- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06872970
Open Reduction in Femoral Neck Fractures (OR FNFS)
Outcomes of Open Reduction and Internal Fixation of Femoral Neck Fractures Using Dynamic Hip Screw Vs Cannulated Screws and Medial Buttress Plate
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt
- Assuit University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
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:
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Open reduction
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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