Status:
UNKNOWN
Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Femoral Neck Fractures
Eligibility:
All Genders
80+ years
Phase:
PHASE3
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
812 Patients enrolled
Trial Details
Trial ID
NCT04408053
Start Date
September 1 2020
End Date
September 1 2025
Last Update
May 29 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.