Hip Arthropathy
Conditions
Keywords
Total hip arthroplasty
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.
Interventions
DEVICETotal hip arthroplasty
Replacement of hip joint
Sponsors
Societe dEtude, de Recherche et de Fabrication
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Safety adverse event | per operative period to at least 2 year | Type and occurence of adverse events |
| 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 |
| Survival rate | per operative period to at least 2 year | Kaplan-Meier survival rates of cups and liners |
Countries
France
Outcome results
None listed