Hip FracturesNCT05686278
Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty
An observational study of Hip Fractures and Hip Hemiarthroplasty, run by Corin at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Hip Hemiarthroplasty, Osteoarthritis, Hip
- What is being tested?
- Bipolar i and cemented stem (Océane+ or Meije)
- Type of treatment
- Medical device
- How many people
- 368 participants
- Where
- 4 sitesFrance
- Study dates
- 29 Jun 2023to Sep 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 3 recruiting
- Recruiting
Ch Amboise
Amboise, France, 37403
Vincent NOEL, MD, 0247233333
Vincent NOEL, MD
- Terminated
Polyclinique Henin Beaumont
Hénin-Beaumont, 62110
- Recruiting
Hopital Saint Joseph
Paris, 75014
Peter UPEX, MD, pupex@ghpsj.fr
Peter UPEX, MD
- Not yet recruiting
Hopital Diaconesses Croix Saint Simon
Paris, 75020
Guillaume AUBERGER, MD, 01 44 64 17 94, gauberger@hopital-dcss.org
Guillaume AUBERGER, MD
About this study
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
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.
Read the 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.
- Conditions
- Hip Fractures, Hip Hemiarthroplasty, Osteoarthritis, Hip, Avascular Necrosis of Hip, Femoral Neck Fractures
- Being tested
- Bipolar i and cemented stem (Océane+ or Meije)
- Keywords
- Hemiarthroplasty, Acetabulum, Hip Fractures
- Medical subject headings
- Hip Fractures, Osteoarthritis, Hip, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar i and cemented stem (Océane+ or Meije)Device
Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint
| Study group | Role | What they receive |
|---|---|---|
| Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+) | Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices Receives: Device: Bipolar i and cemented stem (Océane+ or Meije) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 10 years
Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.
Parker Mobility Score
Measured: 10 years
Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.
EQ5D-5L
Measured: 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.
Measured: 2 years
Radiographic analysis to detect 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.
Measured: 2 years
Radiographic analysis to detect bipolar head migration
Bipolar head migration measured comparing immediate post operative X Rays (baseline) to 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start29 Jun 2023
- Primary completionSep 2028 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe HULET, MD, PhD, Study chair, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686278
- Sponsor's protocol ID
- CSP2021-05-FR
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05686278
- Acronym / sponsor ID
- CSP2021-05-FR
- Conditions
- Hip Fractures, Hip Hemiarthroplasty, Osteoarthritis, Hip, Avascular Necrosis of Hip, Femoral Neck Fractures
- Keywords
- Hemiarthroplasty, Acetabulum, Hip Fractures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+) | – | Device: Bipolar i and cemented stem (Océane+ or Meije)Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar i and cemented stem (Océane+ or Meije)Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint | Device | Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+) |
Primary outcome
Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery.
Time frame: 2 years
Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.
6 secondary outcomes
Evaluation of mid-term and long-term safety of the study devices up to 10 years.
Time frame: 10 years
Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.
Time frame: 10 years
Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.
Time frame: 10 years
Radiographic analysis to detect acetabular erosion
Time frame: 2 years
Radiographic analysis to detect femoral stem stability
Time frame: 2 years
Radiographic analysis to detect bipolar head migration
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Hip Fractures
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
RecruitingObservational study
Pelvic and Acetabular Fracture: A Prospective Observational Study
Pelvic Fracture, Acetabular Fracture
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
Not yet recruitingObservational study
Mortality and Predictors of In-hospital Mortality Among Geriatric Patients With Hip Fracture
Hip Fractures, In-hospital Mortality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe HULET, MD, PhD study chair
University Hospital, Caen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Hip Hemiarthroplasty, run by Corin at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanessa GRIMAUD (0667267075, vanessa.grimaud@coringroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.