Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty
Overview
This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.
Detailed description
Outcome data collected from this study will be used for Post Market Surveillance (PMS) and Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on products performance and safety at long term follow-up.
Primary outcome measures
- Evaluation of long-term outcome after hip arthroplasty with Corin implants. [Time frame: At 10 years]
Secondary outcome measures (6)
- Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU. [Time frame: at 15- and 20-year]
- Evaluation of clinical performance of Corin hip implants [Time frame: starting intraoperatively up to 20-year FU]
- Evaluation of Safety of Corin hip implants [Time frame: starting intraoperatively up to 20-year FU]
- Radiological evaluation of positioning and osteointegration of Corin hip implants. [Time frame: starting intraoperatively up to 20-year FU]
- Evaluation of patient quality of life [Time frame: starting intraoperatively up to 20-year FU]
- Evaluation of patient satisfaction following surgery [Time frame: 3 months ; 2.5-year; 6, 11, 15, 20-year visits]
Eligibility criteria
Inclusion criteria
- Man or woman >18 years
- Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study
- Subjects who agreed for study participation.
Exclusion criteria
- Subjects with existing tumour and/or particularly high surgical risk-
- Subjects with anaesthetic risk class IV or higher
- Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.)
- Contraindications for arthroplasty with a Corin hip devices as per product IFU
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 13 centers
- CHU de Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux
- clinique Oxford Cannes — Cannes
- CH Dunkerque — Dunkirk
- Polyclinique Henin Beaumont — Hénin-Beaumont
- CHU de Nice — Nice
- Centre Hospitalier Régionnal d'Orléans - Site La Source — Orléans
- Clinique Arago — Paris
- Hôpital de la Croix Saint-Simon — Paris
- … and 5 more centers
Identifiers
NCT: NCT02230826 · HIPLTO