Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

NCT05686278 | Recruiting

• 1 other identifier: CSP2021-05-FR
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 4

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.

Conditions

Avascular Necrosis of Hip; Femoral Neck Fractures; Hip Fractures; Hip Hemiarthroplasty; Osteoarthritis, Hip

Keywords

Hemiarthroplasty; Acetabulum; Hip Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  10 years

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

  10 years

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

  10 years

• Radiographic analysis to detect acetabular erosion

  2 years

• Radiographic analysis to detect femoral stem stability

  2 years

Study Arms (1)

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)

Interventions

Bipolar i and cemented stem (Océane+ or Meije) DEVICE

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

Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corin: lead

Study Sites (4)

Ch Amboise

Amboise, France, 37403, France

RECRUITING

Polyclinique Henin Beaumont

Hénin-Beaumont, 62110, France

TERMINATED

Hopital Saint Joseph

Paris, 75014, France

RECRUITING

Hopital Diaconesses Croix Saint Simon

Paris, 75020, France

NOT YET RECRUITING

MeSH Terms

Conditions

Hip Fractures; Osteoarthritis, Hip; Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christophe HULET, MD, PhD

  University Hospital, Caen

  STUDY CHAIR

Central Study Contacts

Vanessa GRIMAUD

CONTACT

0667267075; vanessa.grimaud@coringroup.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: June 29, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2035
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (4)