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

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 Overview

• Status: Not yet recruiting
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Device: Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)

• Study Type: Interventional
• Enrollment (Anticipated): 812
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Matthieu RESCHE-RIGON, Pr; Phone Number: 0142499742 0142499742; Email: matthieu.resche-rigon@univ-paris-diderot.fr
• Study Contact Backup: Name: David Biau; Phone Number: +331 58 41 30 37; Email: david.biau@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: APHP180585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No