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Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

Primary Purpose

Basal Joint Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteochondral Allograft
Ligament Reconstruction Tendon Interposition
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Joint Arthritis focused on measuring Allograft, Osteochondral Allograft, Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Indicated for operative management of basal joint arthritis

Exclusion Criteria:

  • Pregnant women/fetuses/neonates, prisoners
  • Previously operated on for treatment of basal joint arthritis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Ligament Reconstruction Tendon Interposition (LRTI)

    Osteochondral Allograft

    Arm Description

    Selected randomly, 100 patients will receive this treatment. During the LRTI (standard of care procedure), the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together.

    Selected randomly,100 patients will receive this treatment. In this procedure, the arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface, known as the 'Cartibend©' .

    Outcomes

    Primary Outcome Measures

    Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
    The DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item questionnaire that includes 21 physical function items, 6 symptom items, and 3 social/role function items used to evaluate a patient's ability to perform upper extremity activities. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).

    Secondary Outcome Measures

    Score on the Thumb Disability Exam (TDX)
    The TDX is a questionnaire that measures changes in thumb function and pain, specifically for those with basal joint arthritis.The TDX is scored on a scale of 0 to 100, with a higher score indicating a greater degree of disability in the thumb.
    Visual Analog Scale for pain (VAS)
    The VAS is a validated technique that measures acute and chronic pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    Full Information

    First Posted
    October 25, 2018
    Last Updated
    October 25, 2018
    Sponsor
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03722537
    Brief Title
    Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
    Official Title
    Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Columbia University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.
    Detailed Description
    Basal joint arthritis of the thumb is a common condition associated with considerable morbidity. Many non-operative and operative treatments have been described, but few multicenter prospective evidence based trials exist comparing standard treatments. This continuing search for consensus and improvement of best clinical practice has been reviewed in a thorough meta-analysis of operative treatments for basal joint arthritis. Operative treatments range from osteotomy, partial or complete trapeziectomy with or without reconstruction of the ligaments, tendon interposition to arthrodesis, however the functional outcome varies. Allograft has been previously described in joint replacement / prosthetic implantation surgery in other areas of the body, however not in the thumb. The purpose of this study is to investigate using osteochondral allograft in the surgical intervention phase of treatment for patients with basal joint arthritis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Basal Joint Arthritis
    Keywords
    Allograft, Osteochondral Allograft, Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ligament Reconstruction Tendon Interposition (LRTI)
    Arm Type
    Active Comparator
    Arm Description
    Selected randomly, 100 patients will receive this treatment. During the LRTI (standard of care procedure), the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together.
    Arm Title
    Osteochondral Allograft
    Arm Type
    Experimental
    Arm Description
    Selected randomly,100 patients will receive this treatment. In this procedure, the arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface, known as the 'Cartibend©' .
    Intervention Type
    Procedure
    Intervention Name(s)
    Osteochondral Allograft
    Other Intervention Name(s)
    Cartibend
    Intervention Description
    The arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ligament Reconstruction Tendon Interposition
    Intervention Description
    During the LRTI, the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together.
    Primary Outcome Measure Information:
    Title
    Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
    Description
    The DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item questionnaire that includes 21 physical function items, 6 symptom items, and 3 social/role function items used to evaluate a patient's ability to perform upper extremity activities. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).
    Time Frame
    Up to 1 year post-operatively
    Secondary Outcome Measure Information:
    Title
    Score on the Thumb Disability Exam (TDX)
    Description
    The TDX is a questionnaire that measures changes in thumb function and pain, specifically for those with basal joint arthritis.The TDX is scored on a scale of 0 to 100, with a higher score indicating a greater degree of disability in the thumb.
    Time Frame
    Up to 1 year post-operatively
    Title
    Visual Analog Scale for pain (VAS)
    Description
    The VAS is a validated technique that measures acute and chronic pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
    Time Frame
    Up to 1 year post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Indicated for operative management of basal joint arthritis Exclusion Criteria: Pregnant women/fetuses/neonates, prisoners Previously operated on for treatment of basal joint arthritis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seth Shoap
    Phone
    484-392-3255
    Email
    scs2217@cumc.columbia.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melvin P Rosenwasser, MD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis

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