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

May 9, 2025 updated by: Stryker Trauma and Extremities

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of device associated and procedure associated adverse events
Time Frame: up to 10 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rates of reoperation and revision surgery
Time Frame: up to 10 years
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline and previous visit in SANE scores
Time Frame: at 1, 2, 5, 7, 10, 15, and 20 years follow-up
SANE = Single Assessment Numeric Evaluation
at 1, 2, 5, 7, 10, 15, and 20 years follow-up
Time to first revision surgery
Time Frame: up to 10 years
Time from primary study surgery to revision surgery
up to 10 years
Change from baseline and previous visit in ASES scores
Time Frame: at 1, 2, 5, 7, and 10 years of follow-up
ASES Score = American Shoulder and Elbow Surgeons Score
at 1, 2, 5, 7, and 10 years of follow-up
Constant Score
Time Frame: at 1, 2, 5, 7, and 10 years of follow-up
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
Time Frame: at 1, 2, 5, 7, and 10 years of follow-up
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
Time Frame: at 1, 2, 5, 7, and 10 years of follow-up
as assessed by available X-ray, CT, or MRI
at 1, 2, 5, 7, and 10 years of follow-up
EQ-5D-5L
Time Frame: at 1, 2, 5, 7, and 10 years of follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stryker Trauma and Extremities

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rebecca Gibson, Stryker Trauma & Extremities

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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