Open Reduction in Femoral Neck Fractures (OR FNFS)

March 10, 2025 updated by: Samer youssef mansour meglaa

Outcomes of Open Reduction and Internal Fixation of Femoral Neck Fractures Using Dynamic Hip Screw Vs Cannulated Screws and Medial Buttress Plate

Outcomes of open reduction and internal fixation of femoral neck fractures using dynamic hip screw versus cannulated screws combined with medial buttress plate.

Study Overview

Detailed Description

-Femoral neck fractures (FNFs) in patients under the age of 50 years account for less than 5% of all hip fractures and are typically the result of a high-energy event.

FNFs in young patients, particularly displaced fractures, are challenging to treat. Internal fixation remains the consensus, and the quality of the reduction is more important than the time to surgery.

Femoral head necrosis and fracture nonunion have always been the two major complications of femoral neck fracture treatment, which greatly increases the difficulty of treatment and places a high burden on social and medical resources.

As previous studies have demonstrated, reoperation rate for a failure of internal fixation ranges from 10% to 48.8% and has remained largely unchanged over the past 30 years.

There are many options to treat femoral neck fracture. Previous studies reported that femoral neck fractures with following surgery are associated implant failure.

Currently, the most common types of fixation include cannulated screws, hip screw systems, proximal femur plates, and cephalomedullary nails. [7]

Arthroplasty may be an option for elderly patients, but is generally not feasible for young patients; young patients with FNF require a more durable and promising fixation. However, there is no consensus on the best fixation method for FNF in young patients.

CS has better biomedical properties such as anti-rotation and less invasive, which was widely used in non-displaced intracapsular fractures.

DHS could maintain the neck-shaft angle and anatomical reduction, which is helpful for fracture fixation.

A medial buttress plate can clamp the fracture apex, neutralize shearing forces, and transfer them into compressive forces into the plane of cannulated screws or other typical construct.

Thus far, there has been no optimal internal fixation method.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt
        • Assuit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients of both genders between the ages of 16 to 60 years old and had trauma caused femoral neck fracture.
  • patients of both genders with Garden's type three and four femoral neck fractures

Exclusion Criteria:

  • patients of both genders below the age of 16 and above 60 years old.
  • patients with pathological femoral neck fractures.
  • patients with autoimmune diseases like rheumatoid arthritis.
  • patients with neglected femoral neck fractures(more than 1 week).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open reduction of femoral neck fractures in healthy adults
Open reduction of femoral neck fractures in healthy adults between 16 years and 60 years old using cannulated screws and medial buttress plate through watson jones or smith peterson approach
Open reduction of femoral neck using watson jones or smith peterson approach fractures then fixation of fractures by dynamic hip screws
Open reduction of femoral neck fractures then fixation of fractures by cannulated screws and medial buttress plate
Experimental: Open reduction of femoral neck fractures
Open reduction and internal fixation of femoral neck fracture in healthy adults between 16 years and 60 years old using dynamic hip screw through watson jones or smith peterson approach
Open reduction of femoral neck using watson jones or smith peterson approach fractures then fixation of fractures by dynamic hip screws
Open reduction of femoral neck fractures then fixation of fractures by cannulated screws and medial buttress plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: 3 years

Using harris hip score evaluate to evaluate post operative:

  1. pain
  2. amount and type of support
  3. limp
  4. distance walked
  5. shoes and socks
  6. sitting
  7. climbing stairs
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Open reduction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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