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PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05412615
Enrollment
20
Registered
2022-06-09
Start date
2023-09-01
Completion date
2026-12-31
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrist Osteoarthritis

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.

Interventions

PROCEDUREMeniscus Allograft Transplantation with Proximal Row Carpectomy

Supplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores.

Standard proximal row carpectomy with no tissue or synthetic adjuncts

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 24 months24 monthsParticipant 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 months6 monthsParticipant 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: 9 months9 monthsParticipant 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 months12 monthsParticipant 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: Baseline/Pre-opPreoperativelyParticipant 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: 2 weeks2 weeksParticipant 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 weeks6 weeksParticipant 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 months3 monthsParticipant 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

MeasureTime frameDescription
Radiographic joint spacing3 months, up to 24 MonthsMeasurement of joint spacing in the wrist in millimeters.
MRI Joint Spacing9 Months, 24 MonthsWrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI)
Pain ScorePreoperatively, up to 24 MonthsVisual Analog Pain Score

Countries

United States

Contacts

Primary ContactFraser J Leversedge, MD
fraser.leversedge@cuanschutz.edu919-316-0616
Backup ContactEmma Judge
emma.judge@cuanschutz.edu720-872-4850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026