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Recruiting NCT05686278

Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

— Observational Hip Fractures Hip Hemiarthroplasty Osteoarthritis, Hip Avascular Necrosis of Hip

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
The protocol lists: Bipolar i and cemented stem (Océane+ or Meije).
Who it may be relevant to
Registry conditions: Hip Fractures, Hip Hemiarthroplasty, Osteoarthritis, Hip, Avascular Necrosis of Hip. 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

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

Overview

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.

Detailed description

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.

Interventions

  • Device Bipolar i and cemented stem (Océane+ or Meije)
    Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint

Primary outcome measures

  • Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery. [Time frame: 2 years]
Secondary outcome measures (6)
  • Evaluation of mid-term and long-term safety of the study devices up to 10 years. [Time frame: 10 years]
  • Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU. [Time frame: 10 years]
  • Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU. [Time frame: 10 years]
  • Radiographic analysis to detect acetabular erosion [Time frame: 2 years]
  • Radiographic analysis to detect femoral stem stability [Time frame: 2 years]
  • Radiographic analysis to detect bipolar head migration [Time frame: 2 years]

Eligibility criteria

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.

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 · 4 centers
  • Ch Amboise — Amboise
  • Polyclinique Henin Beaumont — Hénin-Beaumont
  • Hopital Saint Joseph — Paris
  • Hopital Diaconesses Croix Saint Simon — Paris

Identifiers

NCT: NCT05686278 · CSP2021-05-FR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