UnknownNot Applicable

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

67 participantsStarted 2011-03

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Implants survival rates

Timeframe: up to 10 years follow-up

Trial details

NCT IDNCT02424760

SponsorStryker Trauma and Extremities

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-03

View on ClinicalTrials.gov More Localized, Primary Osteoarthritis trials