- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410338
Lateral Decubitus vs Traction in the Supine Position in Proximal Femoral Nailing. Is There a Huge Difference?
February 8, 2026 updated by: Ain Shams University
Proximal Femoral Nailing in Unstable Intertrochanteric Fractures: Lateral Decubitus Position Versus Supine Position on Traction Table.
This study is designed to compare two positions in the management of unstable intertrochanteric femur fractures.
It's to compare the traditional supine position using a traction table and lateral decubitus.
This study is designed to Compare between The accuracy of reduction In both methods, in addition,the radiological exposure and other secondary outcomes, like the blood loss, are compared.
Study Overview
Status
Completed
Conditions
Detailed Description
To compare the fluoroscopic exposure time, quality of radiographic reduction, intra operative blood loss, setup time and surgical time between the lateral decubitus position and the use of a traction table in supine position in fixation of unstable intertrochanteric femur fractures by proximal femoral nail.
Study Type
Interventional
Enrollment (Actual)
77
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
-
-
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Cairo, Egypt, 11566
- Ain shams university hospitals
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-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Skeletally mature patients
- Unstable intertrochanteric fracture ( AO/OTA type 31A2 & 31A3 )
Exclusion Criteria:
- Patients unfit for surgery
- Revision cases
- Patients with multiple or pathological, neglected or open fractures.
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Lateral postion during proximal femoral nailing for unstable intertrochnateric femur fractures
Proximal femoral nailing in lateral decubitus position
|
different positions of the patient during the surgery
|
|
Active Comparator: Supine postion using traction table in proximal femoral nailing intertrochanteric femur fractures
Proximal femoral nailing in supine position using traction table
|
different positions for the proximal femoral nailing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of radiographic reduction
Time Frame: immediate postoperative
|
Optimum Tip-to-apex distance (TAD) is 25mm or less.
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immediate postoperative
|
|
Fluoroscopic exposure time
Time Frame: intraoperative
|
The fluoroscopic exposure time is defined as: The total duration of fluoroscopy use in minutes during the set up and the surgical procedure.
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Setup time
Time Frame: Intraoperative
|
The period between the moment of transfer of the patient from the anesthesia team to the surgical team till the time of incision.
This period includes placement of the patient on the surgical table or the traction table, preparation, and draping.
The reduction and use of fluoroscopy during the reduction will be included within this time frame.
|
Intraoperative
|
|
Surgical time
Time Frame: Intraoperative
|
The time between the skin incision and the closure of the wound.
|
Intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amr Ahmed Abd Elrahman Hasan, Professor of Orthopedics, Department of Orthoepdics - Faculty of Medicine - Ain Shams University
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)
June 30, 2024
Primary Completion (Actual)
July 30, 2025
Study Completion (Actual)
July 30, 2025
Study Registration Dates
First Submitted
February 8, 2026
First Submitted That Met QC Criteria
February 8, 2026
First Posted (Actual)
February 13, 2026
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 8, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MS734/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Not decided yet
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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