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Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

Sponsor
Exactech (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05615246
Collaborator
(none)
100
Enrollment
1
Location
156.8
Anticipated Duration (Months)
0.6
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 Humeral Reconstruction Prosthesis in shoulder arthroplasty 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 :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty
    Actual Study Start Date :
    Sep 5, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2030
    Anticipated Study Completion Date :
    Sep 30, 2031

    Outcome Measures

    Primary Outcome Measures

    1. SST-12 [Through study completion, an average of 1 per year]

      Shoulder Simple Test (SST) - 12 questions with yes/no responses that measure shoulder pain and function from a patient's perspective - 12 yes corresponds to 100%

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

      Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities

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

      Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain

    4. 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

    5. UCLA [Through study completion, an average of 1 per year]

      University of California Los Angeles Shoulder Score (UCLA) - 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes

    6. TESS [Through study completion, an average of 1 per year]

      Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome

    7. MSTS [Through study completion, an average of 1 per year]

      Musculoskeletal Tumor Society (MSTS) - 30 points [6 times (range 0-5)], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score

    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 for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)

    • Patient is at least 21 years of age

    • Patient is expected to survive at least 2 years beyond surgery

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

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

    Exclusion Criteria:

    • Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved

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

    • Neuromuscular disorders that do not allow control of the joint

    • SIgnigicant injury to the brachial plexus

    • Non-functional deltoid muscles

    • 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 adversely 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 Western Orthopaedics Research and Education Foundation Denver Colorado United States 80218

    Sponsors and Collaborators

    • Exactech

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Exactech
    ClinicalTrials.gov Identifier:
    NCT05615246
    Other Study ID Numbers:
    • CR18-001
    First Posted:
    Nov 14, 2022
    Last Update Posted:
    Nov 14, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoarthritis

    Study Results

    No Results Posted as of Nov 14, 2022