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

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ClinicalTrials.gov Identifier: NCT02047955
Recruitment Status : Active, not recruiting
First Posted : January 29, 2014
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Stryker Trauma GmbH

Study Description
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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.

Condition or disease Intervention/treatment
Shoulder Arthroplasty and Fracture Repair Device: Shoulder Arthroplasty

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 7500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Tornier Shoulder Outcomes Clinical Study
Actual Study Start Date : March 2014
Estimated Primary Completion Date : January 2032
Estimated Study Completion Date : January 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Groups and Cohorts
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Intervention Details:
  • Device: 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 Name: Osteosynthesis

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Time to first revision surgery [ Time Frame: up to 10 years ]
    Time from primary study surgery to revision surgery

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from United States and Europe
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047955


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

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Responsible Party: Stryker Trauma GmbH
ClinicalTrials.gov Identifier: NCT02047955    
Other Study ID Numbers: 13B-T-SHOULDER-RM
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries