Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02047955 |
Recruitment Status :
Active, not recruiting
First Posted : January 29, 2014
Last Update Posted : February 8, 2022
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Condition or disease | Intervention/treatment |
---|---|
Shoulder Arthroplasty and Fracture Repair | Procedure: Shoulder Arthroplasty |
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 |
- Procedure: Shoulder Arthroplasty
Other Name: Osteosynthesis
- Number of device associated and procedure associated adverse events [ Time Frame: up to 20 years ]
- Rates of reoperation and revision surgery [ Time Frame: up to 20 years ]
- Time to first revision surgery [ Time Frame: up to 20 years ]
- 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
- 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 ]
- 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
- 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
- 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

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.
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 |
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)

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
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
San Francisco Shoulder, Elbow, and Hand Clinic | |
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 | |
Sports & Orthopaedic Specialists | |
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 | |
Orthopaedic Associates of Central Texas | |
Austin, Texas, United States, 78758 | |
UT Southwestern | |
Dallas, Texas, United States, 75390 | |
Fondren Orthopedic Group | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Armodios Hatzidakis, MD | Western Othopaedics | |
Principal Investigator: | Lionel Neyton, MD | Hopital Prive Jean Mermoz |
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: | February 8, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Fractures, Bone Wounds and Injuries |