Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
- Conditions
- Hip Arthropathy
- Registration Number
- NCT06465940
- Lead Sponsor
- Societe dEtude, de Recherche et de Fabrication
- Brief Summary
This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).
Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Patient was an adult at surgery,
- Patient implanted with HYPE® acetabular cup and HIPER liner,
- Patient was followed-up at least once on retrospective part of the study,
- Patient's current social security affiliation is valid.
- Patient refuses the use of his/her personal data,
- Patient is unable to follow surgeon's instruction or unavailable for follow-up,
- Patient with contraindication to x-rays,
- Patient not implanted with HYPE® acetabular cup and HIPER liner.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional score per operative period to at least 2 year The information will be collected through questionnaires to compare preoperatively situation to last follow-up situation
- Secondary Outcome Measures
Name Time Method Patient satisfaction per operative period to at least 2 year The information will be collected from patient through questionnaires to compare preoperatively situation to last follow-up situation
Safety adverse event per operative period to at least 2 year Type and occurence of adverse events
Survival rate per operative period to at least 2 year Kaplan-Meier survival rates of cups and liners
Trial Locations
- Locations (1)
Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, France