Overview
The Voll Degradable Shoulder Spacer First-in-Human study aims to evaluate the initial safety, effectiveness, and clinical outcomes of a degradable shoulder spacer in over 50 years old patients with symptomatic massive rotator cuff tears (MRCT).
Eligibility
Main Inclusion Criteria:
- Full thickness MRCT.
- Male or female patients ≥ fifty (50) years of age, in general good health, independent, and can comply with all post-operative evaluations and visits.
Main Exclusion Criteria:
- Documented evidence of a history of drug/alcohol abuse within 1 year of enrollment.
- Concurrent participation in any other investigational clinical study.