Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05412615

PRC 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Wrist Osteoarthritis

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth Steadman Hawkins Clinic Inverness

Englewood, Colorado, 80112, United States

Location status: Recruiting

Location contact

Emma Judge

CONTACT

[email protected]

720-872-4850

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meniscus Allograft Transplantation with Proximal Row Carpectomy

Procedure

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

Proximal Row Carpectomy

Procedure

Standard proximal row carpectomy with no tissue or synthetic adjuncts

Primary outcomes

  1. DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op

    Time frame: Preoperatively

    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.

  2. DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 2 weeks

    Time frame: 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.

  3. DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 weeks

    Time frame: 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.

  4. DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 3 months

    Time frame: 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.

  5. DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 months

    Time frame: 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. DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 9 months

    Time frame: 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.

  7. DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 12 months

    Time frame: 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.

  8. DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 24 months

    Time frame: 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.

Secondary outcomes

  1. Pain Score

    Time frame: Preoperatively, up to 24 Months

    Visual Analog Pain Score

  2. Radiographic joint spacing

    Time frame: 3 months, up to 24 Months

    Measurement of joint spacing in the wrist in millimeters.

  3. MRI Joint Spacing

    Time frame: 9 Months, 24 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Judge

CONTACT

[email protected]

720-872-4850

Fraser J Leversedge, MD

CONTACT

[email protected]

919-316-0616

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2022
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.