Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures
NCT ID: NCT04306198
Last Updated: 2020-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-03-31
2021-11-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lag Screw
Device: Trochanteric Fixation Nail (TFN) whit lag screw Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants
Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with lag screw as proximal fixation
Helical Blade
Device: Trochanteric Fixation Nail (TFN) whit helical blade Surgical stabilization of intertrochanteric hip fractures using two different proximal fixation implants
Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with helical blade as proximal fixation
Interventions
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Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with lag screw as proximal fixation
Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with helical blade as proximal fixation
Eligibility Criteria
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Inclusion Criteria
* Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)
Exclusion Criteria
* A fracture due to malignancy
* Peri implant fractures
* Inability to walk before the fracture
* An inability to comply with rehabilitation
* Non-ambulatory pre-fracture
65 Years
ALL
No
Sponsors
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Instituto Traumatologico Dr. Teodoro Gebauer Weisser
OTHER
Responsible Party
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Tomas Amenabar MD
Tomas Amenabar Vial , Head of hip and pelvis department.
Central Contacts
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References
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Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
Sommers MB, Roth C, Hall H, Kam BC, Ehmke LW, Krieg JC, Madey SM, Bottlang M. A laboratory model to evaluate cutout resistance of implants for pertrochanteric fracture fixation. J Orthop Trauma. 2004 Jul;18(6):361-8. doi: 10.1097/00005131-200407000-00006.
Al-Munajjed AA, Hammer J, Mayr E, Nerlich M, Lenich A. Biomechanical characterisation of osteosyntheses for proximal femur fractures: helical blade versus screw. Stud Health Technol Inform. 2008;133:1-10.
Ibrahim I, Appleton PT, Wixted JJ, DeAngelis JP, Rodriguez EK. Implant cut-out following cephalomedullary nailing of intertrochanteric femur fractures: Are helical blades to blame? Injury. 2019 Apr;50(4):926-930. doi: 10.1016/j.injury.2019.02.015. Epub 2019 Feb 20.
Other Identifiers
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1937
Identifier Type: -
Identifier Source: org_study_id
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