Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients

NCT02047955 | Terminated FDA Device

• 1 other identifier: 13B-T-SHOULDER-RM
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 15

Brief Summary

The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.

Conditions

Shoulder Arthroplasty and Fracture Repair

Outcome Measures

Primary Outcomes (1)

• Number of device associated and procedure associated adverse events

  Adverse events will be evaluated from inclusion to last follow-up and will be documented during the study and categorized as whether they are serious and whether they are related to the Sponsor device or implant procedure.

  up to 10 years

Secondary Outcomes (1)

• Rates of reoperation and revision surgery

  up to 10 years

Other Outcomes (7)

• Time to first revision surgery

  up to 10 years

• Change from baseline and previous visit in ASES scores

  at 1, 2, 5, 7, and 10 years of follow-up

• Constant Score

  at 1, 2, 5, 7, and 10 years of follow-up

Interventions

Shoulder Arthroplasty DEVICE

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

Also known as: Osteosynthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from United States and Europe

You may qualify if:

• years or older
• 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

You may not qualify if:

• Patients who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (15)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

California Pacific Orthopaedics

San Francisco, California, 94115, United States

Location

Western Orthopaedics

Denver, Colorado, 80218, United States

Location

Resurgens Orthopaedics

Atlanta, Georgia, 30342, United States

Location

University of Iowa Sports Medicine Clinic

Iowa City, Iowa, 52242, United States

Location

Lexington Clinic Orthopedics - Sports Medicine Center

Lexington, Kentucky, 40504, United States

Location

Great Lakes Orthopaedic Center

Traverse City, Michigan, 49684, United States

Location

Allina Health Orthopedics

Edina, Minnesota, 55439, United States

Location

University of MO - Columbia

Columbia, Missouri, 65212, United States

Location

Jersey Medical Center

Jersey City, New Jersey, 07030, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Rothman Institute Orthopaedics

Philadelphia, Pennsylvania, 19107, United States

Location

Ascension Medical Group Seton Orthopedics

Austin, Texas, 78758, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Fondren Orthopedic Group

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Shoulder; Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Fracture Fixation; Therapeutics

Study Officials

• Rebecca Gibson

  Stryker Trauma & Extremities

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 29, 2014
• Study Start: March 1, 2014
• Primary Completion: September 12, 2024
• Study Completion: October 16, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)