Rotator Cuff InjuriesNCT05215600
Anaverse™ Glenoid System and Its Instrumentation
An observational study of Rotator Cuff Injuries and Shoulder Pain, run by Zimmer Biomet at 1 site in Switzerland.
Trial summary
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy
- What is being tested?
- Anaverse Shoulder System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 May 2022to 23 Apr 2024
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Patients suffering from severe shoulder pain and disability indicated for implantation of the Anaverse™ Glenoid System in cases of total shoulder arthroplasty in reversed configuration. Patients who underwent total shoulder arthroplasty conversion from anatomical to reversed will be enrolled for subgroup analysis. Patients must meet all inclusion and none of the exclusion criteria.
Who may be able to join
- Patient is 18-75 years of age, inclusive.
- Patient is skeletally mature.
- Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
- Patient must have signed EC-approved informed consent.
- Patient requires a primary reversed total shoulder arthroplasty or a conversion from anatomical to reversed to relieve pain and restore the joint function.
- Patient has adequate quality and quantity of bone stock to support the prosthesis.
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- Patient meets at least one of the following indications:
- Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis
- Conditions consequent to earlier operations
- Omarthrosis or Osteoarthritis
- Rheumatoid arthritis
- Total joint reconstruction following trauma
- Patient has significant shoulder disability due to gross and irreparable rotator cuff deficiency. A functional deltoid muscle is necessary to use the device.
- Patient underwent reverse total shoulder reconstruction with the Anaverse Glenoid System before the date of site initiation.
- Patient has demographic, pre-operative evaluation, operative report and device information available.
- Specific inclusion criteria for Conversion from Anatomical to Reversed Configuration:
- Surgery was performed with the Anaverse Glenoid System in a previously available anatomical configuration.
- Irreparable rotator cuff with superior migration of the humeral head, leading to a reduction in sub-acromial space.
- Superior tilt of the Anaverse Glenoid Baseplate not exceeding 15° compared to scapular axis.
- No evidence of mechanical or fixation failure of the Baseplate, TM Pegs or DPSC Screws, obtained pre- or intra-operatively, which would compromise the success of the conversion surgery.
Who cannot join
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient has any condition which would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- Patient has any physical conditions that would impair adequate implant support and/or prevent the use of an appropriately sized implant.
- Patient has any sign of infection (affecting the shoulder joint or in its proximity).
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- Patient has glenoid presenting with large defects due to erosion, which would lead to insufficient bony support or malalignment of the devices.
- Patient is skeletally immature.
- Patient has any sign of neuromuscular compromise (excluding rotator cuff tear).
- Patient has vascular deficiency in the affected limb in sufficient degree to endanger the success of the intervention.
- Patient has absence of musculo-ligamentous supporting structures.
- Patient suffers from joint neuropathy or other conditions that may lead to inadequate skeletal fixation.
- Patient has significant injury to the upper brachial plexus.
- Patient has non-functional deltoid muscle.
- Specific exclusion criteria for Conversion from Anatomical to Reversed Configuration:
- Unstable fixation of Baseplate after removal of PE Liner.
- Superior tilt of Baseplate exceeding 15° compared to scapular axis
- Superior malposition of the Baseplate which would prevent correct assembly of the Glenosphere.
- Evidence of mechanical or fixation failure of the Baseplate, TM Pegs or DPSC Screws, obtained pre- or intra-operatively, which would compromise the success of the conversion surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anaverse™ Glenoid System and Its Instrumentation - Retrospective and Prospective, Non-Controlled Post Market Clinical Follow-Up Study
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
Read the detailed description
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, survival, and radiographic parameters of all enrolled study subjects.
The primary endpoint is defined by the survival of the implant system at 2 years which is based on removal or intended removal of the Anaverse™ Glenoid System baseplate and will be determined by using the Kaplan Meier method.
- Being tested
- Anaverse Shoulder System
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaverse Shoulder SystemDevice
Reverse Shoulder Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Anaverse Shoulder System subjects | Subjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. Receives: Device: Anaverse Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of Implant System (Kaplan Meier)
The primary endpoint of this study is the survival of the implant (Reversed configuration) after 2 years, which is based on removal of the baseplate and will be determined using the Kaplan-Meier method.
Measured: 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start6 May 2022
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Why it stopped: Termination of PMCF study due to product discontinuation.
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 Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215600
- Sponsor's protocol ID
- CME2017-11E
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2022
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaverse™ Glenoid System and Its Instrumentation - Retrospective and Prospective, Non-Controlled Post Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT05215600
- Acronym / sponsor ID
- CME2017-11E
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Termination of PMCF study due to product discontinuation.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 6 May 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
Detailed description
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, survival, and radiographic parameters of all enrolled study subjects.
The primary endpoint is defined by the survival of the implant system at 2 years which is based on removal or intended removal of the Anaverse™ Glenoid System baseplate and will be determined by using the Kaplan Meier method.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anaverse Shoulder System subjects | – | Device: Anaverse Shoulder SystemSubjects implanted with the Anaverse Shoulder System in the reversed configuration and subjects who underwent total shoulder arthroplasty conversion from anatomical to reversed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from severe shoulder pain and disability indicated for implantation of the Anaverse™ Glenoid System in cases of total shoulder arthroplasty in reversed configuration. Patients who underwent total shoulder arthroplasty conversion from anatomical to reversed will be enrolled for subgroup analysis. Patients must meet all inclusion and none of the exclusion criteria.
Key inclusion criteria (20 listed)
- Patient is 18-75 years of age, inclusive.
- Patient is skeletally mature.
- Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
- Patient must have signed EC-approved informed consent.
- Patient requires a primary reversed total shoulder arthroplasty or a conversion from anatomical to reversed to relieve pain and restore the joint function.
Key exclusion criteria (19 listed)
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient has any condition which would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- Patient has any physical conditions that would impair adequate implant support and/or prevent the use of an appropriately sized implant.
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 |
|---|---|---|
| Anaverse Shoulder SystemReverse Shoulder Arthroplasty | Device | Anaverse Shoulder System subjects |
Primary outcome
Survival of Implant System (Kaplan Meier)
Time frame: 2 years post-op
The primary endpoint of this study is the survival of the implant (Reversed configuration) after 2 years, which is based on removal of the baseplate and will be determined using the Kaplan-Meier method.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Hassan Achakri study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injuries and Shoulder Pain, run by Zimmer Biomet at 1 site in Switzerland.
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 20 inclusion and 19 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 20 Mar 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?
Survival of Implant System (Kaplan Meier) (time frame: 2 years post-op). 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 8 Apr 2025.