Radiological and Functional Outcomes of Internal Fixation Methods for Ipsilateral Femoral Neck and Shaft Fractures in Young Adult Patients

February 12, 2025 updated by: Abanoub Ibrahim khalifa yakoup, Assiut University
Does the single construct produce more favourable radiological and functional outcomes with less complication when it is compared to dual constructs for fixation of ipsilateral femoral neck and shaft fractures in young adult patients at one year follow up?

Study Overview

Detailed Description

The investigators will do follow up for internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients at one year and observe does single construct will give favourable outcomes versus dual constructs?

Study Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Mahmoud Youssef Badran, Assistant Professor
  • Phone Number: +201000341878
  • Email: m_badran80@yahoo.com

Study Locations

      • Assiut, Egypt
        • Assiut 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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Young adult patients from 18- 55 years old not more than and not less Not with comrbodities like uncontrolled diabetes,renal disease and neurological deficits.

Description

Inclusion Criteria:

  • Age of the patients from 18 to 55 years
  • Recent fracture within one week
  • Ipsilateral Neck and shaft femur fractures according to AO Classification including 31 B (all types of neck ) and 32 A,B and C ( all types of shaft femur )

Exclusion Criteria:

  • Open fractures GIII
  • patients more than 55 and less than 18 years old
  • Patient with comorbidities: uncontrolled D.M, renal patient, neurological deficits.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
I will compare results with favourable outcomes between single and dual constructs
Single construct like cephalomedullary nail or long DHS in fixation of both neck and shaft fractures, dual constructs like DHS or cannulated screws and retrograde nail or DHS or cannulated screws and dymanic compression plate in fixation of both fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological union evaluation
Time Frame: Assessment of radiological union and the time will be taken at one year follow up

Radiographic union evaluation of ipsilateral neck and shaft femur fractures after internal fixation methods at one year follow up in young adult patients using :

Radiographic union score of the hip for neck fracture Radiographic union score for the femur fracture. Minimum score for these scales is 10 and maximum is 30 High score means good outcome

Assessment of radiological union and the time will be taken at one year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: One year follow up
Functional outcome will be assessed after internal fixation methods for ipsilateral femoral neck and shaft fractures in young adult patients using friedman and wyman scale to assess whether patients have pain , Impaired daily life activities and loss of hip and knee range of motion . this scale is categorised by good, fair and poor outcome Good which have no pain no impaired daily life activities and less than 20 % loss of hip and knee range of motion Fair mild impaired daily life activities, mild to moderate pain and 20_50% loss of hip and knee range of motion Poor moderate impaired daily life activities, severe pain and more than 50% loss of hip and knee range of motion.
One year follow up
Complications
Time Frame: One year follow up
Complications will be reported if occured like non- union, infection and avascular necrosis of the neck.
One year follow up

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.

Helpful Links

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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