Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem

Active, not recruiting

• Conditions: Hip Arthropathy

• Registration Number: NCT05560022
• Lead Sponsor: Societe dEtude, de Recherche et de Fabrication

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-05
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2031-01-20
• Study Completion: 2031-01-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements	per operative period to 10 years	Survival according to Kaplan Meier

Secondary Outcome Measures

Name	Time	Method
Adverse events	per operative period to 10 years	Type and occurrence of adverse events
Assess the improvement in PMA scores and HHS score as well as patient satisfaction	per operative period to 10 years
Patient satisfaction	per operative period to 10 years

Trial Locations

Locations (1)

CHU de ROUEN; 🇫🇷 Rouen, France