Clinical trial NCT02230826: Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty
Official title: Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Replacement
Primary, Secondary or Post-traumatic Osteoarthrosis
Femur Head Necrosis
Congenital Dislocations
Primary and Revision Surgery
Keywords: Arthroplasty
Hip Replacement
Acetabular cup
Femoral stem
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of patients with a partial or total hip replacement (Corin implants)

Brief summary: 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.

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

Primary outcomes:
measure: Evaluation of long-term outcome after hip arthroplasty with Corin implants.
timeFrame: At 10 years
Secondary outcomes:
measure: Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.
timeFrame: at 15- and 20-year
measure: Evaluation of clinical performance of Corin hip implants
timeFrame: starting intraoperatively up to 20-year FU
measure: Evaluation of Safety of Corin hip implants
timeFrame: starting intraoperatively up to 20-year FU
measure: Radiological evaluation of positioning and osteointegration of Corin hip implants.
timeFrame: starting intraoperatively up to 20-year FU
measure: Evaluation of patient quality of life
timeFrame: starting intraoperatively up to 20-year FU
measure: Evaluation of patient satisfaction following surgery
timeFrame: 3 months ; 2.5-year; 6, 11, 15, 20-year visits
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin
city: Cannes
country: France
facility: clinique Oxford Cannes
city: Dunkerque
country: France
facility: CH Dunkerque
city: Hénin-Beaumont
country: France
facility: Polyclinique Henin Beaumont
city: Nice
country: France
facility: CHU de Nice
city: Orléans
country: France
facility: Centre Hospitalier Régionnal d'Orléans - Site La Source
city: Paris
country: France
facility: Clinique Arago
city: Paris
country: France
facility: Hôpital de la Croix Saint-Simon
city: Pessac
country: France
facility: Hopital privé Saint-Martin
city: Roubaix
country: France
facility: Hôpital Provo
city: St Georges de Didonne
country: France
facility: Polyclinique St Georges de Didonne
city: Toulouse
country: France
facility: Médipôle Garonne
city: Valenciennes
country: France
facility: Hôpital Jean Bernard
Study officials:
affiliation: University Hospital, Caen
name: Goulven Rochcongar, MD
role: STUDY_CHAIR
References: