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Active Not Recruiting NCT07896031

BDSF Vs DHS With Anterotational Screw in Vertical FNF

Conditions: Evaluation of BDSF in FNF

Sex: All
Ages: 16 Years – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: Ain Shams University

Location: Ain Shams University Cairo Abassia

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.

Eligibility Criteria

Inclusion Criteria: * Pauwels type III vertical femoral neck fracture * Isolated femoral neck fracture * Age between 18 and 50 years, inclusive Exclusion Criteria: * Pauwels type I or type II femoral neck fracture * Associated pelvic ring or acetabular fracture requiring intervention * Associated lower-extremity fracture requiring intervention * Femoral neck fracture more than 14 days old * Pathological fracture * Age younger than 18 years or older than 50 years

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07896031). StuddyBuddy aggregates publicly available trial information.