NCT05524363

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
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Societe dEtude, de Recherche et de Fabrication · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Hip Arthropathy

Timeline

• Start date: 2020-10-13
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2022-09-01
• Last updated: 2025-03-18

Locations

1 site across 1 country: France