Recruiting

PRC with Meniscal Allograft

Sponsor:

University of Colorado, Denver

Code:

NCT05412615

Conditions

Wrist Osteoarthritis

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Meniscus Allograft Transplantation with Proximal Row Carpectomy

Proximal Row Carpectomy

Study Details

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.

Conditions

Wrist Osteoarthritis

Study ID

NCT05412615

Start date

Sep 1, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Meniscal Allograft with PRC

These patients will receive a tissue allograft with their wrist reconstruction procedure.

placebo comparator: PRC only

These patients will receive the standard proximal row carpectomy procedure.

Interventions

Meniscus Allograft Transplantation with Proximal Row Carpectomy

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

Proximal Row Carpectomy

Standard proximal row carpectomy with no tissue or synthetic adjuncts

Primary outcome measure

  • DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op [ Time Frame: Preoperatively ]
  • DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 2 weeks [ Time Frame: 2 weeks ]
  • DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 weeks [ Time Frame: 6 weeks ]
  • DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 3 months [ Time Frame: 3 months ]
  • DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 months [ Time Frame: 6 months ]
  • DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 9 months [ Time Frame: 9 months ]
  • DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 12 months [ Time Frame: 12 months ]
  • DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 24 months [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Fraser J Leversedge, MD

919-316-0616fraser.leversedge@cuanschutz.edu

Emma Judge

720-872-4850emma.judge@cuanschutz.edu

Locations

UCHealth Steadman Hawkins Clinic Inverness

Recruiting

Englewood, Colorado, United States, 80112

Contacts

Emma Judge

720-872-4850emma.judge@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 10, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-02-10.