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Total Shoulder Arthroplasty Multi-Center Registry

Sponsor
Arthrex, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03511586
Collaborator
(none)
2,500
Enrollment
17
Locations
147.4
Anticipated Duration (Months)
147.1
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study is a non-randomized multi-center prospective registry and subjects will be treated according to standard of care at each center. Subjects will be approached for participation in this study after they have made the decision to undergo a primary or revision shoulder arthroplasty procedure. The treating surgeon will obtain verbal consent from the patient for a research coordinator to screen for eligibility. Patients who meet all criteria will be offered enrollment into the study. The total enrollment goal is a minimum of 500 anatomic shoulder arthroplasty and 500 reverse shoulder arthroplasty subjects enrolled in the multi-center registry.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Total Shoulder Arthroplasty Multi-Center Registry
    Actual Study Start Date :
    Jul 28, 2015
    Anticipated Primary Completion Date :
    Jul 28, 2025
    Anticipated Study Completion Date :
    Nov 10, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Change in Pain [10 years]

      Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.

    2. Patient is between the ages of 18 and 100 years.

    3. The patient has a planned primary or revision implantation of an anatomic (hemi-arthroplasty or total arthroplasty) or a reverse shoulder prosthesis system manufactured by Arthrex.

    4. Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning.

    Exclusion Criteria

    1. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona/Banner Health Phoenix Arizona United States 85006
    2 Banner Medical Group Phoenix Arizona United States 85016
    3 Scottsdale Arizona United States
    4 Denver Colorado United States
    5 University of Connecticut Health Center Farmington Connecticut United States 06030
    6 The University of Michigan Ann Arbor Michigan United States 48105
    7 Grand Rapids Michigan United States
    8 Columbia Missouri United States
    9 The Rothman Institute New York New York United States 10022
    10 University of North Carolina Chapel Hill North Carolina United States 27599
    11 Cleveland Shoulder Institute Beachwood Ohio United States 44122
    12 Medford Oregon United States
    13 The Hawkins Foundation Greenville South Carolina United States 29615
    14 Germantown Tennessee United States
    15 University of Virginia Charlottesville Virginia United States 22903
    16 Virginia Beach Virginia United States
    17 Orthopädische Chirurgie München (OCM) München Germany 81369

    Sponsors and Collaborators

    • Arthrex, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arthrex, Inc.
    ClinicalTrials.gov Identifier:
    NCT03511586
    Other Study ID Numbers:
    • 608
    First Posted:
    Apr 30, 2018
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Aug 12, 2022