PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis (PRC)

Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Wrist Osteoarthritis
• Intervention / Treatment: Procedure: Meniscus Allograft Transplantation with Proximal Row Carpectomy; Procedure: Proximal Row Carpectomy

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fraser J Leversedge, MD; Phone Number: 919-316-0616; Email: fraser.leversedge@cuanschutz.edu
• Study Contact Backup: Name: Emma Judge; Phone Number: 720-872-4850; Email: emma.judge@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80112
      • Recruiting
      • UCHealth Steadman Hawkins Clinic Inverness
      • Contact: Emma Judge; Phone Number: 720-872-4850; Email: emma.judge@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• symptomatic wrist arthritis associated with SLAC or SNAC pathology
• Patients 30 years or older or 80 years or younger

Exclusion Criteria:

• Patients younger than 29 years or older than 80 years
• History of previous surgery related to wrist osteoarthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 21-3148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No