Back to resultsMini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture (PREFIX)
Primary Purpose
Femoral Neck Fractures
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)
Sponsored by
About this trial
This is an interventional prevention trial for Femoral Neck Fractures
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Preventive fixation of the contralateral femoral neck
No fixation
Arm Description
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
Outcomes
Primary Outcome Measures
Cumulative incidence of a contralateral fracture of the proximal femur
Secondary Outcome Measures
Mortality
Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason
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).
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).
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).
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).
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.
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.
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.
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.
Proportion of patients receiving an antiosteoporotic treatment
Number of falls since the last follow-up visit
Number of falls since the last follow-up visit
Number of falls since the last follow-up visit
Number of falls since the last follow-up visit
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).
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).
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).
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).
Full Information
NCT ID
NCT04408053
First Posted
May 26, 2020
Last Updated
May 28, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04408053
Brief Title
Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
Acronym
PREFIX
Official Title
Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
812 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preventive fixation of the contralateral femoral neck
Arm Type
Experimental
Arm Description
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
Arm Title
No fixation
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)
Intervention Description
6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients
Primary Outcome Measure Information:
Title
Cumulative incidence of a contralateral fracture of the proximal femur
Time Frame
at 3 years after randomization
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
within 3 years after randomization
Title
Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason
Time Frame
within 3 years after randomization
Title
Patient's autonomy
Description
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).
Time Frame
at 3 months after randomization
Title
Patient's autonomy
Description
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).
Time Frame
at 1 year after randomization
Title
Patient's autonomy
Description
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).
Time Frame
at 2 years after randomization
Title
Patient's autonomy
Description
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).
Time Frame
at 3 years after randomization
Title
Patient's function
Description
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.
Time Frame
at 3 months after randomization
Title
Patient's function
Description
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.
Time Frame
at 1 year after randomization
Title
Patient's function
Description
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.
Time Frame
at 2 years after randomization
Title
Patient's function
Description
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.
Time Frame
at 3 years after randomization
Title
Proportion of patients receiving an antiosteoporotic treatment
Time Frame
at 3 months after randomization
Title
Number of falls since the last follow-up visit
Time Frame
at 3 months after randomization
Title
Number of falls since the last follow-up visit
Time Frame
at 1 year after randomization
Title
Number of falls since the last follow-up visit
Time Frame
at 2 years after randomization
Title
Number of falls since the last follow-up visit
Time Frame
at 3 years after randomization
Title
Pain on the contralateral hip
Description
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).
Time Frame
at 3 months after randomization
Title
Pain on the contralateral hip
Description
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).
Time Frame
at 1 year after randomization
Title
Pain on the contralateral hip
Description
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).
Time Frame
at 2 years after randomization
Title
Pain on the contralateral hip
Description
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).
Time Frame
at 3 years after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Biau
Phone
+331 58 41 30 37
Email
david.biau@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu RESCHE-RIGON, Pr
Phone
0142499742
Ext
0142499742
Email
matthieu.resche-rigon@univ-paris-diderot.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
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