Hip ArthritisNCT06518993
Observational Study to Collect Safety Data and PROMs on Primary THA
An observational study of Hip Arthritis and Osteoarthritis, Hip, run by Corin at 1 site in France.
Trial summary
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthritis, Osteoarthritis, Hip, Coxitis
- What is being tested?
- Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2024to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who have undergone to a THA with Trinity cup and Meije Duo cementless hip will be invited to participate in this study. An initial review of the medical database of all Corin Trinity cup procedures performed in the selected study site will be conducted to assess the number of retrospective patients potentially available to join the study. A first contact with the patient will occur telephonically or via mail to explain the study and invite them to join.
Who may be able to join
- Both genders.
- Adult subjects.
- Subjects who received a primary THR with Trinity cup and Meije Duo cementless femoral stem.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Collect Safety Data and Patient-reported Outcomes Measures (PROMs) on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
Read the detailed description
The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA).
Data collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.
- Conditions
- Hip Arthritis, Osteoarthritis, Hip, Coxitis, Femoral Head Necrosis, Femoral Neck Fractures
- Being tested
- Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
- Keywords
- total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stemDevice
Subjects clinically suitable for a primary THR surgery with Trinity cup and Meije Duo cementless femoral stem.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of hip functional performance
Improvement of Oxford Hip Score (OHS)
Measured: 2 years
Secondary outcomes (5)
Confirmation of safety of the study devices
Number, severity and causal relationship procedure of implant-related adverse events
Measured: 2 years
Evaluation of outcome after hip arthroplasty
Number, severity and causal relationship procedure of implant-related adverse events
Measured: 2 years
Evaluation of clinical outcomes
Improvement of Harris Hip Score (HHS)
Measured: 2 years
Assessment of health-related quality of life
Change of EQ-5D-5L
Measured: 2 years
Assessment of patient's satisfaction
Improvement of patient's satisfaction following surgery using Self-Administered Patient Satisfaction Scale
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 posted25 Jul 2024
- Study start19 Apr 2024
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Why it stopped: The current study was prematurely terminated as part of a strategic decision to consolidate resources and incorporate the Trinity implant into another ongoing PMCF study which was initiated to meet updated regulatory requirements.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies 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
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles BERTON, MD, Principal investigator, CH VALENCIENNES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518993
- Sponsor's protocol ID
- CSP2022-04
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Collect Safety Data and Patient-reported Outcomes Measures (PROMs) on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem
- ClinicalTrials.gov ID
- NCT06518993
- Acronym / sponsor ID
- CSP2022-04
- Conditions
- Hip Arthritis, Osteoarthritis, Hip, Coxitis, Femoral Head Necrosis, Femoral Neck Fractures
- Keywords
- total hip arthroplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The current study was prematurely terminated as part of a strategic decision to consolidate resources and incorporate the Trinity implant into another ongoing PMCF study which was initiated to meet updated regulatory requirements.
- Enrolment
- 116 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 25 Jul 2024 (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 observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
Detailed description
The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA).
Data collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone to a THA with Trinity cup and Meije Duo cementless hip will be invited to participate in this study. An initial review of the medical database of all Corin Trinity cup procedures performed in the selected study site will be conducted to assess the number of retrospective patients potentially available to join the study. A first contact with the patient will occur telephonically or via mail to explain the study and invite them to join.
Key inclusion criteria (5 listed)
- Both genders.
- Adult subjects.
- Subjects who received a primary THR with Trinity cup and Meije Duo cementless femoral stem.
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stemSubjects clinically suitable for a primary THR surgery with Trinity cup and Meije Duo cementless femoral stem. | Device | – |
Primary outcome
Evaluation of hip functional performance
Time frame: 2 years
Improvement of Oxford Hip Score (OHS)
5 secondary outcomes
Confirmation of safety of the study devices
Time frame: 2 years
Evaluation of outcome after hip arthroplasty
Time frame: 2 years
Evaluation of clinical outcomes
Time frame: 2 years
Assessment of health-related quality of life
Time frame: 2 years
Assessment of patient's satisfaction
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The current study was prematurely terminated as part of a strategic decision to consolidate resources and incorporate the Trinity implant into another ongoing PMCF study which was initiated to meet updated regulatory requirements.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Charles BERTON, MD principal investigator
CH VALENCIENNES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthritis and Osteoarthritis, Hip, run by Corin at 1 site 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 2 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: stopped early, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: The current study was prematurely terminated as part of a strategic decision to consolidate resources and incorporate the Trinity implant into another ongoing PMCF study which was initiated to meet updated regulatory requirements.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of hip functional performance (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 9 Jul 2025.