Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05560022

Enrollment

Registered

2022-09-29

Start date

2017-12-05

Completion date

2031-01-20

Last updated

2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthropathy

Keywords

Total Hip Prothesis

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 .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	Type and occurrence of adverse events
Patient satisfaction	per operative period to 10 years	—

Countries

France

Outcome results