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Clinical Trials in France / NCT05524363
Active, not recruiting Observational

Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty

NCT05524363 · tracked via the Priya Life Science France tracker
Sponsor
Societe dEtude, de Recherche et de Fabrication
Phase
Observational
Started
2020-10-13
Last updated
2026-04-22

Condition(s) studied

Hip Arthropathy

Study summary

Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures.

HYPE SCS stems are intended to be used for primary total hip arthroplasties to reduce pain and restore joint mobility of the hip.

Clinical data for HYPE SCS available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.

Thus, in order to maintain compliance with the EU regulation (2017/745) relating to medical devices and following MEDDEV 2.7.1.guidelines, SERF has set up post-market clinical follow-ups (PMCF). This PMCF study aims to generate clinical data in order to confirm these performance of HYPE SCS Stem associated to NOVAE Sunfit TH acetabular cup. In the meantime, through complications faced over the entire period of the study, risks related to the implantation of HYPE SCS stems will be assessed at medium term (5 years). It should be noted that this patient cohort reflects the usual medical care of Hospital Center "J. Monod" of Flers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients over 18 years old. * Patients covered by health insurance system * Patients requiring a total hip arthroplasty, implanted swith a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup Exclusion Criteria: * Patient who expressed opposition to participation in the study and to the use of his personal data * Patient unable to understand surgeon's instructions and meet follow-ups requirements * Patient presenting a contraindication indicated in the IFU of both implantsw * Patient presenting a contraindication to have an X-ray * Patients implanted with a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup, in context of off-label use

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre hospitalier " J. Monod ", Flers-en-Escrebieux France

More Societe dEtude, de Recherche et de Fabrication trials in France

Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants Recruiting
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison Recruiting
Hip Prospective Study Recruiting
Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH) Active, not recruiting
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups Recruiting

Other trials for the same condition

Post Market Clinical Follow-up of EUROSTEM Femoral Stem Active, not recruiting
Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE Active, not recruiting
Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup Active, not recruiting
Hip Prospective Study Recruiting
Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05524363 on ClinicalTrials.gov ↗ ← All trials in France