Clinical trial NCT05686278: Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Fractures
Hip Hemiarthroplasty
Osteoarthritis, Hip
Avascular Necrosis of Hip
Femoral Neck Fractures
Keywords: Hemiarthroplasty
Acetabulum
Hip Fractures
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery.
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of mid-term and long-term safety of the study devices up to 10 years.
timeFrame: 10 years
measure: Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.
timeFrame: 10 years
measure: Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.
timeFrame: 10 years
measure: Radiographic analysis to detect acetabular erosion
timeFrame: 2 years
measure: Radiographic analysis to detect femoral stem stability
timeFrame: 2 years
measure: Radiographic analysis to detect bipolar head migration
timeFrame: 2 years
Other outcomes:
Locations:
city: Amboise
country: France
facility: Ch Amboise
city: Henin Beaumont
country: France
facility: Polyclinique Henin Beaumont
city: Paris
country: France
facility: Hopital Saint Joseph
Study officials:
affiliation: University Hospital, Caen
name: Christophe HULET, MD, PhD
role: STUDY_CHAIR
References: