Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

Active, not recruiting

• Conditions: Hip Arthropathy

• Registration Number: NCT05524350
• Lead Sponsor: Societe dEtude, de Recherche et de Fabrication

Brief Summary

The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution.

This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring 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: 2022-08-29
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2031-01-20
• Study Completion: 2031-01-20

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female
• Degenerative or inflammatory hip disease requiring total hip replacement
• Primary or secondary osteoarthritis,
• Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin,
• Avascular fracture or necrosis,
• Displaced subcapital and transcervical fracture as well as PAPROSKY stages I to IIB bone defects.
• Joint destruction of traumatic origin
• Following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty).

Exclusion Criteria

• Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up
• Known pregnancy in progress
• Breastfeeding
• Patient requiring a bone graft
• Neurological disorders or other pathology that may influence locomotion
• History of sepsis in the hip to be operated on
• Short-term vital prognosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate	Per operative period to 10 years	Survival rate for failure at 10 years by studying in particular the intraosseous behaviour of the stem (femoral implant) and of the acetabulum (acetabular or acetabular implant) with the help of radiological examinations: appearance or not of lines, osseointegration, migration, possible loosening, realignment.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	Per operative period to 10 years	The information will be collected from patient through questionnaires to compare preoperatively situtation to last follow-up situtation
Pain release	Per operative period to 10 years	The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation
Functional improvement	Per operative period to 10 years	The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation
Adverse event	Per operative period to 10 years	Type and occurence of adverse events

Trial Locations

Locations (1)

Rouen University Hospital Center; 🇫🇷 Rouen, France