Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients
NCT ID: NCT02047955
Last Updated: 2025-05-14
Study Results
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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TERMINATED
7500 participants
OBSERVATIONAL
2014-03-31
2024-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Shoulder Arthroplasty
Data will be collected for commercially available Sponsor devices. These systems treat both the humeral and glenoid side of the shoulder joint. The following products will be included in the study in the geographies where they are commercially available.
* Aequalis Ascend Flex Convertible Shoulder System
* Pyrocarbon Humeral Head (used with Aequalis Ascend Flex)
* Simpliciti Shoulder Prosthesis
* Aequalis Reversed Fracture Prosthesis
* Aequalis PerFORM Glenoid
* Aequalis PerFORM+ Glenoid
* Aequalis PerFORM Reversed Glenoid
Devices previously included, but discontinued under clinical investigation plan (CIP) version 4.0:
* Aequalis Resurfacing Head
* Aequalis Ascend Anatomic Shoulder System
* Aequalis IM Humeral Nail - Short and Long
* ORTHOLOC™ SPS (Shoulder Plating System)
* Aequalis Reversed II Shoulder System
* Aequalis Adjustable Reversed Prosthesis
* Aequalis Flex Revive Shoulder System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to comply with the requirements of the study protocol
* Considered for treatment with one or more Tornier shoulder arthroplasty or fracture devices included in this study
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Stryker Trauma and Extremities
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Gibson
Role: STUDY_DIRECTOR
Stryker Trauma & Extremities
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
California Pacific Orthopaedics
San Francisco, California, United States
Western Orthopaedics
Denver, Colorado, United States
Resurgens Orthopaedics
Atlanta, Georgia, United States
University of Iowa Sports Medicine Clinic
Iowa City, Iowa, United States
Lexington Clinic Orthopedics - Sports Medicine Center
Lexington, Kentucky, United States
Great Lakes Orthopaedic Center
Traverse City, Michigan, United States
Allina Health Orthopedics
Edina, Minnesota, United States
University of MO - Columbia
Columbia, Missouri, United States
Jersey Medical Center
Jersey City, New Jersey, United States
Duke University
Durham, North Carolina, United States
Rothman Institute Orthopaedics
Philadelphia, Pennsylvania, United States
Ascension Medical Group Seton Orthopedics
Austin, Texas, United States
UT Southwestern
Dallas, Texas, United States
Fondren Orthopedic Group
Houston, Texas, United States
Countries
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Other Identifiers
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13B-T-SHOULDER-RM
Identifier Type: -
Identifier Source: org_study_id
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