Clinical trial NCT05524363: Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty
Official title: Prospective and Observational Study of HYPE SCS Stems
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Arthropathy
Keywords: Total Hip Prosthesis
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2022-09-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment of adults patients representing 120 hips operated between 2020 and 2022 (8 patients have been implanted at both hips).

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.


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

Primary outcomes:
measure: Survival rate according to Kaplan-Meier
timeFrame: per operative period to 5 years
Secondary outcomes:
measure: Patient satisfaction
timeFrame: per operative period to 5 years
measure: Adverse events
timeFrame: per operative period to 5 years
measure: Functional improvement
timeFrame: per operative period to 5 years
measure: Functional improvement
timeFrame: per operative period to 5 years
measure: Pain release
timeFrame: per operative period to 5 years
Other outcomes:
Locations:
city: Flers-en-Escrebieux
country: France
facility: Centre hospitalier " J. Monod ",
Study officials:
References: