Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study will be to compare the failure and complications rates of and orthopedic implant (Cephalomedullary Nail) fixed with two different options actually available: lag screw or helical blade.

The study population will be patient who have been diagnosed with an intertrochanteric hip fracture.

Hypothesis: Our hypothesis is that the helical blade will have a higher failure rate compared to the lag screw

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04306198
Study type	Interventional
Source	Instituto Traumatologico Dr. Teodoro Gebauer Weisser
Contact	Tomas Amenabar, MD
Phone	+56991594716
Email	tomasamenabar@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	March 2020
Completion date	November 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms