NCT04441723

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Instituto Traumatologico Dr. Teodoro Gebauer Weisser · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Fractures

Interventions

Type	Name	Description
DEVICE	Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.	Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation
DEVICE	Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.	Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation

Timeline

• Start date: 2020-01-11
• Primary completion: 2021-02-01
• Completion: 2021-07-30
• First posted: 2020-06-22
• Last updated: 2020-06-24

Locations

1 site across 1 country: Chile

Regulatory

• FDA-regulated device study