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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04441723

Enrollment

150

Registered

2020-06-22

Start date

2020-01-11

Completion date

2021-07-30

Last updated

2020-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Keywords

Hip fractures, Intertrochanteric fractures, Cephalomedullary Nails, Cut-out, Cut through

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.

Interventions

DEVICEOsteosynthesis 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

DEVICEOsteosynthesis 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Implant failure	6 months	Rate of cut out , cut through.

Secondary

Measure	Time frame	Description
Complications	3 weeks, 3 months , 6 months	Rate of Infection and Non Union.
Offset	6 months	Changes in femoral offset

Countries

Chile

Contacts

Primary ContactPablo Suarez, MD

pablosuarez088@gmail.com+56961572181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026