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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.
Full 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.
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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:
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:
Exclusion criteria
Specific exclusion criteria for Conversion from Anatomical to Reversed Configuration:
20 participants in 1 patient group
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Central trial contact
Carina Hafner; Lisa To
Data sourced from clinicaltrials.gov
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