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NCT Number: NCT02230826

Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty

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

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Key information

Conditions

Hip Replacement Bone Diseases Congenital Dislocations Femur Head Necrosis Musculoskeletal Diseases Necrosis Neoplasm Metastasis Neoplasms Neoplastic Processes Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Primary and Revision Surgery Primary, Secondary or Post-traumatic Osteoarthrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux - Groupe Hospitalier Pellegrin, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of long-term outcome after hip arthroplasty with Corin implants.

    Time frame: At 10 years

    Implants revision rate at 10-year FU hip arthroplasty

Secondary outcomes

  1. Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.

    Time frame: at 15- and 20-year

    Implants revision rate at 15- and 20-year FU.

  2. Evaluation of clinical performance of Corin hip implants

    Time frame: starting intraoperatively up to 20-year FU

    Change of Patient Reported Outcome Measures (PROMs)

  3. Evaluation of Safety of Corin hip implants

    Time frame: starting intraoperatively up to 20-year FU

    Number, severity and causal relationship of procedure or implant-related Adverse Events

  4. Radiological evaluation of positioning and osteointegration of Corin hip implants.

    Time frame: starting intraoperatively up to 20-year FU

    Number, thickness and location of radiolucent lines, osteolysis and heterotopic ossifications reported via radiological evaluation

  5. Evaluation of patient quality of life

    Time frame: starting intraoperatively up to 20-year FU

    Improvement of quality of life via EQ-5D-5L scores.

  6. Evaluation of patient satisfaction following surgery

    Time frame: 3 months ; 2.5-year; 6, 11, 15, 20-year visits

    Improvement of patient's satisfaction

Study contacts

Contact information is provided by the study sponsor or research team.

Vanessa Grimaud

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Corin

Industry

Registry information

Official study title

Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty

Important dates

Study start
2014
Primary completion
2034
Study completion
2044
First posted
Sep 3, 2014
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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