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Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up

Sponsor
Exactech (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05703958
Collaborator
(none)
151
Enrollment
1
Location
139.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    151 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2033
    Anticipated Study Completion Date :
    Sep 30, 2034

    Outcome Measures

    Primary Outcome Measures

    1. Smart Score [Through study completion, an average of 1 per year]

      Shoulder Arthroplasty Smart (SAS) score - 6 questions based on 3 objective active range of motion and 3 subjective measures of pain and function. Score range of 0 to 100 where 100 indicates the best score

    2. Sane Score [Through study completion, an average of 1 per year]

      Single Assessment Numeric Evaluation (SANE) - Patient shoulder self-evaluation as a percentage of normal, 100% corresponds being normal

    3. ASES [Through study completion, an average of 1 per year]

      American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition

    4. Quick DASH [Through study completion, an average of 1 per year]

      Shorten version of Disability of the Arm, Shoulder, and Hand (DASH) - 11 items to measure ability of a patient to perform certain upper extremity where 0 corresponds to no difficulty and 100 corresponds to unable

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate

    • Patient is willing to participate by complying with pre- and postoperative visit requirements

    • Patient is willing to agree to be followed for up to 10 years following their index surgery

    • Patient is willing and able to review and sign a study informed consent form

    Exclusion Criteria:

    • Osteomyelitis of the proximal humerus or scapula

    • Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis

    • Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system

    • The patient is unwilling or unable to comply with the post-operative care instructions

    • Alcohol, drug, or other subtance abuse

    • Any disease state that could adversaly affect the function or longevity of the implant

    • Patient is pregnant

    • Patient is a prisoner

    • Patient has a physical or mental condition that would invalidate the results

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Grossman School of Medicine New York New York United States 10016

    Sponsors and Collaborators

    • Exactech

    Investigators

    • Principal Investigator: Abhishek Ganta, MD, NYU Grossman School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Exactech
    ClinicalTrials.gov Identifier:
    NCT05703958
    Other Study ID Numbers:
    • CR21-001
    First Posted:
    Jan 30, 2023
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fracture Dislocation
    Fractures, Bone
    Humeral Fractures
    Shoulder Fractures
    Fractures, Ununited

    Study Results

    No Results Posted as of Jan 30, 2023