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ACTIVE NOT RECRUITING
NCT07896031
PHASE2

BDSF Vs DHS With Anterotational Screw in Vertical FNF

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

Pauwels type III femoral neck fractures in young adults commonly result from high-energy trauma and are characterized by a vertical fracture orientation with substantial shear and rotational forces. These fractures are associated with an increased risk of mechanical instability, nonunion, varus collapse, fixation failure, and osteonecrosis of the femoral head. Successful treatment therefore requires anatomical reduction and stable internal fixation capable of resisting both vertical shear and rotational forces. A Sliding Hip Screw combined with an antirotation screw provides controlled fracture compression and additional rotational stability. Biplane Double Support Screw Fixation is an alternative technique in which cannulated screws are inserted in two planes to provide double cortical support. The distal screw entry points and calcar-supported configuration are intended to distribute axial loading toward the femoral diaphysis, improve mechanical stability, facilitate fracture impaction, and reduce the risk of varus collapse. This prospective randomized controlled study will compare Biplane Double Support Screw Fixation with Sliding Hip Screw fixation combined with an antirotation screw in young adults with Pauwels type III femoral neck fractures. Participants will be randomly allocated in a 1:1 ratio to receive one of the two fixation techniques. The study will compare fracture healing, functional recovery, radiological outcomes, and postoperative complications between the two groups. Particular attention will be given to nonunion, osteonecrosis of the femoral head, varus collapse, implant failure, and the need for additional surgery. The study hypothesis is that Biplane Double Support Screw Fixation may provide stable fixation with clinical and radiological outcomes comparable or superior to those achieved using a Sliding Hip Screw with an antirotation screw.

Official title: Biplane Double Support Screw Fixation Versus Sliding Hip Screw With Antirotation Screw in Management of Pauwels Type III Neck of Femur Fractures in Young Adults: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

16 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-09-01

Completion Date

2027-05-01

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

PROCEDURE

Dynamic Hip Screw with Anterotation Screw Fixation

nternal fixation of the femoral neck fracture using a dynamic hip screw with a side plate, supplemented with a parallel antirotation screw to improve rotational stability of the femoral head and neck fragment.

PROCEDURE

Biplane Double-Supported Screw Fixation

Internal fixation of the femoral neck fracture using three cannulated screws inserted according to the biplane double-supported screw fixation technique. The screws will be positioned in two oblique planes to obtain cortical support at the femoral neck and improve the biomechanical stability of the fracture fixation.

Locations (1)

Ain Shams University

Cairo, Abassia, Egypt