Shoulder ArthroplastyNCT03880955
A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
An observational study of Shoulder Arthroplasty, run by Stryker Trauma and Extremities at 3 sites in United States.
Trial summary
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Shoulder Arthroplasty
- What is being tested?
- ReUnion RSA System
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jun 2019to 13 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Adult, Older adult
Study population: 80 subjects are to be enrolled in this clinical investigation. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.
Who may be able to join
- Subject is willing to sign the informed consent.
- Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
- Subject is male or non-pregnant female and 18 years or older at the time of surgery.
- Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following:
- Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis
- Failed previous shoulder joint replacement
Who cannot join
- Subject has an active or suspected latent infection in or about the shoulder joint.
- Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
- Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
- Subject has concomitant disease(s) which may significantly affect the clinical outcome.
- Subject has traumatic or pathologic fracture of the proximal humerus
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37209
Great Plains Orthopedics
Peoria, Illinois, 61605
About this study
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.
Read the detailed description
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RSA System will be demonstrated through reporting of device-related intra-operative and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.
- Conditions
- Shoulder Arthroplasty
- Being tested
- ReUnion RSA System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReUnion RSA SystemDevice
The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components.
| Study group | Role | What they receive |
|---|---|---|
| ReUnion RSA System | Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following:
* Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis
* Failed previous shoulder joint replacement Receives: Device: ReUnion RSA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Measured: 24 Months
Secondary outcomes (3)
Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events.
Secondary outcome measures to assess safety by capturing the incidence rate of device-related intra-operative adverse events.
Measured: 24 months
Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events.
Secondary outcome measures to assess safety by capturing the incidence rate of device-related post-operative adverse events.
Measured: 24 months
Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System.
Secondary outcome measures to assess efficacy by monitoring all implant survivorship in all subjects who have the reverse total shoulder endoprosthesis with the ReUnion RSA System.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start25 Jun 2019
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Why it stopped: Sponsor decision to stop at 2 year follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder ArthroplastyStudies 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
- 102 participants (actual)
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
- NCT03880955
- Sponsor's protocol ID
- ReUnion RSA Study
- Status last verified
- Jan 2025
- First submitted
- 7 Mar 2019
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
- ClinicalTrials.gov ID
- NCT03880955
- Acronym / sponsor ID
- ReUnion RSA Study
- Conditions
- Shoulder Arthroplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision to stop at 2 year follow-up
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.
Detailed description
The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion RSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion RSA System will be demonstrated through reporting of device-related intra-operative and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReUnion RSA System | – | Device: ReUnion RSA SystemSubject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following: * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis * Failed previous shoulder joint replacement |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 80 subjects are to be enrolled in this clinical investigation. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.
Key inclusion criteria (6 listed)
- Subject is willing to sign the informed consent.
- Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
- Subject is male or non-pregnant female and 18 years or older at the time of surgery.
- Subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant and subject has one or more of the following:
Key exclusion criteria (7 listed)
- Subject has an active or suspected latent infection in or about the shoulder joint.
- Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
- Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
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 |
|---|---|---|
| ReUnion RSA SystemThe ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components. | Device | ReUnion RSA System |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Time frame: 24 Months
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
3 secondary outcomes
Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative Adverse Events.
Time frame: 24 months
Safety Will be Measured by Capturing the Incidence Rate of Device-related Post-operative Adverse Events.
Time frame: 24 months
Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Reverse Total Shoulder Endoprosthesis With the ReUnion RSA System.
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Shoulder Arthroplasty
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Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
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INHANCE Stemless Reverse Shoulder IDE
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RecruitingPhase 4
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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. This study is not recruiting at the moment.
Rebecca Gibson study director
Stryker Trauma and Extremities
3 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, run by Stryker Trauma and Extremities at 3 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 6 inclusion and 7 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 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
American Shoulder and Elbow Surgeons (ASES) Shoulder Score (time frame: 24 Months). 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 9 Jan 2025.