Hip ReplacementNCT02230826
Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty
An observational study of Hip Replacement and Primary, Secondary or Post-traumatic Osteoarthrosis, run by Corin at 13 sites in France.
Trial summary
This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis
- How many people
- 2,500 participants
- Where
- 13 sitesFrance
- Study dates
- May 2014to Dec 2044
- 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: Cohort of patients with a partial or total hip replacement (Corin implants)
Who may be able to join
- Man or woman >18 years
- Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study
- Subjects who agreed for study participation.
Who cannot join
- Subjects with existing tumour and/or particularly high surgical risk-
- Subjects with anaesthetic risk class IV or higher
- Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.)
- Contraindications for arthroplasty with a Corin hip devices as per product IFU
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vanessa Grimaud contact
13 sites in 1 country
France13 sites, 6 recruiting
- Active, not recruiting
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33000
- Terminated
clinique Oxford Cannes
Cannes, 06400
- Terminated
CH Dunkerque
Dunkirk, 59385
- Recruiting
Polyclinique Henin Beaumont
Hénin-Beaumont, 62254
Romain GALMICHE, MD
Romain GALMICHE, MD
- Recruiting
CHU de Nice
Nice, 06000
Régis BERNARD DE DOMPSURE, MD
Régis BERNARD DE DOMPSURE, MD
- Terminated
Centre Hospitalier Régionnal d'Orléans - Site La Source
Orléans, 45000
- Terminated
Clinique Arago
Paris, 75014
- Recruiting
Hôpital de la Croix Saint-Simon
Paris, 75020
Antoine MOUTON, MD
Antoine MOUTON, MD
- Active, not recruiting
Hopital privé Saint-Martin
Pessac, 33600
- Recruiting
Hôpital Provo
Roubaix, 59100
François GIRAUD, MD
François GIRAUD, MD
- Recruiting
Polyclinique St Georges de Didonne
Saint-Georges-de-Didonne, 17110
Christine LAUTRIDOU, MD
Christine LAUTRIDOU, MD
- Terminated
Médipôle Garonne
Toulouse, 31000
- Recruiting
Hôpital Jean Bernard
Valenciennes, 59300
Charles BERTON, MD
Charles BERTON, MD
About this study
Official title: Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty
This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.
Read the detailed description
Outcome data collected from this study will be used for Post Market Surveillance (PMS) and Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on products performance and safety at long term follow-up.
- Conditions
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations, Primary and Revision Surgery
- Keywords
- Arthroplasty, Hip Replacement, Acetabular cup, Femoral stem
- Medical subject headings
- Neoplasm Metastasis, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hip arthroplasty | Patients with Hip implants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of long-term outcome after hip arthroplasty with Corin implants.
Implants revision rate at 10-year FU hip arthroplasty
Measured: At 10 years
Secondary outcomes (6)
Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.
Implants revision rate at 15- and 20-year FU.
Measured: at 15- and 20-year
Evaluation of clinical performance of Corin hip implants
Change of Patient Reported Outcome Measures (PROMs)
Measured: starting intraoperatively up to 20-year FU
Evaluation of Safety of Corin hip implants
Number, severity and causal relationship of procedure or implant-related Adverse Events
Measured: starting intraoperatively up to 20-year FU
Radiological evaluation of positioning and osteointegration of Corin hip implants.
Number, thickness and location of radiolucent lines, osteolysis and heterotopic ossifications reported via radiological evaluation
Measured: starting intraoperatively up to 20-year FU
Evaluation of patient quality of life
Improvement of quality of life via EQ-5D-5L scores.
Measured: starting intraoperatively up to 20-year FU
Evaluation of patient satisfaction following surgery
Improvement of patient's satisfaction
Measured: 3 months ; 2.5-year; 6, 11, 15, 20-year visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2034 (estimated)
- Study completionDec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ReplacementStudies 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
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Goulven Rochcongar, MD, Study chair, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230826
- Sponsor's protocol ID
- HIPLTO
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2014
- 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
- Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02230826
- Acronym / sponsor ID
- HIPLTO
- Conditions
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations, Primary and Revision Surgery
- Keywords
- Arthroplasty, Hip Replacement, Acetabular cup, Femoral stem
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2044 (estimated)
- First posted
- 3 Sep 2014 (estimated)
- 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 long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.
Detailed description
Outcome data collected from this study will be used for Post Market Surveillance (PMS) and Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on products performance and safety at long term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Hip arthroplasty | – | –Patients with Hip implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients with a partial or total hip replacement (Corin implants)
Key inclusion criteria (3 listed)
- Man or woman >18 years
- Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study
- Subjects who agreed for study participation.
Key exclusion criteria (4 listed)
- Subjects with existing tumour and/or particularly high surgical risk-
- Subjects with anaesthetic risk class IV or higher
- Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.)
- Contraindications for arthroplasty with a Corin hip devices as per product IFU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of long-term outcome after hip arthroplasty with Corin implants.
Time frame: At 10 years
Implants revision rate at 10-year FU hip arthroplasty
6 secondary outcomes
Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.
Time frame: at 15- and 20-year
Evaluation of clinical performance of Corin hip implants
Time frame: starting intraoperatively up to 20-year FU
Evaluation of Safety of Corin hip implants
Time frame: starting intraoperatively up to 20-year FU
Radiological evaluation of positioning and osteointegration of Corin hip implants.
Time frame: starting intraoperatively up to 20-year FU
Evaluation of patient quality of life
Time frame: starting intraoperatively up to 20-year FU
Evaluation of patient satisfaction following surgery
Time frame: 3 months ; 2.5-year; 6, 11, 15, 20-year visits
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.
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Z1 Hip System: Post-Market Clinical Follow Up Study
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Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
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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.
Vanessa Grimaud contact
Goulven Rochcongar, MD study chair
University Hospital, Caen
13 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 Replacement and Primary, Secondary or Post-traumatic Osteoarthrosis, run by Corin at 13 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 3 inclusion and 4 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 13 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 (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 long-term outcome after hip arthroplasty with Corin implants. (time frame: At 10 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.