Education and Training
Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- device: Shoulder hemi-arthroplasty
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Acute proximal humeral fracture,
- Systemic or local infection,
- Rotator cuff tear,
- Instability of the humeral head,
- Axillary nerve palsy,
- Revision arthroplasty.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting