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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441723
• Other study ID #: STVSDY
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: June 2020
• Source: Instituto Traumatologico Dr. Teodoro Gebauer Weisser
• Contact: Pablo Suarez, MD
• Phone: +56961572181
• Email: pablosuarez088[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 30, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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
• 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

Locations

Country	Name	City	State
Chile	Instituto Traumatologico	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Traumatologico Dr. Teodoro Gebauer Weisser

Country where clinical trial is conducted

Chile, 

References & Publications (3)

Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. Review. — View Citation

Kuzyk PR, Shah S, Zdero R, Olsen M, Waddell JP, Schemitsch EH. A biomechanical comparison of static versus dynamic lag screw modes for cephalomedullary nails used to fix unstable peritrochanteric fractures. J Trauma Acute Care Surg. 2012 Feb;72(2):E65-70. — View Citation

Mahomed N, Harrington I, Kellam J, Maistrelli G, Hearn T, Vroemen J. Biomechanical analysis of the Gamma nail and sliding hip screw. Clin Orthop Relat Res. 1994 Jul;(304):280-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant failure	Rate of cut out , cut through.	6 months
Secondary	Complications	Rate of Infection and Non Union.	3 weeks, 3 months , 6 months
Secondary	Offset	Changes in femoral offset	6 months