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Trial record 98 of 115 for:    Recruiting, Not yet recruiting, Available Studies | "Hip Fractures"

Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly.

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ClinicalTrials.gov Identifier: NCT02577081
Recruitment Status : Recruiting
First Posted : October 16, 2015
Last Update Posted : September 20, 2016
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by (Responsible Party):
niv marom, Meir Medical Center

Brief Summary:
Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this study is to evaluate the risk of a contralateral neck of femur fracture after the first neck of femur fracture and to estimate the potential fracture characteristics.

Condition or disease Intervention/treatment Phase
Neck of Femur Fracture Other: CAT scan (CT scan) Not Applicable

Detailed Description:
Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. literature shows that around 10 percent of those who fracture their femoral neck for the first time will later fracture their contralateral neck of femur and in most cases with the same fracture characteristics. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this study is to evaluate the risk of a contralateral neck of femur fracture after the first neck of femur fracture and to estimate the potential fracture characteristics.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly. CT Based Study.
Study Start Date : January 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CAT scan
A CAT scan will be done for all participants. The scan will include the pelvis and 2 femurs.
Other: CAT scan (CT scan)
all patients will pass a CAT scan of ths pelvis and the 2 femurs. No other interventions are required.




Primary Outcome Measures :
  1. The risk of a contralateral neck of femur fracture [ Time Frame: 5 years ]
    A patient specific analysis based on CT scan and finite element analysis will be done on both neck of femurs.


Secondary Outcome Measures :
  1. 3 dimensional charataristics of the neck of femur fracture [ Time Frame: 1 year ]
    The CAT scan will provide 3 dimensional characteristics of the current neck of femur fracture as well as the predicted one in the contralateral femur. The fracture will be described using orthopaedic classifications, such as: garden classification for neck of femur fractures and AO classification for intertrochanteric fractures of the femur.



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Ages Eligible for Study:   70 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 70-90 years old patients admitted to the orthopaedic department after neck of femur fracture.
  • No contra lateral femur pathology.
  • Consent for pelvis and femurs CAT scan.

Exclusion Criteria:

  • Known pathology in other lower limbs joints in the body.
  • History of previous fractures or operations in lower limbs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577081


Contacts
Contact: Niv Marom, M.D +972-52-2228627 niv.marom@gmail.com

Locations
Israel
Meir medical center Recruiting
Kfar Saba, Israel, 44538
Contact: Niv Marom, MD    +972-9-7471888    niv.marom@gmail.com   
Sponsors and Collaborators
Meir Medical Center
Ben-Gurion University of the Negev
Investigators
Study Chair: niv marom, MD meir medical cenrter

Publications:
Responsible Party: niv marom, Niv marom, Resident, Department of Orthopaedic surgery, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02577081     History of Changes
Other Study ID Numbers: 0163-15-MMC
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Femoral Neck Fractures
Wounds and Injuries
Leg Injuries
Hip Fractures
Hip Injuries