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

Tornier Shoulder Outcomes Clinical Study

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.

Study Overview

• Status: Terminated
• Conditions: Shoulder Arthroplasty and Fracture Repair
• Intervention / Treatment: Device: Shoulder Arthroplasty

• Study Type: Observational
• Enrollment (Actual): 7500

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • San Francisco, California, United States, 94115
      • California Pacific Orthopaedics
  • Colorado
    • Denver, Colorado, United States, 80218
      • Western Orthopaedics
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Resurgens Orthopaedics
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Sports Medicine Clinic
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Lexington Clinic Orthopedics - Sports Medicine Center
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Great Lakes Orthopaedic Center
  • Minnesota
    • Edina, Minnesota, United States, 55439
      • Allina Health Orthopedics
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of MO - Columbia
  • New Jersey
    • Jersey City, New Jersey, United States, 07030
      • Jersey Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute Orthopaedics
  • Texas
    • Austin, Texas, United States, 78758
      • Ascension Medical Group Seton Orthopedics
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Houston, Texas, United States, 77030
      • Fondren Orthopedic Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from United States and Europe

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of reoperation and revision surgery	The cumulative incidence of device revisions and reoperations will be reported as well as Kaplan-Meier estimates for implant survival at the end of the clinical investigation.	up to 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline and previous visit in SANE scores	SANE = Single Assessment Numeric Evaluation	at 1, 2, 5, 7, 10, 15, and 20 years follow-up
Time to first revision surgery	Time from primary study surgery to revision surgery	up to 10 years
Change from baseline and previous visit in ASES scores	ASES Score = American Shoulder and Elbow Surgeons Score	at 1, 2, 5, 7, and 10 years of follow-up
Constant Score	The total score by visit and the within subject score changes of the Constant Total Score from visit to visit will be analyzed to help identify the changes on the subject level. This analysis will be part of the final report.	at 1, 2, 5, 7, and 10 years of follow-up
Subject Satisfaction	The total score by visit and the within subject score changes of the Patient Satisfaction Score from visit to visit will be analyzed to help identify the changes on the subject level (assessed as improved, worsened or no change). This analysis will be part of the final report.	at 1, 2, 5, 7, and 10 years of follow-up
Cumulative incidence of migration, radiolucency, osteolysis, and bone wear	as assessed by available X-ray, CT, or MRI	at 1, 2, 5, 7, and 10 years of follow-up
EQ-5D-5L	The total score by visit and the within subject score changes of the EQ-5D-5L from visit to visit will be analyzed to help identify the changes on the subject level (assessed as improved, worsened or no change). This analysis will be part of the final report.	at 1, 2, 5, 7, and 10 years of follow-up

Collaborators and Investigators

• Sponsor: Stryker Trauma and Extremities
• Investigators: Study Director: Rebecca Gibson, Stryker Trauma & Extremities

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): September 12, 2024
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 24, 2014
• First Posted (Estimated): January 29, 2014

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 13B-T-SHOULDER-RM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No