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

Prospective and Observational Study of HYPE SCS Stems

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05524363

Acronym

2020-04

Enrollment

120

Registered

2022-09-01

Start date

2020-10-13

Completion date

2027-03-01

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthropathy

Keywords

Total Hip Prosthesis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Survival rate according to Kaplan-Meier	per operative period to 5 years	whatever the cause of revision

Secondary

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

Countries

France

Outcome results