Prospective and Observational Study of HYPE SCS Stems
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Arthropathy
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Survival rate according to Kaplan-Meier
- Status
- Active, not recruiting
- Last Updated
- 10 days ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Survival rate according to Kaplan-Meier
Time Frame: per operative period to 5 years
whatever the cause of revision
Secondary Outcomes
- Pain release(per operative period to 5 years)
- Adverse events(per operative period to 5 years)
- Patient satisfaction(per operative period to 5 years)
- Functional improvement(per operative period to 5 years)