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

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

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

Study Overview

• Status: Unknown
• Conditions: Hip Fractures
• Intervention / Treatment: 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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomas Amenabar, MD; Phone Number: +56991594716; Email: tomasamenabar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lag Screw; 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.; Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with lag screw as proximal fixation
ACTIVE_COMPARATOR: Helical Blade; 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.; Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with helical blade as proximal fixation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Traumatologico Dr. Teodoro Gebauer Weisser

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Hip fractures; Intertrochanteric fractures; Cut-out; Helical blade
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 1937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes