Osteoarthritis, HiphypeNCT03500926
Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
A study testing total hip replacement - standard femoral stem and total hip replacement - short femoral stem in people with Osteoarthritis, Hip, run by Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique at 1 site in France.
Trial summary
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- total hip replacement - standard femoral stem and total hip replacement - short femoral stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2018to 9 Mar 2025
- Phase
- Interventional
- 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
Who may be able to join
- hip osteoarthritis requiring a total hip replacement
- >18 years old
- agrees to participate
Who cannot join
- total hip replacement not indicated
- general anesthesia contraindicated
- previous surgery on the ipsilateral femur
- follow-up not possible
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Cochin
Paris, Île-de-France Region, 75014
David J Biau, MD, +331 58 41 30 37, secretariat.biau.cch@aphp.fr
About this study
Official title: Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
Read the detailed description
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.
- Conditions
- Osteoarthritis, Hip
- Being tested
- total hip replacement - standard femoral stem, total hip replacement - short femoral stem
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip replacement - standard femoral stemDevice
total hip replacement with standard femoral stem
total hip replacement - short femoral stemDevice
total hip replacement with short femoral stem
| Study group | Role | What they receive |
|---|---|---|
| hype standard | Active comparator | total hip replacement with standard femoral stem Receives: Device: total hip replacement - standard femoral stem |
| hype mini | Experimental | total hip replacement with short uncemented femoral stem Receives: Device: total hip replacement - short femoral stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
stem subsidence
stem subsidence will be measured using the EBRA (Ein-Bild-Rontgen-analyse) software on postoperative antero-posterior radiographs (5 xrays from day one to year 2)
Measured: 2 years postop
Secondary outcomes (1)
Intraoperative surgeon satisfaction
measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start9 Mar 2018
- Primary completion9 Mar 2022 (estimated)
- Study completion9 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized 1/1 comparison
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr David BIAU, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
- Investigators
- David BIAU, MD, Principal investigator, Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500926
- Sponsor's protocol ID
- 2017-A03215-48
- Acronym
- hype
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
- ClinicalTrials.gov ID
- NCT03500926
- Acronym / sponsor ID
- hype / 2017-A03215-48
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et OrthopédiqueUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 9 Mar 2022 (estimated)
- Study completion
- 9 Mar 2025 (estimated)
- First posted
- 18 Apr 2018 (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 randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
Detailed description
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized 1/1 comparison
| Arm | Type | Receives |
|---|---|---|
| hype standard | Active comparator | Device: total hip replacement - standard femoral stemtotal hip replacement with standard femoral stem |
| hype mini | Experimental | Device: total hip replacement - short femoral stemtotal hip replacement with short uncemented femoral stem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hip osteoarthritis requiring a total hip replacement
- >18 years old
- agrees to participate
Key exclusion criteria (4 listed)
- total hip replacement not indicated
- general anesthesia contraindicated
- previous surgery on the ipsilateral femur
- follow-up not possible
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 replacement - standard femoral stemtotal hip replacement with standard femoral stem | Device | hype standard |
| total hip replacement - short femoral stemtotal hip replacement with short femoral stem | Device | hype mini |
Primary outcome
stem subsidence
Time frame: 2 years postop
stem subsidence will be measured using the EBRA (Ein-Bild-Rontgen-analyse) software on postoperative antero-posterior radiographs (5 xrays from day one to year 2)
1 secondary outcome
Intraoperative surgeon satisfaction
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
David BIAU, MD principal investigator
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total hip replacement - standard femoral stem and total hip replacement - short femoral stem in people with Osteoarthritis, Hip, run by Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique 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 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: status not confirmed, as of the sponsor's last update on 18 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David BIAU, MD (+33158413037, secretatiat.biau.cch@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stem subsidence (time frame: 2 years postop). 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 Apr 2018.