis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meniscal Allograft with PRC	Meniscus Allograft Transplantation with Proximal Row Carpectomy	These patients will receive a tissue allograft with their wrist reconstruction procedure.
PRC only	Proximal Row Carpectomy	These patients will receive the standard proximal row carpectomy procedure.

Primary Outcome Measures

Name	Time	Method
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op	Preoperatively	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.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 9 months	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.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 3 months	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.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 months	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.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 12 months	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.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 2 weeks	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.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 weeks	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.
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 24 months	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.

Secondary Outcome Measures

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