Shoulder Pain Clinical Trial
Official title:
Anaverse™ Glenoid System and Its Instrumentation - Retrospective and Prospective, Non-Controlled Post Market Clinical Follow-Up Study
NCT number | NCT05215600 |
Other study ID # | CME2017-11E |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | May 6, 2022 |
Est. completion date | April 23, 2024 |
Verified date | May 2024 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 21 |
Est. completion date | April 23, 2024 |
Est. primary completion date | April 23, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. 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. Exclusion criteria: - 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. 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Balgrist University Hospital | Zurich |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prosthesis survival | 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 |
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