Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 368

Contacts and Locations

• Study Contact: Name: Vanessa GRIMAUD; Phone Number: 0667267075; Email: vanessa.grimaud@coringroup.com

Study Locations

• France
  • Henin Beaumont, France, 62110
    • Not yet recruiting
    • Polyclinique Henin Beaumont
    • Principal Investigator: Pierre CHOLEWINSKI, MD
    • Principal Investigator: Romain GALMICHE, MD
    • Contact: Romain GALMICHE, MD; Phone Number: 0321133000
  • Paris, France, 75014
    • Recruiting
    • Hopital Saint Joseph
    • Contact: Peter UPEX, MD; Email: pupex@ghpsj.fr
    • Principal Investigator: Peter UPEX, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+); Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices	Device: Bipolar i and cemented stem (Océane+ or Meije); Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of mid-term and long-term safety of the study devices up to 10 years.	Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.	10 years
Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.	Parker Mobility Score	10 years
Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.	EQ5D-5L	10 years
Radiographic analysis to detect acetabular erosion	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.	2 years
Radiographic analysis to measure femoral stem stability	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.	2 years

Collaborators and Investigators

• Sponsor: Corin
• Investigators: Study Chair: Christophe HULET, MD, PhD, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2033

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hemiarthroplasty; Acetabulum; Hip Fractures
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Femoral Fractures; Hip Injuries; Osteoarthritis; Necrosis; Fractures, Bone; Hip Fractures; Osteoarthritis, Hip; Femoral Neck Fractures
• Other Study ID Numbers: CSP2021-05-FR