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PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis (PRC)

Primary Purpose

Wrist Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Meniscus Allograft Transplantation with Proximal Row Carpectomy
Proximal Row Carpectomy
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Osteoarthritis

Eligibility Criteria

30 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Meniscal Allograft with PRC

    PRC only

    Arm Description

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

    These patients will receive the standard proximal row carpectomy procedure.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Pain Score
    Visual Analog Pain Score
    Radiographic joint spacing
    Measurement of joint spacing in the wrist in millimeters.
    MRI Joint Spacing
    Wrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI)

    Full Information

    First Posted
    June 6, 2022
    Last Updated
    August 14, 2023
    Sponsor
    University of Colorado, Denver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05412615
    Brief Title
    PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis
    Acronym
    PRC
    Official Title
    Proximal Row Carpectomy With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wrist Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Meniscal Allograft with PRC
    Arm Type
    Experimental
    Arm Description
    These patients will receive a tissue allograft with their wrist reconstruction procedure.
    Arm Title
    PRC only
    Arm Type
    Placebo Comparator
    Arm Description
    These patients will receive the standard proximal row carpectomy procedure.
    Intervention Type
    Procedure
    Intervention Name(s)
    Meniscus Allograft Transplantation with Proximal Row Carpectomy
    Intervention Description
    Supplementing the wrist reconstruction with a meniscal allograft to improve wrist function and pain scores.
    Intervention Type
    Procedure
    Intervention Name(s)
    Proximal Row Carpectomy
    Intervention Description
    Standard proximal row carpectomy with no tissue or synthetic adjuncts
    Primary Outcome Measure Information:
    Title
    DISABILITIES OF THE ARM, SHOULDER AND HAND Score: Baseline/Pre-op
    Description
    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
    Title
    DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 2 weeks
    Description
    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
    Title
    DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 weeks
    Description
    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
    Title
    DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 3 months
    Description
    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
    Title
    DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 6 months
    Description
    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
    Title
    DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 9 months
    Description
    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
    Title
    DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 12 months
    Description
    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
    Title
    DISABILITIES OF THE ARM, SHOULDER AND HAND Score: 24 months
    Description
    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 Outcome Measure Information:
    Title
    Pain Score
    Description
    Visual Analog Pain Score
    Time Frame
    Preoperatively, up to 24 Months
    Title
    Radiographic joint spacing
    Description
    Measurement of joint spacing in the wrist in millimeters.
    Time Frame
    3 months, up to 24 Months
    Title
    MRI Joint Spacing
    Description
    Wrist joint spacing measurements in millimeters using Magnetic resonance imaging (MRI)
    Time Frame
    9 Months, 24 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    88 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: symptomatic wrist arthritis associated with SLAC or SNAC pathology Patients 30 years or older Exclusion Criteria: Patients 29 years or younger History of previous surgery related to wrist osteoarthritis

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    PRC With Meniscal Allograft Arthroplasty for Wrist Osteoarthritis

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