Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty

Societe dEtude, de Recherche et de Fabrication2 sites in 1 country180 target enrollmentDecember 5, 2017

ConditionsHip Arthropathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hip Arthropathy
Sponsor: Societe dEtude, de Recherche et de Fabrication
Enrollment: 180
Locations: 2
Primary Endpoint: Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements
Status: Withdrawn
Last Updated: 8 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 .

Registry

clinicaltrials.gov

Start Date

December 5, 2017

End Date

January 20, 2031

Last Updated

8 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Societe dEtude, de Recherche et de Fabrication

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: per operative period to 10 years

Survival according to Kaplan Meier

Secondary Outcomes

Assess the improvement in PMA scores and HHS score as well as patient satisfaction(per operative period to 10 years)
Adverse events(per operative period to 10 years)
Patient satisfaction(per operative period to 10 years)