Femoral Neck FracturesNCT04773145
Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years
An observational study of Femoral Neck Fractures, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems. The hydroxyapatite has a local effect which can improve cortical index. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Hemiarthroplasty with hydroaxyapatite coated stem
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2021to 24 Mar 2021
- 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 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All patients over 80 with femoral neck fracture
Who may be able to join
- 80 years
- 1 year follow-up
- femoral neck fracture
Who cannot join
- bad-realized radiographs
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Hôpital Central
Nancy, Lorraine, 54000
Mathias Kirsch, 0782931465, mathias.kirsch@hotmail.fr
About this study
This study aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems.
The hydroxyapatite has a local effect which can improve cortical index.
- Conditions
- Femoral Neck Fractures
- Being tested
- Hemiarthroplasty with hydroaxyapatite coated stem
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemiarthroplasty with hydroaxyapatite coated stemProcedure or surgery
Hemiarthroplasty with non cemented femoral stem, using the hydroxyapatite-coated femoral stem Pharo
| Study group | Role | What they receive |
|---|---|---|
| Femoral neck fracture | Patients over 80 years when suffering of femoral neck fracture with at least one year follow-up. Receives: Procedure: Hemiarthroplasty with hydroaxyapatite coated stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engh and Massin score
Measure of the osseointegration
Measured: 1 month
Secondary outcomes (1)
CBR
Mesure of level of osteoporosis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start24 Feb 2021
- Primary completion24 Mar 2021 (estimated)
- Study completion24 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didier MAINARD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773145
- Sponsor's protocol ID
- 2020PI257
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 26 Feb 2021
- 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 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years
- ClinicalTrials.gov ID
- NCT04773145
- Acronym / sponsor ID
- 2020PI257
- Conditions
- Femoral Neck Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 24 Mar 2021 (estimated)
- Study completion
- 24 Mar 2021 (estimated)
- First posted
- 26 Feb 2021 (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 aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems.
The hydroxyapatite has a local effect which can improve cortical index.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral neck fracture | – | Procedure: Hemiarthroplasty with hydroaxyapatite coated stemPatients over 80 years when suffering of femoral neck fracture with at least one year follow-up. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All patients over 80 with femoral neck fracture
Key inclusion criteria (3 listed)
- 80 years
- 1 year follow-up
- femoral neck fracture
Key exclusion criteria (1 listed)
- bad-realized radiographs
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 |
|---|---|---|
| Hemiarthroplasty with hydroaxyapatite coated stemHemiarthroplasty with non cemented femoral stem, using the hydroxyapatite-coated femoral stem Pharo | Procedure or surgery | Femoral neck fracture |
Primary outcome
Engh and Massin score
Time frame: 1 month
Measure of the osseointegration
1 secondary outcome
CBR
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- 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.
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 Femoral Neck Fractures, run by Central Hospital, Nancy, France 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 1 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 26 Feb 2021. 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 Mathias Kirsch, Intern (0782931465, mathias.kirsch@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engh and Massin score (time frame: 1 month). 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 26 Feb 2021.