Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty (2020-04)

Study Research and Manufacturing Company (SERF)

Status: Active, not recruiting

Conditions: Hip Arthropathy

Study type: Observational

Funder types: Industry

Identifiers

NCT05524363

2020-04-AMELINE_HYPE_SCS

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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