Unstable Intertrochanteric FractureNCT07410338
Lateral Decubitus vs Traction in the Supine Position in Proximal Femoral Nailing. Is There a Huge Difference?
A study testing lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fractures and Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction table in people with Unstable Intertrochanteric Fracture, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unstable Intertrochanteric Fracture
- What is being tested?
- lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fractures and Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction table
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature patients
- Unstable intertrochanteric fracture ( AO/OTA type 31A2 \& 31A3 )
Who cannot join
- Patients unfit for surgery
- Revision cases
- Patients with multiple or pathological, neglected or open fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Unstable Intertrochanteric Fracture
- Being tested
- lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fractures, Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction table
- Keywords
- Unstable intertrochanteric fracture, Proximal femoral nail, proximal femoral fractures, traction table, lateral decubitus
- Medical subject headings
- Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fracturesProcedure or surgery
different positions of the patient during the surgery
Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction tableProcedure or surgery
different positions for the proximal femoral nailing
| Study group | Role | What they receive |
|---|---|---|
| Lateral postion during proximal femoral nailing for unstable intertrochnateric femur fractures | Active comparator | Proximal femoral nailing in lateral decubitus position Receives: Procedure: lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fractures |
| Supine postion using traction table in proximal femoral nailing intertrochanteric femur fractures | Active comparator | Proximal femoral nailing in supine position using traction table Receives: Procedure: Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction table |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of radiographic reduction
Optimum Tip-to-apex distance (TAD) is 25mm or less.
- Normal femoral neck shaft angle between 125 and 145 degree.
- The Baumgartner reduction quality criteria : -
- Criterion one (alignment) :
- Anterior posterior view : normal or slight valgus neck shaft angle
- lateral view : less than 20 degree of angulation (Slight valgus means a valgus of no more 10 degrees)
- Criterion two (displacement) :
- Anterior posterior view: less than 4 mm of displacement of any fragment.
- Lateral view: less than 4 mm of displacement of any fragment.
- The reduction will be categorized as good if both criteria were met, acceptable if only one criterion was met, and poor if Neither criterion was met.
Measured: immediate postoperative
Fluoroscopic exposure time
The fluoroscopic exposure time is defined as: The total duration of fluoroscopy use in minutes during the set up and the surgical procedure.
Measured: intraoperative
Secondary outcomes (2)
Setup time
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.
Measured: Intraoperative
Surgical time
The time between the skin incision and the closure of the wound.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start30 Jun 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Intertrochanteric FractureStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr Ahmed Abd Elrahman Hasan, Professor of Orthopedics, Study director, Department of Orthoepdics - Faculty of Medicine - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410338
- Sponsor's protocol ID
- FMASU MS734/2023
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Femoral Nailing in Unstable Intertrochanteric Fractures: Lateral Decubitus Position Versus Supine Position on Traction Table.
- ClinicalTrials.gov ID
- NCT07410338
- Acronym / sponsor ID
- FMASU MS734/2023
- Conditions
- Unstable Intertrochanteric Fracture
- Keywords
- Unstable intertrochanteric fracture, Proximal femoral nail, proximal femoral fractures, traction table, lateral decubitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral postion during proximal femoral nailing for unstable intertrochnateric femur fractures | Active comparator | Procedure: lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fracturesProximal femoral nailing in lateral decubitus position |
| Supine postion using traction table in proximal femoral nailing intertrochanteric femur fractures | Active comparator | Procedure: Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction tableProximal femoral nailing in supine position using traction table |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Skeletally mature patients
- Unstable intertrochanteric fracture ( AO/OTA type 31A2 \& 31A3 )
Key exclusion criteria (3 listed)
- Patients unfit for surgery
- Revision cases
- Patients with multiple or pathological, neglected or open fractures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fracturesdifferent positions of the patient during the surgery | Procedure or surgery | Lateral postion during proximal femoral nailing for unstable intertrochnateric femur fractures |
| Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction tabledifferent positions for the proximal femoral nailing | Procedure or surgery | Supine postion using traction table in proximal femoral nailing intertrochanteric femur fractures |
Primary outcome
Quality of radiographic reduction
Time frame: immediate postoperative
Optimum Tip-to-apex distance (TAD) is 25mm or less. * Normal femoral neck shaft angle between 125 and 145 degree. * The Baumgartner reduction quality criteria : - 1. Criterion one (alignment) : 1. Anterior posterior view : normal or slight valgus neck shaft angle 2. lateral view : less than 20 degree of angulation (Slight valgus means a valgus of no more 10 degrees) 2. Criterion two (displacement) : 1. Anterior posterior view: less than 4 mm of displacement of any fragment. 2. Lateral view: less than 4 mm of displacement of any fragment. 3. The reduction will be categorized as good if both criteria were met, acceptable if only one criterion was met, and poor if Neither criterion was met.
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.
2 secondary outcomes
Setup time
Time frame: Intraoperative
Surgical time
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided. Not decided yet
Related trials for Unstable Intertrochanteric Fracture
Recruiting
InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
Fracture of Hip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Ahmed Abd Elrahman Hasan, Professor of Orthopedics study director
Department of Orthoepdics - Faculty of Medicine - Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fractures and Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction table in people with Unstable Intertrochanteric Fracture, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of radiographic reduction (time frame: immediate postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.