Anaverse™ Glenoid System and Its Instrumentation

NCT05215600 | Terminated Results

• 1 other identifier: CME2017-11E
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Injuries; Shoulder Pain; Arthropathy; Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years post-op

Other Outcomes (3)

• Constant Murley Shoulder Score (CM)

  Pre-operative (baseline), 1 year, 2 years post-operative

• Subjective Shoulder Value (SSV)

  Pre-operative (baseline), 1 year, 2 years post-operative

• Radiographic Parameters

  Immediate post-op to 2 years post-operative

Study Arms (1)

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.

Device: Anaverse Shoulder System

Interventions

Anaverse Shoulder System DEVICE

Reverse Shoulder Arthroplasty

Anaverse Shoulder System subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.
• Unstable fixation of Baseplate after removal of PE Liner.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain; Joint Diseases

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations of this study are the low sample size of 21 cases as well as the short follow-up period of two years.

Results Point of Contact

• Title: Carina Hafner
• Organization: Zimmer Biomet

carina.hafner@zimmerbiomet.com

+41797073093

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: January 31, 2022
• Study Start: May 6, 2022
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: April 8, 2025
• Results First Posted: March 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)