Hip ArthropathyNCT06465940
Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
An observational study of Hip Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
Trial summary
This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER). Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2020to 7 Jul 2020
- 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: Patient implanted in the selected investigational site with a HYPE® acetabular cup and HIPER liner between 2016 and 2018 were identified. The following selection criteria were used.
Who may be able to join
- Patient was an adult at surgery,
- Patient implanted with HYPE® acetabular cup and HIPER liner,
- Patient was followed-up at least once on retrospective part of the study,
- Patient's current social security affiliation is valid.
Who cannot join
- Patient refuses the use of his/her personal data,
- Patient is unable to follow surgeon's instruction or unavailable for follow-up,
- Patient with contraindication to x-rays,
- Patient not implanted with HYPE® acetabular cup and HIPER liner.
Trial locations and contacts
1 site in 1 country.
About this study
This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).
Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.
- Conditions
- Hip Arthropathy
- Being tested
- Total hip arthroplasty
- Keywords
- Total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyDevice
Replacement of hip joint
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional score
The information will be collected through questionnaires to compare preoperatively situation to last follow-up situation
Measured: per operative period to at least 2 year
Secondary outcomes (3)
Patient satisfaction
The information will be collected from patient through questionnaires to compare preoperatively situation to last follow-up situation
Measured: per operative period to at least 2 year
Safety adverse event
Type and occurence of adverse events
Measured: per operative period to at least 2 year
Survival rate
Kaplan-Meier survival rates of cups and liners
Measured: per operative period to at least 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start3 Jul 2020
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies 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
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe dEtude, de Recherche et de Fabrication
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465940
- Sponsor's protocol ID
- 2020-05
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
- ClinicalTrials.gov ID
- NCT06465940
- Acronym / sponsor ID
- 2020-05
- Conditions
- Hip Arthropathy
- Keywords
- Total hip arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 20 Jun 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 study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).
Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient implanted in the selected investigational site with a HYPE® acetabular cup and HIPER liner between 2016 and 2018 were identified. The following selection criteria were used.
Key inclusion criteria (4 listed)
- Patient was an adult at surgery,
- Patient implanted with HYPE® acetabular cup and HIPER liner,
- Patient was followed-up at least once on retrospective part of the study,
- Patient's current social security affiliation is valid.
Key exclusion criteria (4 listed)
- Patient refuses the use of his/her personal data,
- Patient is unable to follow surgeon's instruction or unavailable for follow-up,
- Patient with contraindication to x-rays,
- Patient not implanted with HYPE® acetabular cup and HIPER liner.
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 arthroplastyReplacement of hip joint | Device | – |
Primary outcome
Functional score
Time frame: per operative period to at least 2 year
The information will be collected through questionnaires to compare preoperatively situation to last follow-up situation
3 secondary outcomes
Patient satisfaction
Time frame: per operative period to at least 2 year
Safety adverse event
Time frame: per operative period to at least 2 year
Survival rate
Time frame: per operative period to at least 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arthropathy, run by Societe dEtude, de Recherche et de Fabrication 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 4 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: finished, as of the sponsor's last update on 20 Jun 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional score (time frame: per operative period to at least 2 year). 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 20 Jun 2024.