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

Active, not recruiting

• Conditions: Hip Arthropathy

• Registration Number: NCT05524363
• Lead Sponsor: Societe dEtude, de Recherche et de Fabrication

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-13
• 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: 2025-03-18
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate according to Kaplan-Meier	per operative period to 5 years	whatever the cause of revision

Secondary Outcome Measures

Name	Time	Method
Functional improvement	per operative period to 5 years	This information will be documented through patient questionnary Devane classification
Pain release	per operative period to 5 years	This information will be documented through patient questionnary : Harris Hip Score
Adverse events	per operative period to 5 years	Type and occurence of adverse events
Patient satisfaction	per operative period to 5 years	questionnary with a 4 item-scale

Trial Locations

Locations (1)

Centre hospitalier " J. Monod ",; 🇫🇷 Flers-en-Escrebieux, France