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

NCT ID: NCT04408053

Last Updated: 2020-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 812 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2025-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients

No fixation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

David Biau

Role: CONTACT

Phone: +331 58 41 30 37

Email: david.biau@aphp.fr

Matthieu RESCHE-RIGON, Pr

Role: CONTACT

Phone: 0142499742

Email: matthieu.resche-rigon@univ-paris-diderot.fr

Other Identifiers

APHP180585

Identifier Type: -

Identifier Source: org_study_id