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

Hip Arthropathy Clinical Trial

— 2020-04  

Official title:

Prospective and Observational Study of HYPE SCS Stems

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05524363
• Other study ID #: 2020-04-AMELINE_HYPE_SCS
• Status: Active, not recruiting
• Start date: October 13, 2020
• Est. completion date: March 1, 2027

Study information

• Verified date: October 2023
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Locations

Country	Name	City	State
France	Centre hospitalier " J. Monod ",	Flers-en-Escrebieux

Sponsors (1)

Lead Sponsor	Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate according to Kaplan-Meier	whatever the cause of revision	per operative period to 5 years
Secondary	Patient satisfaction	questionnary with a 4 item-scale	per operative period to 5 years
Secondary	Adverse events	Type and occurence of adverse events	per operative period to 5 years
Secondary	Functional improvement	This information will be documented through patient questionnary Harris Hip Score	per operative period to 5 years
Secondary	Functional improvement	This information will be documented through patient questionnary Devane classification	per operative period to 5 years
Secondary	Pain release	This information will be documented through patient questionnary : Harris Hip Score	per operative period to 5 years