Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant

Trial ID or NCT#

NCT02424760

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Prospective Cohort Study to Document the Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - Acute proximal humeral fracture, - Systemic or local infection, - Rotator cuff tear, - Instability of the humeral head, - Axillary nerve palsy, - Revision arthroplasty.