Hip ArthropathyNCT05524350
Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)
An observational study of Hip Arthropathy, run by Societe dEtude, de Recherche et de Fabrication at 1 site in France.
Trial summary
The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2017to 20 Jan 2031
- 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
- Adult, Older adult
Study population: The expected number of patients in the registry is estimated at 180 patients.The implantation of the total hip prosthesis will be carried out in patients with a hip pathology, in first intention or during a total prosthesis revision. The implant placement will be performed on a continuous series of patients by the investigator according to the eligibility criteria. Post-operative follow-up will be carried out for ten days following the operation, in the hospital concerned. Successive clinical and radiological evaluations will be performed at a date set by the investigator.
Who may be able to join
- Male or female
- Degenerative or inflammatory hip disease requiring total hip replacement
- Primary or secondary osteoarthritis,
- Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin,
- Avascular fracture or necrosis,
- Displaced subcapital and transcervical fracture as well as PAPROSKY stages I to IIB bone defects.
- Joint destruction of traumatic origin
- Following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty).
Who cannot join
- Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up
- Known pregnancy in progress
- Breastfeeding
- Patient requiring a bone graft
- Neurological disorders or other pathology that may influence locomotion
- History of sepsis in the hip to be operated on
- Short-term vital prognosis
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 use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution.
This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.
- Conditions
- Hip Arthropathy
- Keywords
- Total Hip Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Survival rate for failure at 10 years by studying in particular the intraosseous behaviour of the stem (femoral implant) and of the acetabulum (acetabular or acetabular implant) with the help of radiological examinations: appearance or not of lines, osseointegration, migration, possible loosening, realignment.
Measured: Per operative period to 10 years
Secondary outcomes (4)
Functional improvement
The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation
Measured: Per operative period to 10 years
Pain release
The information will be collected through questionnaires to compare preoperatively situtation to last follow-up situtation
Measured: Per operative period to 10 years
Patient satisfaction
The information will be collected from patient through questionnaires to compare preoperatively situtation to last follow-up situtation
Measured: Per operative period to 10 years
Adverse event
Type and occurence of adverse events
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 posted1 Sep 2022
- Study start5 Dec 2017
- Primary completion20 Jan 2031 (estimated)
- Study completion20 Jan 2031 (estimated)
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
- 180 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
- NCT05524350
- Sponsor's protocol ID
- 2017-A03359-44
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 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
- NCT05524350
- Acronym / sponsor ID
- 2017-A03359-44
- Conditions
- Hip Arthropathy
- Keywords
- Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 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
- 1 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 use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution.
This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring 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
- Age groups
- Adult, Older adult
- Study population
- The expected number of patients in the registry is estimated at 180 patients.The implantation of the total hip prosthesis will be carried out in patients with a hip pathology, in first intention or during a total prosthesis revision. The implant placement will be performed on a continuous series of patients by the investigator according to the eligibility criteria. Post-operative follow-up will be carried out for ten days following the operation, in the hospital concerned. Successive clinical and radiological evaluations will be performed at a date set by the investigator.
Key inclusion criteria (8 listed)
- Male or female
- Degenerative or inflammatory hip disease requiring total hip replacement
- Primary or secondary osteoarthritis,
- Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin,
- Avascular fracture or necrosis,
Key exclusion criteria (7 listed)
- Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up
- Known pregnancy in progress
- Breastfeeding
- Patient requiring a bone graft
- Neurological disorders or other pathology that may influence locomotion
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
Survival rate
Time frame: Per operative period to 10 years
Survival rate for failure at 10 years by studying in particular the intraosseous behaviour of the stem (femoral implant) and of the acetabulum (acetabular or acetabular implant) with the help of radiological examinations: appearance or not of lines, osseointegration, migration, possible loosening, realignment.
4 secondary outcomes
Functional improvement
Time frame: Per operative period to 10 years
Pain release
Time frame: Per operative period to 10 years
Patient satisfaction
Time frame: Per operative period to 10 years
Adverse event
Time frame: Per operative period to 10 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 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 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: under way, not looking for participants, 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?
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?
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?
Survival rate (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.