Femoral Neck FracturesPhase 3PREFIXNCT04408053
Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
A Phase 3 study testing Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws) in people with Femoral Neck Fractures, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
In France, the annual incidence of hip fracture is about 80 000 with more than 75% of these fractures occurring in patients aged 80 years old or more. About 10% percent of patients presenting with a hip fracture will sustain a contralateral hip fracture, most within 3 years. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2025
- Phase
- Phase 3
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- women and men
- 80 years or older
- operated on for a femoral neck fracture
- presenting one, or more, added clinical risk factor of hip fracture*
- a fragility fracture in the past five years
- a history of fall in the past 12 months (not considering the fall that led to the present fracture)
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- a very high risk of falling: use of psychoactive medication or impaired vision or impaired neuromuscular function
- BMI lower than 20kg/m2
- giving her/his consent.
- affiliated to the social security
Who cannot join
- history of a contralateral proximal femoral fracture
- history of a surgical operation of the contralateral proximal femur
- ongoing infection (bone or soft-tissue) on the contralateral hip
- contraindication of MIPF of the contralateral hip
- non ambulatory patients
- patients already included in the study
Show all 13Show fewer
- patients with contraindication to the medical devices under evaluation
- patients not suitable for a surgical procedure (including not suitable for an anaesthetic)
- patients with a benign or malignant bone lesion of the contralateral femur
- patients included in another clinical research which could directly have an effect on the femoral neck bone strength
- patients presenting with a grade 4 Kellgren-Lawrence osteoarthritis of the contralateral hip and reporting significant clinical symptoms
- patients with an life expectancy of less than 3 months
- patients with a legal representative (tutorship or guardianship) and insane patients will be excluded
Trial locations and contacts
No sites are listed yet.
Matthieu RESCHE-RIGON, Pr contact
About this study
In France, the annual incidence of hip fracture is about 80 000 with more than 75% of these fractures occurring in patients aged 80 years old or more. About 10% percent of patients presenting with a hip fracture will sustain a contralateral hip fracture, most within 3 years. The consequences of a hip fracture are dramatic: 20% of patients die in the first year and less than half those who survive regain their previous level of function. Hip fractures are invariably associated with chronic pain, reduced mobility, disability, and an increasing degree of dependence. The efficacy of pharmacological treatments to prevent a contralateral hip fracture is marginal and postponed and compliance is known to be poor.
Osteoporosis is associated with cortical thinning and trabecular bone loss. Therefore, the mini-invasive preventive fixation (MIPF) of the contralateral femoral neck is appealing. The effect is immediate and compliance is certain. Morbidity is minimal because it is performed during the same operation as the fixation of the femoral neck fracture.
The main objective of this study is to determine whether the mini-invasive preventive fixation (MIPF) of the contralateral femoral neck in patients having a femoral neck fracture is superior to no fixation regarding the occurrence of a contralateral hip fracture within 3 years.
- Conditions
- Femoral Neck Fractures
- Being tested
- Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)
- 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.
Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)Device
6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients
| Study group | Role | What they receive |
|---|---|---|
| Preventive fixation of the contralateral femoral neck | Experimental | Mini-invasive preventive fixation of the contralateral femoral neck : 6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients Receives: Device: Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws) |
| No fixation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of a contralateral fracture of the proximal femur
Measured: at 3 years after randomization
Secondary outcomes (19)
Mortality
Measured: within 3 years after randomization
Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason
Measured: within 3 years after randomization
Patient's autonomy
Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).
Measured: at 3 months after randomization
Patient's autonomy
Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).
Measured: at 1 year after randomization
Patient's autonomy
Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).
Measured: at 2 years after randomization
Patient's autonomy
Patient's autonomy will be assessed using the AGGIR scale. The AGGIR scale has 10 physical and mental variables and seven variables relating to domestic and social activities; the former are discriminative and the latter illustrative variables. The rating depends on the person doing the activity on her/his own; however, material and technical aids are allowed (glasses, wheelchair, etc). Each variable can take one of three modalities: A (perform alone), C (cannot perform alone), and B (can perform alone but on conditions).
Measured: at 3 years after randomization
Patient's function
Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as "no difficulty", with an aid"; "with the help from another person"; "not at all". Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.
Measured: at 3 months after randomization
Patient's function
Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as "no difficulty", with an aid"; "with the help from another person"; "not at all". Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.
Measured: at 1 year after randomization
Patient's function
Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as "no difficulty", with an aid"; "with the help from another person"; "not at all". Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.
Measured: at 2 years after randomization
Patient's function
Patient's function will be assessed using the Parker score. The Parker scale assessment of mobility rates three questions: able to get about the house; able to get out of the house; able to go shopping. Each question may be answered as "no difficulty", with an aid"; "with the help from another person"; "not at all". Answer are weighted from 3 (no difficulty) to 0 (not at all). The maximum mobility score is 9; the lowest is 0.
