Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures
- Conditions
- Hip Fractures
- Interventions
- Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.Device: Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.
- Registration Number
- NCT04306198
- Lead Sponsor
- Instituto Traumatologico Dr. Teodoro Gebauer Weisser
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Low Energy Mechanism
- Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Helical Blade Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation. Device: Trochanteric Fixation Nail (TFN) whit helical blade Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants Lag Screw Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation. Device: Trochanteric Fixation Nail (TFN) whit lag screw Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants
- Primary Outcome Measures
Name Time Method Implant Failure 6 months Rate of cut out , cut through, varus collapse
- Secondary Outcome Measures
Name Time Method Complications 3 weeks, 3 months , 6 months Rate of Infection and Non Union.
Parker Mobility score 3 months , 6 months Score , Minimum value 0 , maximum value 9 , higher scores mean a better outcome.