Total Shoulder Arthroplasty Multi-Center Registry

NCT ID: NCT03511586

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-28

Study Completion Date

2035-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Shoulder Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthrex, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arizona/Banner Health

Phoenix, Arizona, United States

Site Status RECRUITING

Banner Medical Group

Phoenix, Arizona, United States

Site Status RECRUITING

Scottsdale, Arizona, United States

Site Status RECRUITING

Denver, Colorado, United States

Site Status RECRUITING

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status TERMINATED

Andrews Research & Education Foundation

Gulf Breeze, Florida, United States

Site Status RECRUITING

Advent Health Orlando

Orlando, Florida, United States

Site Status RECRUITING

NorthShore University Health System

Evanston, Illinois, United States

Site Status WITHDRAWN

The Trustees of Indiana University

Indianapolis, Indiana, United States

Site Status RECRUITING

The University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Grand Rapids, Michigan, United States

Site Status TERMINATED

Columbia, Missouri, United States

Site Status TERMINATED

The Rothman Institute

New York, New York, United States

Site Status TERMINATED

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status NOT_YET_RECRUITING

Cleveland Shoulder Institute

Beachwood, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Medford, Oregon, United States

Site Status RECRUITING

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

The Hawkins Foundation

Greenville, South Carolina, United States

Site Status RECRUITING

Germantown, Tennessee, United States

Site Status RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Virginia Beach, Virginia, United States

Site Status RECRUITING

Orthopädische Chirurgie München (OCM)

München, , Germany

Site Status RECRUITING

Schulthess Klinik

Zurich, , Switzerland

Site Status RECRUITING

Countries

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United States Germany Switzerland

Central Contacts

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Kelly Ganz, BA, CCRC

Role: CONTACT

1 (800) 933-7001 ext. 71119

Alicia Ruiz, MS, CCRP, CCRA

Role: CONTACT

1 (800) 933-7001 ext. 71970

Facility Contacts

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Saleh Ahmed

Role: primary

1 (602) 839-2000

Demaris Research Coordinator

Role: primary

1(833) 252-5535

Madison Coordinator

Role: primary

(850)916-8590

Russell Huffman, MD

Role: primary

Charalampos (Bobby) Lyssikatos

Role: primary

317-278-2565

Chris Coordinator

Role: primary

1 (734) 930-7400

Kelsey Coordinator

Role: primary

1 (984) 974-5700

Katherine Leonard

Role: primary

888-716-9253

Howell Thomas

Role: primary

1 (888) 666-2904

Elizabeth Leitch

Role: primary

1 (434) 243-7778

Patric Raiss, Prof. Dr.

Role: primary

Philipp Moroder, Prof. Dr.

Role: primary

Other Identifiers

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608

Identifier Type: -

Identifier Source: org_study_id

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