Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
REVIVE
1 other identifier
observational
110
1 country
4
Brief Summary
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system in both the anatomic and reversed configurations. Retrospective inclusions are allowed: study patients may be enrolled up to 3 months after date of surgery provided that the necessary pre-operative (baseline) and surgery data are accessible. Follow-up visits conducted from 3-month post-surgery onward must be prospective. The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2023
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedStudy Start
First participant enrolled
January 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 3, 2036
March 30, 2026
March 1, 2026
5 years
August 4, 2022
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Improvement from Baseline to last follow-up visit in ASES Score
ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
24 Month
Secondary Outcomes (5)
Constant Score
through study completion, an average of 1 year
SANE
through study completion, an average of 1 year
EQ 5-D
through study completion, an average of 1 year
Patient Satisfaction
through study completion, an average of 1 year
Radiographic Findings
Baseline, 1 year, 2 year, 5 year and 10 year
Study Arms (1)
Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
Commercially available shoulder system available in both anatomic and reversed configurations.
Interventions
Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system is intended for use as: * A replacement of shoulder joints in primary anatomic or in primary reverse * A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. The system also allows for conversion from anatomic to reverse shoulder prosthesis in case of revision.
Eligibility Criteria
Approximately 110 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an anatomic or reversed total shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria.
You may qualify if:
- years or older at the time of the informed consent.
- Informed and willing to sign an informed consent form approved by IRB or Ethics Committee (EC) (when applicable).
- Willing and able to comply with the requirements of the study protocol.
- Considered for a candidate for shoulder arthroplasty using the study device
- Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
You may not qualify if:
- Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
- Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
- Active local or systemic infection, sepsis, or osteomyelitis
- Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery)
- Significant injury to the brachial plexus
- Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
- Neuromuscular disease (e.g., joint neuropathy)
- Patient with known allergy to one of the product materials
- Metabolic disorders which may impair bone formation
- Patient pregnancy
- Planned for two-stage surgery (reassessed at time of surgery)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
HCA Healthcare Research Institute
Denver, Colorado, 80222, United States
Coastal Orthopedics
Bradenton, Florida, 34212, United States
Foundation for Orthopaedic Research & Education
Tampa, Florida, 33637, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rebecca Gibson
Stryker Trauma and Extremities
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2022
First Posted
August 12, 2022
Study Start
January 11, 2023
Primary Completion (Estimated)
January 6, 2028
Study Completion (Estimated)
January 3, 2036
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share