WithdrawnNot Applicable

Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem

Stopped: This record is a duplicate. The study is already registered on ClinicalTrials.gov under another NCT number. No participants were enrolled in this duplicate record.

France0Started 2017-12-05

Plain-language summary

The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .

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: * Man or women * Degenerative or inflammatory hip pathology requiring a total hip replacement * Primary or secondary osteoarthritis * Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis * Fracture or avascular necrosis * Sub-capital fracture and displaced transcervical as well as for bone defects stages I to IIb of PAPROSKY * Traumatic joint destruction * Following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty Exclusion Criteria: * People with diminished mental faculties * Known current pregnancy * Breast-feeding * Neurological disorders or other pathologies that may influence locomotion * Septic antecedent on hip to operate * Patient requiring a bone graft

What they're measuring

Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements

Timeframe: per operative period to 10 years

Trial details

NCT IDNCT05560022

SponsorSociete dEtude, de Recherche et de Fabrication

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-01-20