Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hip Fractures
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

Description

Hip fractures in the elderly are recognized worldwide as a major public health problem, its incidence is increasing and it is expected to have 6,26 million cases per year worldwide by 2050. Surgical treatment is recognized as the best option in these patients because it allows early rehabilitation a...

Hip fractures in the elderly are recognized worldwide as a major public health problem, its incidence is increasing and it is expected to have 6,26 million cases per year worldwide by 2050. Surgical treatment is recognized as the best option in these patients because it allows early rehabilitation and decreases mortality and complications. Currently, the fixation with a cephalomedullary nail is the most commonly used treatment, since it has some mechanical advantages compared to other fixation methods and achieves adequate stability allowing early weight bearing and rehabilitation with low failure rates. Changes in the design of these implants have tried to reduce the failure rate. The main change has been the introduction of the helical blade for cephalic fixation, instead of a lag screw. The concept behind this modification is that the blade would have greater fixation to the bone and less risk of cut out, because it is supposed to compact the bone around the helical blade instead of removing it. In spite of some biomechanical studies in cadaveric or artificial models validating this biomechanical advantage, clinical series have shown controversial results. Recently, retrospective clinical studies have shown similar results with the use of the helical blade, and even some studies have shown a higher failure rate compared to the sliding screw. Currently there is no prospective evidence regarding the failure rate of these two fixation methods. Our objective is to contribute with solid evidence to solve this answer. That is why we have designed a prospective randomized study with strict inclusion criteria, follow up and radiographic measurements.

Tracking Information

NCT #
NCT04306198
Collaborators
Not Provided
Investigators
Not Provided