Trial Search Results

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.

Lead Sponsor:

Tornier, Inc.

Stanford Investigator(s):

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