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

Phase 3

Not yet recruiting

• Conditions: Femoral Neck Fractures
• Interventions: Device: Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)

• Registration Number: NCT04408053
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29
• Study Start: 2020-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 812

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preventive fixation of the contralateral femoral neck	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

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of a contralateral fracture of the proximal femur	at 3 years after randomization

Secondary Outcome Measures

Name	Time	Method
Patient's function	at 3 years after randomization	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.
Mortality	within 3 years after randomization
Proportion of patients receiving an antiosteoporotic treatment	at 3 months after randomization
Pain on the contralateral hip	at 3 years after randomization	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).
Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason	within 3 years after randomization
Patient's autonomy	at 3 years after randomization	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).
Number of falls since the last follow-up visit	at 3 years after randomization