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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures: Are There Differences in the Failure Rate? A Prospective, Randomized Study

Conditions
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Hip Fractures

Intervention / Treatment
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* Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.
* Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low Energy Mechanism Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018) Exclusion Criteria: Medical contraindication to surgery A fracture due to malignancy Peri implant fractures Inability to walk before the fracture An inability to comply with rehabilitation Non-ambulatory pre-fracture

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lag Screw<br>Device: Trochanteric Fixation Nail (TFN) whit lag screw Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants | Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.<br>* Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with lag screw as proximal fixation<br>|
| Active Comparator: Helical Blade<br>Device: Trochanteric Fixation Nail (TFN) whit helical blade Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants | Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.<br>* Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with helical blade as proximal fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Failure | Rate of cut out , cut through, varus collapse | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Rate of Infection and Non Union. | 3 weeks, 3 months , 6 months | 
| Parker Mobility score | Score , Minimum value 0 , maximum value 9 , higher scores mean a better outcome. | 3 months , 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip fractures, Intertrochanteric fractures, Helical blade, Cut-out