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:
Tornier, Inc.
Information provided by (Responsible Party):
Tornier, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 :
- Number of device associated and procedure associated adverse events [ Time Frame: up to 20 years ]
Secondary Outcome Measures :
- Rates of reoperation and revision surgery [ Time Frame: up to 20 years ]
Other Outcome Measures:
- 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
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.
| 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
| 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
| 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:
| 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:
|
Fractures, Bone Wounds and Injuries |