Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

Study Research and Manufacturing Company (SERF)

Status: Completed

Conditions: Hip Arthropathy

Treatments: Device: Total hip arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT06465940

2020-05

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.