Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

Sponsor

Corin (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05686278

Collaborator

(none)

368

Enrollment

Locations

127

Anticipated Duration (Months)

122.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures Hip Hemiarthroplasty Osteoarthritis, Hip Avascular Necrosis of Hip Femoral Neck Fractures	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 Design

Study Type:

Observational

Anticipated Enrollment :

368 participants

Observational Model:

Cohort

Time Perspective:

Other

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2033

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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 mobility from baseline to 10-year FU. [10 years]
Parker Mobility Score
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 measure 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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 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.