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NCT Number: NCT05686278

Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Amboise, Amboise, France

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About this study

As part of the current clinical remediation work under the new Medical Device Regulation (MDR), limited data have been identified to support the hemiarthroplasty indication for some of Corin femoral stems. Therefore, this PMCF study has been implemented to collect safety and performance data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Both genders.
  • Adult subjects.
  • Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices based on physical examination, medical history and diagnosis such as: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, revision of failed partial hip replacements in which the acetabulum does not require replacement.
  • The subject is willing to comply with the required follow-up visits as per protocol.
  • The subject, or a designated trusted person in case the subject is unable to do, has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.

Exclusion criteria

  • Subjects with active infection or sepsis or osteomyelitis.
  • Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis.
  • Subject with marked bone loss or bone absorption.
  • Subject with metabolic disorders which may impair bone formation or bone quality.
  • Subjects under guardianship.
  • Subjects under jusicial protection
  • Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.

Treatment and study plan

Bipolar i and cemented stem (Océane+ or Meije)

Device

Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint

Primary outcomes

  1. Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery.

    Time frame: 2 years

    Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.

Secondary outcomes

  1. Evaluation of mid-term and long-term safety of the study devices up to 10 years.

    Time frame: 10 years

    Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.

  2. Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.

    Time frame: 10 years

    Parker Mobility Score

  3. Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.

    Time frame: 10 years

    EQ5D-5L

  4. Radiographic analysis to detect acetabular erosion

    Time frame: 2 years

    Acetabular erosion measured comparing immediate post-operative X-rays (baseline) to 2-year follow up and classified according to the criteria of Baker et al.

  5. Radiographic analysis to detect femoral stem stability

    Time frame: 2 years

    Femoral stem stability measured on weight-bearing AP and lateral X-rays as rate of continuous, progressive and symptomatic periprosthetic radiolucent lines greater than 2mm using the zonal classification described by Gruen et al. from immediate postoperative (baseline) to 2-year follow up.

  6. Radiographic analysis to detect bipolar head migration

    Time frame: 2 years

    Bipolar head migration measured comparing immediate post operative X Rays (baseline) to 2 years

Study contacts

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

Vanessa GRIMAUD

CONTACT

[email protected]

0667267075

Sponsors and collaborators

Lead sponsor

Corin

Industry

Registry information

Official study title

A Post-market Clinical Follow-up (PMCF) Study to Evaluate Clinical, Radiographic and Patient Reported Outcomes Following a Hip Hemiarthroplasty Surgery Using Corin Devices

Important dates

Study start
2023
Primary completion
2028
Study completion
2035
First posted
Jan 17, 2023
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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