Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures

Not Applicable

• Conditions: Hip Fractures
• Interventions: Device: Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.; Device: Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.

• Registration Number: NCT04441723
• Lead Sponsor: Instituto Traumatologico Dr. Teodoro Gebauer Weisser

Brief Summary

The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail.

The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture.

Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.

Detailed Description

Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly . They produce great disability and complications in our patients and they are recognized worldwide as a major public health problem.

The treatment that presents the best results is surgical treatment, since it reduces the mortality of the patients and allows early loading . Thus, avoids secondary complications to the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.

Currently, the treatment that has shown the best clinical and biomechanical results is osteosynthesis with a cephalomedullary nail, which despite having good results is not free from complications such as implant failure, loss of femoral offset.

Changes are constantly made in the design and surgical techniques of these implants in order to decrease the rate of complications.

This study will particularly assess whether there is any difference in the complication rate between dynamic versus static lag screw modes.

Biomechanical studies that compare these two lag screw modes show that axial and lateral stiffness of the femur-nail construction is greater in static mode than in dynamic modes and the torsional stiffness is greater in dynamic mode than in static modes.

There are no studies comparing the clinical results of these two variants.

Study Timeline

• Study Start: 2020-01-11
• Status Verified: 2020-06
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-24
• Primary Completion: 2021-02-01
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• A fracture due to malignancy
• Previous contralateral fracture
• Inability to walk before the fracture
• An inability to comply with rehabilitation
• Follow-up of less than 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lag screw with static mode	Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.	Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes
lag screw with dynamic mode	Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.	Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes

Primary Outcome Measures

Name	Time	Method
Implant failure	6 months	Rate of cut out , cut through.

Secondary Outcome Measures

Name	Time	Method
Complications	3 weeks, 3 months , 6 months	Rate of Infection and Non Union.
Offset	6 months	Changes in femoral offset

Trial Locations

Locations (1)

Instituto Traumatologico; 🇨🇱 Santiago, Chile