Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

Hip Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686278
• Other study ID #: CSP2021-05-FR
• Status: Recruiting
• Start date: June 29, 2023
• Est. completion date: September 2033

Study information

• Verified date: August 2023
• Source: Corin
• Contact: Vanessa GRIMAUD
• Phone: 0667267075
• Email: vanessa.grimaud[@]coringroup.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: September 2033
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures
• Hip Hemiarthroplasty
• Necrosis
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
France	Polyclinique Henin Beaumont	Henin Beaumont
France	Hopital Saint Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.	Parker Mobility Score	10 years
Secondary	Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.	EQ5D-5L	10 years
Secondary	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
Secondary	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