Trials / Active Not Recruiting
Active Not RecruitingNCT05560022
Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem
Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 180 (actual)
- Sponsor
- Societe dEtude, de Recherche et de Fabrication · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .
Conditions
Timeline
- Start date
- 2017-12-05
- Primary completion
- 2031-01-20
- Completion
- 2031-01-20
- First posted
- 2022-09-29
- Last updated
- 2024-07-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05560022. Inclusion in this directory is not an endorsement.