Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture

Study Overview
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Brief Summary
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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.

Official Title
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Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Device: Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventive fixation of the contralateral femoral neck<br>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 | Device: Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)<br>* 6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients<br>|
| No Intervention: No fixation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of a contralateral fracture of the proximal femur |  | at 3 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | within 3 years after randomization | 
| Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason |  | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | at 3 years after randomization | 
| Proportion of patients receiving an antiosteoporotic treatment |  | at 3 months after randomization | 
| Number of falls since the last follow-up visit |  | at 3 months after randomization | 
| Number of falls since the last follow-up visit |  | at 1 year after randomization | 
| Number of falls since the last follow-up visit |  | at 2 years after randomization | 
| Number of falls since the last follow-up visit |  | 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). | 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). | 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). | 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). | at 3 years after randomization |