Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
Trial ID or NCT#
The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies. The rotator cuff must be functional. The aim of this study is to prospectively collect data from consecutive series to implement a Post Marketing Surveillance plan.
A Prospective Cohort Study to Document the Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
- - patients requiring a Humeral Head Replacement (HHR) with INSPYRE as per indication of the Instruction For Use:
- - with degenerative indication such as primary Gleno Humeral (GH) osteoarthritis, post-traumatic arthritis, primary and secondary avascular osteonecrosis of the humeral head,
- - presenting a functional rotator cuff,
- - able to return for all scheduled and required study visit;
- - having provided informed Consent about scientific study participation if applicable.
- - Acute proximal humeral fracture,
- - Systemic or local infection,
- - Rotator cuff tear,
- - Instability of the humeral head,
- - Axillary nerve palsy,
- - Revision arthroplasty.
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