Measured: at 3 years after randomization
Proportion of patients receiving an antiosteoporotic treatment
Measured: at 3 months after randomization
Number of falls since the last follow-up visit
Measured: at 3 months after randomization
Number of falls since the last follow-up visit
Measured: at 1 year after randomization
Number of falls since the last follow-up visit
Measured: at 2 years after randomization
Number of falls since the last follow-up visit
Measured: at 3 years after randomization
Pain on the contralateral hip
Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).
Measured: at 3 months after randomization
Pain on the contralateral hip
Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).
Measured: at 1 year after randomization
Pain on the contralateral hip
Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).
Measured: at 2 years after randomization
Pain on the contralateral hip
Patients will be asked to rate the level of pain of the contralateral hip using a visual analogic scale,, which goes from 0 (no pain) to 10 (maximum pain imaginable).
Measured: at 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2025 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408053
- Sponsor's protocol ID
- APHP180585
- Acronym
- PREFIX
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT04408053
- Acronym / sponsor ID
- PREFIX / APHP180585
- Conditions
- Femoral Neck Fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 812 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 29 May 2020 (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.
In France, the annual incidence of hip fracture is about 80 000 with more than 75% of these fractures occurring in patients aged 80 years old or more. About 10% percent of patients presenting with a hip fracture will sustain a contralateral hip fracture, most within 3 years. The consequences of a hip fracture are dramatic: 20% of patients die in the first year and less than half those who survive regain their previous level of function. Hip fractures are invariably associated with chronic pain, reduced mobility, disability, and an increasing degree of dependence. The efficacy of pharmacological treatments to prevent a contralateral hip fracture is marginal and postponed and compliance is known to be poor.
Osteoporosis is associated with cortical thinning and trabecular bone loss. Therefore, the mini-invasive preventive fixation (MIPF) of the contralateral femoral neck is appealing. The effect is immediate and compliance is certain. Morbidity is minimal because it is performed during the same operation as the fixation of the femoral neck fracture.
The main objective of this study is to determine whether the mini-invasive preventive fixation (MIPF) of the contralateral femoral neck in patients having a femoral neck fracture is superior to no fixation regarding the occurrence of a contralateral hip fracture within 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive fixation of the contralateral femoral neck | Experimental | Device: Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)Mini-invasive preventive fixation of the contralateral femoral neck : 6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients |
| No fixation | No intervention | – |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- women and men
- 80 years or older
- operated on for a femoral neck fracture
- presenting one, or more, added clinical risk factor of hip fracture*
- a fragility fracture in the past five years
Key exclusion criteria (13 listed)
- history of a contralateral proximal femoral fracture
- history of a surgical operation of the contralateral proximal femur
- ongoing infection (bone or soft-tissue) on the contralateral hip
- contraindication of MIPF of the contralateral hip
- non ambulatory patients
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 |
|---|---|---|
| Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients | Device | Preventive fixation of the contralateral femoral neck |
Primary outcome
Cumulative incidence of a contralateral fracture of the proximal femur
Time frame: at 3 years after randomization
19 secondary outcomes
Mortality
Time frame: within 3 years after randomization
Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason
Time frame: within 3 years after randomization
Patient's autonomy
Time frame: at 3 months after randomization
Patient's autonomy
Time frame: at 1 year after randomization
Patient's autonomy
Time frame: at 2 years after randomization
Patient's autonomy
Time frame: at 3 years after randomization
Patient's function
Time frame: at 3 months after randomization
Patient's function
Time frame: at 1 year after randomization
Patient's function
Time frame: at 2 years after randomization
Patient's function
Time frame: at 3 years after randomization
Proportion of patients receiving an antiosteoporotic treatment
Time frame: at 3 months after randomization
Number of falls since the last follow-up visit
Time frame: at 3 months after randomization
Number of falls since the last follow-up visit
Time frame: at 1 year after randomization
Number of falls since the last follow-up visit
Time frame: at 2 years after randomization
Number of falls since the last follow-up visit
Time frame: at 3 years after randomization
Pain on the contralateral hip
Time frame: at 3 months after randomization
Pain on the contralateral hip
Time frame: at 1 year after randomization
Pain on the contralateral hip
Time frame: at 2 years after randomization
Pain on the contralateral hip
Time frame: at 3 years after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- 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.
Matthieu RESCHE-RIGON, Pr contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws) in people with Femoral Neck Fractures, run by Assistance Publique - Hôpitaux de Paris.
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 10 inclusion and 13 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 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+331 58 41 30 37, david.biau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of a contralateral fracture of the proximal femur (time frame: at 3 years after randomization). 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 29 May 2020.