Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

Recruiting

• Conditions: Femoral Neck Fractures; Hip Fractures; Osteoarthritis, Hip; Avascular Necrosis of Hip; Hip Hemiarthroplasty
• Interventions: Device: Bipolar i and cemented stem (Océane+ or Meije)

• Registration Number: NCT05686278
• Lead Sponsor: Corin

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-17
• Study Start: 2023-06-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-09
• Study Completion: 2033-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

1. Both genders.
2. Adult subjects.
3. 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.
4. The subject is willing to comply with the required follow-up visits as per protocol.
5. The subject has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.

Exclusion Criteria

1. Subjects with active infection or sepsis or osteomyelitis.
2. Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis.
3. Subject with marked bone loss or bone absorption.
4. Subject with metabolic disorders which may impair bone formation or bone quality.
5. Subjects under guardianship.
6. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+)	Bipolar i and cemented stem (Océane+ or Meije)	Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices

Primary Outcome Measures

Name	Time	Method
Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery.	2 years	Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.

Secondary Outcome Measures

Name	Time	Method
Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.	10 years	Parker Mobility Score
Evaluation of mid-term and long-term safety of the study devices up to 10 years.	10 years	Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.
Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.	10 years	EQ5D-5L
Radiographic analysis to detect acetabular erosion	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.
Radiographic analysis to detect femoral stem stability	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.
Radiographic analysis to detect bipolar head migration	2 years	Bipolar head migration measured comparing immediate post operative X Rays (baseline) to 2 years

Trial Locations

Locations (3)

Ch Amboise; 🇫🇷 Amboise, France

Polyclinique Henin Beaumont; 🇫🇷 Henin Beaumont, France

Hopital Saint Joseph; 🇫🇷 Paris, France