Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

Corin

Status: Enrolling

Conditions: Primary and Revision Surgery; Congenital Dislocations; Primary, Secondary or Post-traumatic Osteoarthrosis; Hip Replacement; Femur Head Necrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02230826

1302-T-HIPLTO-RM

Details and patient eligibility

About

This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 1 patient group

Patients with Hip arthroplasty

Description:

Patients with Hip implants.