Rheumatoid ArthritisREVIVENCT05500066
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
An observational study of Rheumatoid Arthritis and Osteoarthritis Shoulder, run by Stryker Trauma and Extremities at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus
- What is being tested?
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jan 2023to 3 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Coastal Orthopedics
Bradenton, Florida, 34212
HCA Healthcare Research Institute
Denver, Colorado, 80222
Baptist Health Lexington
Lexington, Kentucky, 40503
Foundation for Orthopaedic Research & Education
Tampa, Florida, 33637
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis, Correction of Functional Deformity, Traumatic Arthritis
- Being tested
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Keywords
- Total Shoulder Replacement, Osteoarthritis, Joint Diseases, Musculoskeletal Diseases
- Medical subject headings
- Arthritis, Rheumatoid, Humeral Fractures, Osteonecrosis, Rotator Cuff Injuries, Osteoarthritis, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system | Commercially available shoulder system available in both anatomic and reversed configurations. Receives: Device: Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Month
Secondary outcomes (5)
Constant Score
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.
Measured: through study completion, an average of 1 year
SANE
Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal.
Measured: through study completion, an average of 1 year
EQ 5-D
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.
Measured: through study completion, an average of 1 year
Patient Satisfaction
Single subjective question "How satisfied are you with your shoulder?"
Measured: through study completion, an average of 1 year
Radiographic Findings
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.
Measured: Baseline, 1 year, 2 year, 5 year and 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start11 Jan 2023
- Primary completion6 Jan 2028 (estimated)
- Study completion3 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 110 participants (estimated)
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 and Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500066
- Sponsor's protocol ID
- 20F-W-REVIVE-RM
- Acronym
- REVIVE
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2022
- Last updated
- 30 Mar 2026
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
- ClinicalTrials.gov ID
- NCT05500066
- Acronym / sponsor ID
- REVIVE / 20F-W-REVIVE-RM
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis, Correction of Functional Deformity, Traumatic Arthritis
- Keywords
- Total Shoulder Replacement, Osteoarthritis, Joint Diseases, Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 6 Jan 2028 (estimated)
- Study completion
- 3 Jan 2036 (estimated)
- First posted
- 12 Aug 2022 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system | – | Device: Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder systemCommercially available shoulder system available in both anatomic and reversed configurations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder systemTornier 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. | Device | Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system |
Primary outcome
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
5 secondary outcomes
Constant Score
Time frame: through study completion, an average of 1 year
SANE
Time frame: through study completion, an average of 1 year
EQ 5-D
Time frame: through study completion, an average of 1 year
Patient Satisfaction
Time frame: through study completion, an average of 1 year
Radiographic Findings
Time frame: Baseline, 1 year, 2 year, 5 year and 10 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Rebecca Gibson study director
Stryker Trauma and Extremities
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Osteoarthritis Shoulder, run by Stryker Trauma and Extremities at 4 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 5 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
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?
Average Improvement from Baseline to last follow-up visit in ASES Score (time frame: 24 Month). 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 30 Mar 2026.