Clinical trial NCT04408053: Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
Official title: Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Femoral Neck Fractures
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 812
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Cumulative incidence of a contralateral fracture of the proximal femur
timeFrame: at 3 years after randomization
Secondary outcomes:
measure: Mortality
timeFrame: within 3 years after randomization
measure: Proportion of patients requiring surgery on the contralateral proximal femur regardless the reason
timeFrame: within 3 years after randomization
measure: Patient's autonomy
timeFrame: at 3 months after randomization
measure: Patient's autonomy
timeFrame: at 1 year after randomization
measure: Patient's autonomy
timeFrame: at 2 years after randomization
measure: Patient's autonomy
timeFrame: at 3 years after randomization
measure: Patient's function
timeFrame: at 3 months after randomization
measure: Patient's function
timeFrame: at 1 year after randomization
measure: Patient's function
timeFrame: at 2 years after randomization
measure: Patient's function
timeFrame: at 3 years after randomization
measure: Proportion of patients receiving an antiosteoporotic treatment
timeFrame: at 3 months after randomization
measure: Number of falls since the last follow-up visit
timeFrame: at 3 months after randomization
measure: Number of falls since the last follow-up visit
timeFrame: at 1 year after randomization
measure: Number of falls since the last follow-up visit
timeFrame: at 2 years after randomization
measure: Number of falls since the last follow-up visit
timeFrame: at 3 years after randomization
measure: Pain on the contralateral hip
timeFrame: at 3 months after randomization
measure: Pain on the contralateral hip
timeFrame: at 1 year after randomization
measure: Pain on the contralateral hip
timeFrame: at 2 years after randomization
measure: Pain on the contralateral hip
timeFrame: at 3 years after randomization
Other outcomes:
Locations:
Study officials:
References: