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

NCT04408053 | Unknown Phase 3 DMC

• 1 other identifier: APHP180585
• Study Type: interventional
• Target: 812
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of a contralateral fracture of the proximal femur

  at 3 years after randomization

Secondary Outcomes (19)

• 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

  at 3 months after randomization

• Patient's autonomy

  at 1 year after randomization

• Patient's autonomy

  at 2 years after randomization

Study Arms (2)

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

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

No fixation

NO INTERVENTION

Interventions

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

Preventive fixation of the contralateral femoral neck

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• women and men
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

David Biau

CONTACT

+331 58 41 30 37; david.biau@aphp.fr

Matthieu RESCHE-RIGON, Pr

CONTACT

0142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2025
• Last Updated: May 29, 2020

Record last verified: 2020-05