Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture

Not Applicable

Recruiting

• Conditions: Femoral Neck Fractures
• Interventions: Device: Femoral Neck System; Device: Multiple Cannulated Screw

• Registration Number: NCT04589598
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture.

Detailed Description

Clinical outcomes include reoperation, loss of fixation, and change of mobility.

Study Timeline

• Study Start: 2019-10-30
• Study First Submitted: 2020-09-27
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24
• Primary Completion: 2023-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

• 18 years and older
• non-displaced femoral neck fracture
• community ambulator

Exclusion Criteria

• younger than 18 years
• displaced femoral neck fracture
• intertrochanteric fracture
• subtrochanteric fracture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FNS	Femoral Neck System	those who are treated with femoral neck system (FNS)
MCS	Multiple Cannulated Screw	those who are treated with multiple cannulated screw (MCS)

Primary Outcome Measures

Name	Time	Method
Reoperation	24 months	rate of reoperation

Secondary Outcome Measures

Name	Time	Method
loss of fixation	24 months	Rate of loss of fixation

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of