Hip ArthropathyNCT05560022
Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem
An observational study of Hip Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
Trial summary
The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2017to 20 Jan 2031
- 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: The implantation of the total hip prothesis will be performed in patients with a hip pathology in the first intention or during total prothesis revision
Who may be able to join
- Man or women
- Degenerative or inflammatory hip pathology requiring a total hip replacement
- Primary or secondary osteoarthritis
- Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis
- Fracture or avascular necrosis
- Sub-capital fracture and displaced transcervical as well as for bone defects stages I to IIb of PAPROSKY
- Traumatic joint destruction
- Following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty
Who cannot join
- People with diminished mental faculties
- Known current pregnancy
- Breast-feeding
- Neurological disorders or other pathologies that may influence locomotion
- Septic antecedent on hip to operate
- Patient requiring a bone graft
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .
- Conditions
- Hip Arthropathy
- Keywords
- Total Hip Prothesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements
Survival according to Kaplan Meier
Measured: per operative period to 10 years
Secondary outcomes (3)
Assess the improvement in PMA scores and HHS score as well as patient satisfaction
Measured: per operative period to 10 years
Adverse events
Type and occurrence of adverse events
Measured: per operative period to 10 years
Patient satisfaction
Measured: per operative period to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start5 Dec 2017
- Primary completion20 Jan 2031 (estimated)
- Study completion20 Jan 2031 (estimated)
Why it stopped: This record is a duplicate. The study is already registered on ClinicalTrials.gov under another NCT number. No participants were enrolled in this duplicate record.
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
- Prospective
- Enrolment
- 0 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
- NCT05560022
- Sponsor's protocol ID
- 2017-01-NH-HYPE-Novae
- Status last verified
- Apr 2026
- First submitted
- 26 Sep 2022
- Last updated
- 24 Apr 2026
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05560022
- Acronym / sponsor ID
- 2017-01-NH-HYPE-Novae
- Conditions
- Hip Arthropathy
- Keywords
- Total Hip Prothesis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This record is a duplicate. The study is already registered on ClinicalTrials.gov under another NCT number. No participants were enrolled in this duplicate record.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Societe dEtude, de Recherche et de FabricationIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 20 Jan 2031 (estimated)
- Study completion
- 20 Jan 2031 (estimated)
- First posted
- 29 Sep 2022 (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.
The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The implantation of the total hip prothesis will be performed in patients with a hip pathology in the first intention or during total prothesis revision
Key inclusion criteria (8 listed)
- Man or women
- Degenerative or inflammatory hip pathology requiring a total hip replacement
- Primary or secondary osteoarthritis
- Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis
- Fracture or avascular necrosis
Key exclusion criteria (6 listed)
- People with diminished mental faculties
- Known current pregnancy
- Breast-feeding
- Neurological disorders or other pathologies that may influence locomotion
- Septic antecedent on hip to operate
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
Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements
Time frame: per operative period to 10 years
Survival according to Kaplan Meier
3 secondary outcomes
Assess the improvement in PMA scores and HHS score as well as patient satisfaction
Time frame: per operative period to 10 years
Adverse events
Time frame: per operative period to 10 years
Patient satisfaction
Time frame: per operative period to 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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 8 inclusion and 6 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: withdrawn, as of the sponsor's last update on 24 Apr 2026. 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 withdrawn before enrolling participants, so there are no results.
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?
Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements (time frame: per operative period to 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 24 Apr 2026.