Tornier HRS (Humeral Reconstruction System) Study (REVIVE) (REVIVE)

March 24, 2026 updated by: Stryker Trauma and Extremities

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 primary outcome measure will be measured by the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months.

Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics.

Device revision and adverse events (AEs) will be assessed annually throughout the study. Range of motion and radiographic imaging assessments will also be performed at Years 1, 2, 5 and 10 post-operation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80222
        • HCA Healthcare Research Institute
    • Florida
      • Bradenton, Florida, United States, 34212
        • Coastal Orthopedics
      • Tampa, Florida, United States, 33637
        • Foundation for Orthopaedic Research & Education
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
Commercially available shoulder system available in both anatomic and reversed configurations.
Device: Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Improvement from Baseline to last follow-up visit in ASES Score
Time Frame: 24 Month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Constant Score
Time Frame: through study completion, an average of 1 year
A score based on a 100-point scale determined by objective measurements made by the physician in the clinic and subjective values based on pain and activities of daily living reported by the patient.
through study completion, an average of 1 year
SANE
Time Frame: through study completion, an average of 1 year
Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal.
through study completion, an average of 1 year
EQ 5-D
Time Frame: through study completion, an average of 1 year
Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status.
through study completion, an average of 1 year
Patient Satisfaction
Time Frame: through study completion, an average of 1 year
Single subjective question "How satisfied are you with your shoulder?"
through study completion, an average of 1 year
Radiographic Findings
Time Frame: Baseline, 1 year, 2 year, 5 year and 10 year
Images will be reviewed by a single orthopedic surgeon to assess for standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics.
Baseline, 1 year, 2 year, 5 year and 10 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stryker Trauma and Extremities

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rebecca Gibson, Stryker Trauma and Extremities

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20F-W-REVIVE-RM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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