Femoral Neck Locking Plate Vs Multiple Cannulated Cancellous Screws in Treatment of Femoral Neck Fractures in Young Adults: Randomized Controlled Clinical Trial Study

Fracture neck femur are common injuries, especially seen in the elderly in the emergency setting. It is also seen in young patients with high-energy trauma. Immediate diagnosis and management are required to prevent threatening joint complications. Fracture neck femur in young adults is unsolved problem. The preservation of the native hip anatomy and biomechanics is essential in active young adults. Because of the vulnerable blood supply to the femoral part of the hip joint following these fractures, there is a high risk of developing avascular necrosis (AVN) and non-union. Any sort of surgical fixation should aim at preservation the blood supply while securing enough mechanical stability until the fracture unites. Open reduction is indicated in fractures which cannot be anatomically reduced by gentle manipulation. This should be carried out without any delay since this potentially can reduce the incidence of AVN. Treatment of fracture neck femur still controversial. There are several methods for treatment of fracture neck femur as multipe cannulated cancellous screws, locking plate, dynamic hip screw (DHS) with anti-rotational screw, and arthroplasty. There is no internal fixation method superior to another. In this study, we will compare the clinical and radiographic results of femoral neck locking plate vs multiple cannulated cancellous screw in treating femoral neck fractures in young adults.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Device: femoral neck locking plate; Device: multiple cannulated cancellous screws

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Islam M Ahmed, resident; Phone Number: 01094375737; Email: eslammohamed@med.sohag.edu.eg
• Study Contact Backup: Name: Abdelrahman H Khalifa, professor; Phone Number: 01003701283

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag university Hospital
    • Contact: Magdy M Amin, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients (20-55) years
• having unilateral traumatic femoral neck fracture
• idependent walker before trauma without any aids

Exclusion Criteria:

• open fracture
• pathological fracture
• preexisting deformity
• other pelvic or ipsilateral femoral injuries
• renal impairment or were on high dose steroids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A; grup A with femoral neck fracture will be fixed by femoral neck locking plate	Device: femoral neck locking plate; femoral neck fractures fixation by femoral neck locking plate
Other: B; grup B with femoral neck fracture will be fixed by Multiple cannulated cancellous screws	Device: multiple cannulated cancellous screws; femoral neck fractures fixation by multiple cannulated cancellous screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of pain on the Harris Hip Score (HHS) 6 months post operative	the Harris Hip Score (HHS) is a scale used for evaluating patients following hip fractures. possible scores range for improvement of pain from 44 (no pain) to 0 (totally disabled cripped pain).	6 months
Clinical evaluation of gait limping on the Harris Hip Score (HHS) 6 months post operative	the Harris Hip Score (HHS) is a scale used for evaluating patients following hip fractures. possible scores for limping gait range from 11 (none) to 0 (unable to walk).	6 months

Collaborators and Investigators

• Sponsor: Eslam Mohamed AHmed

Publications and helpful links

General Publications

• Haidukewych GJ, Rothwell WS, Jacofsky DJ, Torchia ME, Berry DJ. Operative treatment of femoral neck fractures in patients between the ages of fifteen and fifty years. J Bone Joint Surg Am. 2004 Aug;86(8):1711-6. doi: 10.2106/00004623-200408000-00015.
• Panula J, Pihlajamaki H, Mattila VM, Jaatinen P, Vahlberg T, Aarnio P, Kivela SL. Mortality and cause of death in hip fracture patients aged 65 or older: a population-based study. BMC Musculoskelet Disord. 2011 May 20;12:105. doi: 10.1186/1471-2474-12-105.
• Crist BD, Eastman J, Lee MA, Ferguson TA, Finkemeier CG. Femoral Neck Fractures in Young Patients. Instr Course Lect. 2018 Feb 15;67:37-49.
• Ly TV, Swiontkowski MF. Treatment of femoral neck fractures in young adults. J Bone Joint Surg Am. 2008 Oct;90(10):2254-66. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: Soh-Med-23-11-02MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No