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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02047955
Recruitment Status : Recruiting
First Posted : January 29, 2014
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Tornier, Inc.

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 Procedure: Shoulder Arthroplasty

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Tornier Shoulder Outcomes Clinical Study
Actual Study Start Date : March 2014
Estimated Primary Completion Date : January 2034
Estimated Study Completion Date : January 2034

Intervention Details:
  • Procedure: Shoulder Arthroplasty
    Other Name: Osteosynthesis


Primary Outcome Measures :
  1. Number of device associated and procedure associated adverse events [ Time Frame: up to 20 years ]

Secondary Outcome Measures :
  1. Rates of reoperation and revision surgery [ Time Frame: up to 20 years ]

Other Outcome Measures:
  1. Time to first revision surgery [ Time Frame: up to 20 years ]
  2. Change from baseline and previous visit in ASES scores [ Time Frame: at 1, 2, 5, 7, 10, 15, and 20 years of follow-up ]
    ASES Score = American Shoulder and Elbow Surgeons Score

  3. Change from baseline and previous visit in Adjusted and unadjusted Constant Murley Scores [ Time Frame: at 1, 2, 5, 7, 10, 15, and 20 years follow-up ]
  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. Change from baseline and previous visit in Subject Satisfaction [ Time Frame: at 1, 2, 5, 7, 10, 15, and 20 years follow-up ]
    assessed as improved, worsened or no change

  6. Cumulative incidence of migration, radiolucency, osteolysis, and bone wear [ Time Frame: at 1, 2, 5, 7, 10, 15, and 20 years follow-up ]
    as assessed by available X-ray, CT, or MRI



Information from the National Library of Medicine

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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, European, Canada, and Australia.
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)

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 Recruiting
Birmingham, Alabama, United States, 35294
Contact: Brent Ponce, MD    205-930-8552      
Principal Investigator: Brent Ponce, MD         
United States, California
San Francisco Shoulder, Elbow, and Hand Clinic Recruiting
San Francisco, California, United States, 94115
Contact: James D Kelly, II, MD    415-392-3225      
Principal Investigator: James D Kelly, II, MD         
United States, Colorado
Western Orthopaedics Recruiting
Denver, Colorado, United States, 80218
Contact: Armodios Hatzidakis, MD    303-321-1333      
Principal Investigator: Armodios Hatzidakis, MD         
United States, Georgia
Resurgens Orthopaedics Recruiting
Atlanta, Georgia, United States, 30342
Contact: Drew Miller, MD    404-531-8507      
Principal Investigator: Drew Miller, MD         
United States, Iowa
University of Iowa Sports Medicine Clinic Terminated
Iowa City, Iowa, United States, 52242
United States, Kentucky
Lexington Clinic Orthopedics - Sports Medicine Center Terminated
Lexington, Kentucky, United States, 40504
United States, Michigan
Great Lakes Orthopaedic Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Christopher Chuinard, MD    231-935-0847      
Principal Investigator: Christopher Chuinard, MD         
United States, Minnesota
Sports & Orthopaedic Specialists Recruiting
Edina, Minnesota, United States, 55439
Contact: Michael Freehill, MD    952-914-8599      
Principal Investigator: Michael Freehill, MD         
United States, Missouri
University of MO - Columbia Active, not recruiting
Columbia, Missouri, United States, 65212
United States, North Carolina
Duke University Terminated
Durham, North Carolina, United States, 27708
United States, Pennsylvania
Rothman Institute Orthopaedics Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Joseph Abboud, MD    800-321-9999      
Principal Investigator: Joseph Abboud, MD         
United States, Texas
Orthopaedic Associates of Central Texas Recruiting
Austin, Texas, United States, 78758
Contact: Robert Graham, MD    512-977-0000      
Principal Investigator: Robert Graham, MD         
UT Southwestern Terminated
Dallas, Texas, United States, 75390
Fondren Orthopedic Group Recruiting
Houston, Texas, United States, 77030
Contact: Thomas B Edwards, MD    713-799-2300      
Principal Investigator: Thomas B Edwards, MD         
Sponsors and Collaborators
Tornier, Inc.
Investigators
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Principal Investigator: Armodios Hatzidakis, MD Western Othopaedics
Principal Investigator: Lionel Neyton, MD Hopital Prive Jean Mermoz
Study Director: Fred Ecklund Wright Medical Technology
Additional Information:

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Responsible Party: Tornier, Inc.
ClinicalTrials.gov Identifier: NCT02047955    
Other Study ID Numbers: 13B-T-SHOULDER-RM
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries