UnknownNot Applicable

Aequalis Resurfacing Head Study

100 participantsStarted 2011-04

Plain-language summary

Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007. The aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as prospectively, from a consecutive series of patients to assess the patients' outcomes and functional status.

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * Patient has received an Aequalis® Resurfacing Head implant as per the manufacturer's instructions (including the recommended indication): degenerative indication such as primary osteoarthritis, secondary osteoarthritis (post-traumatic post instability), avascular osteonecrosis of the humeral head ; * with a functional rotator cuff ; * has clinical and radiographic follow-up data available ; * is informed about the study and has provided Informed Consent as applicable. Exclusion Criteria: * Patient with proximal humeral fracture, * previous history of infection, * rotator cuff tear, cuff tear arthropathy, * significant bone loss of the glenoid (more than 25% of the articular surface), * nerve palsy, * revision arthroplasty.

What they're measuring

Implant survival rate

Timeframe: up to 10-year follow-up

Trial details

NCT IDNCT02444299

SponsorStryker Trauma and Extremities

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-04

View on ClinicalTrials.gov More Localized, Primary Osteoarthritis trials