NCT05412615

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Sep 2023Dec 2026

First Submitted

Initial submission to the registry

June 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

3.3 years

First QC Date

June 6, 2022

Last Update Submit

February 6, 2025

Conditions

Wrist Osteoarthritis

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (3)

  • Pain Score

    Preoperatively, up to 24 Months

  • Radiographic joint spacing

    3 months, up to 24 Months

  • MRI Joint Spacing

    9 Months, 24 Months

Study Arms (2)

Meniscal Allograft with PRC

EXPERIMENTAL

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

Procedure: Meniscus Allograft Transplantation with Proximal Row Carpectomy

PRC only

PLACEBO COMPARATOR

These patients will receive the standard proximal row carpectomy procedure.

Procedure: Proximal Row Carpectomy

Interventions

Meniscus Allograft Transplantation with Proximal Row CarpectomyPROCEDURE

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

Meniscal Allograft with PRC
Proximal Row CarpectomyPROCEDURE

Standard proximal row carpectomy with no tissue or synthetic adjuncts

PRC only

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCHealth Steadman Hawkins Clinic Inverness

Englewood, Colorado, 80112, United States

RECRUITING

Central Study Contacts

Fraser J Leversedge, MD

CONTACT

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

Emma Judge

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 9, 2022

Study Start

September 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)