Shoulder Arthroplasty and Fracture RepairNCT02047955
Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients
An observational study of Shoulder Arthroplasty and Fracture Repair, run by Stryker Trauma and Extremities at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroplasty and Fracture Repair
- What is being tested?
- Shoulder Arthroplasty
- Type of treatment
- Medical device
- How many people
- 7,500 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2014to 16 Oct 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from United States and Europe
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Resurgens Orthopaedics
Atlanta, Georgia, 30342
Ascension Medical Group Seton Orthopedics
Austin, Texas, 78758
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of MO - Columbia
Columbia, Missouri, 65212
UT Southwestern
Dallas, Texas, 75390
Western Orthopaedics
Denver, Colorado, 80218
Duke University
Durham, North Carolina, 27708
Allina Health Orthopedics
Edina, Minnesota, 55439
Fondren Orthopedic Group
Houston, Texas, 77030
University of Iowa Sports Medicine Clinic
Iowa City, Iowa, 52242
Jersey Medical Center
Jersey City, New Jersey, 07030
Lexington Clinic Orthopedics - Sports Medicine Center
Lexington, Kentucky, 40504
Rothman Institute Orthopaedics
Philadelphia, Pennsylvania, 19107
California Pacific Orthopaedics
San Francisco, California, 94115
Great Lakes Orthopaedic Center
Traverse City, Michigan, 49684
About this study
Official title: 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.
- Being tested
- Shoulder Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder ArthroplastyDevice
Also called Osteosynthesis
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of device associated and procedure associated adverse events
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.
Measured: up to 10 years
Secondary outcomes (1)
Rates of reoperation and revision surgery
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.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startMar 2014
- Primary completion12 Sep 2024
- Study completion16 Oct 2024
Why it stopped: Sponsor business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Arthroplasty and Fracture RepairStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Gibson, Study director, Stryker Trauma & Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047955
- Sponsor's protocol ID
- 13B-T-SHOULDER-RM
- Status last verified
- May 2025
- First submitted
- 24 Jan 2014
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tornier Shoulder Outcomes Clinical Study
- ClinicalTrials.gov ID
- NCT02047955
- Acronym / sponsor ID
- 13B-T-SHOULDER-RM
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor business decision
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from United States and Europe
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder ArthroplastyAlso: OsteosynthesisData 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 | Device | – |
Primary outcome
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.
1 secondary outcome
Rates of reoperation and revision surgery
Time frame: up to 10 years
Results and safety
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma & Extremities
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroplasty and Fracture Repair, run by Stryker Trauma and Extremities at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of device associated and procedure associated adverse events (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.