ClinicalTrials.gg
RecruitingNCT05412615Updated Feb 10, 2025

PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

An interventional study of Meniscus Allograft Transplantation with Proximal Row Carpectomy and Proximal Row Carpectomy in Wrist Osteoarthritis, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Wrist Osteoarthritis
03

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.

Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 29 years or older than 80 years
  • History of previous surgery related to wrist osteoarthritis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    PRC only

    These patients will receive the standard proximal row carpectomy procedure.

    Procedure: Proximal Row Carpectomy

Interventions

  • ProcedureMeniscus Allograft Transplantation with Proximal Row Carpectomy

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

  • ProcedureProximal Row Carpectomy

    Standard proximal row carpectomy with no tissue or synthetic adjuncts

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Preoperatively

  2. 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.

    Time frame: 2 weeks

  3. 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.

    Time frame: 6 weeks

  4. 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.

    Time frame: 3 months

  5. 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.

    Time frame: 6 months

  6. 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.

    Time frame: 9 months

  7. 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.

    Time frame: 12 months

  8. 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.

    Time frame: 24 months

Secondary outcomes

  1. Pain Score

    Visual Analog Pain Score

    Time frame: Preoperatively, up to 24 Months

  2. Radiographic joint spacing

    Measurement of joint spacing in the wrist in millimeters.

    Time frame: 3 months, up to 24 Months

  3. MRI Joint Spacing

    Wrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI)

    Time frame: 9 Months, 24 Months

07

Study locations

1 of 1 sites recruiting
  • UCHealth Steadman Hawkins Clinic Inverness
    Englewood, Colorado 80112, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Dec 2026, 39 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2022
First posted
Jun 9, 2022
StartActual
Sep 1, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Feb 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05412615
Responsible party
Sponsor
First posted
Jun 9, 2022
Start date
Sep 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 10, 2025

Study contacts

Fraser J Leversedge, MD
Contact
fraser.leversedge@cuanschutz.edu
919-316-0616
Emma Judge
Contact
emma.judge@cuanschutz.edu
720-872-4850

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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