NCT07410338

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 8, 2026

Last Update Submit

February 8, 2026

Conditions

Keywords

Unstable intertrochanteric fractureProximal femoral nailproximal femoral fracturestraction tablelateral decubitus

Outcome Measures

Primary Outcomes (2)

  • 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 : - 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.

    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.

    intraoperative

Secondary Outcomes (2)

  • Setup time

    Intraoperative

  • Surgical time

    Intraoperative

Study Arms (2)

Lateral postion during proximal femoral nailing for unstable intertrochnateric femur fractures

ACTIVE COMPARATOR

Proximal femoral nailing in lateral decubitus position

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

Procedure: Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction table

Interventions

different positions of the patient during the surgery

Lateral postion during proximal femoral nailing for unstable intertrochnateric femur fractures

different positions for the proximal femoral nailing

Supine postion using traction table in proximal femoral nailing intertrochanteric femur fractures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Skeletally mature patients
  • Unstable intertrochanteric fracture ( AO/OTA type 31A2 \& 31A3 )

You may not qualify if:

  • Patients unfit for surgery
  • Revision cases
  • Patients with multiple or pathological, neglected or open fractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck FracturesHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Amr Ahmed Abd Elrahman Hasan, Professor of Orthopedics

    Department of Orthoepdics - Faculty of Medicine - Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 13, 2026

Study Start

June 30, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations