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Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01509859
Recruitment Status : Unknown
Verified January 2012 by yona kosashvili, Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : January 13, 2012
Last Update Posted : January 13, 2012
Information provided by (Responsible Party):
yona kosashvili, Rabin Medical Center

Brief Summary:
The purpose of the study is to Compare the stability of the fracture and pain after surgery by measuring the stride length and weight bearing on the operated leg. This study will compare these parameters between two different proximal femur nails used for fixing hip fractures.

Condition or disease Intervention/treatment Phase
Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur Device: PFNA proximal femur nail device (Synthes) Device: INTERTAN proximal femur nail device (Smith&Nephew) Phase 4

Detailed Description:

Fractures of the proximal femur and hip are relatively common injuries in adults.

According to the Evans and the AO Classification systems, the fracture can be described as stable after reduction or not according to the direction of the fracture lines and the comminution of the medial cortex or the lateral wall of the proximal femur.

Biomechanically, nails allow for stable anatomical fixation of more comminuted fractures without shortening the abductor moment arm or changing the proximal femoral anatomy. These devices provide fracture stability by virtue of allowing the lateral aspect of the head and neck to come to rest against the nail in the medullary canal.

For fractures with comminuted medial cortex or involvement of the lateral cortex (AO 2.2 - AO 3.3) it is advisable to fixate with a more stable fixation device such as intramedullary proximal femur nail Several intramedullary devices are currently in use for the treatment of the intertrochanteric fractures. In our institution, for the unstable fracture we use either one of the intramedullary devices manufactured by Synthes (Proximal femoral nail - anti-rotation = PFNA) or by Smith&Nephew (Trochanteric Antegrade Nail = InterTan).

Each of these nails allow compression over the Nail\Blade with the intramedullary stability.

There are 3 main complications in the treatment of intramedullary devices : (1) varus collapse of the head/neck, (2) uncontrolled shortening of the neck, and (3)femoral shaft fractures at the tip of the nail The InterTan, unlike other devices, allows for immediate intraoperative compression of the principal fracture fragments through linear compression combined with rotational stability secondary to its unique geometry and mechanism of action.

The mechanical stability of the fracture after the fixation is reflected by the weight bearing the patient can hold . In order to find weather there is a mechanical difference between the two devices we would like to perform a test measuring the weight bearing after fixation of intertrochanteric fractures comparing the pain and impression of mechanical stability in the two devices.

The method to test the amount of weight bearing would be using the "SmartStep gait system" TM (Andante Medical Devices Ltd), an innovative biofeedback and monitoring system that records and analyzes key gait parameters and provides instantaneous and accurate audio and visual feedback.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing the Weight Bearing After Fixation of Proximal Femur Fractures With Two Different Proximal Intramedullary Devices
Study Start Date : December 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: PFNA
these patients will be treated with "synthes" PFNA" device
Device: PFNA proximal femur nail device (Synthes)
synthes "PFNA" proximal femur nail device

Active Comparator: INTERTAN
these patients will be treated with Smith&Nephew "INTERTAN" device
Device: INTERTAN proximal femur nail device (Smith&Nephew)
Smith&Nephew "INTERTAN" proximal femur nail device

Secondary Outcome Measures :
  1. complication [ Time Frame: the patients will be measured during the hospital stay (average of 1 week) and at 6 weeks after surgery ]
    complication as non union, infection, cut-out will be recorded

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • pertrochanteric fracture ao 2.2 and above
  • ambulatory patient, without support prior to the fall
  • minor trauma mechanism
  • without other injuries
  • operated 3 days from the injury

Exclusion Criteria:

  • dementia
  • s/p hip or knee arthroplasty
  • known osteoarthritis

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 identifier (NCT number): NCT01509859

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Contact: eliezer sidon, MD 972-523-896169
Contact: yona kosashvili, MD 972-3-9376156

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Rabin Medical Center Recruiting
Petach-Tikva, Israel, 49100
Contact: eliezer sidon, MD    972-3523-896169   
Principal Investigator: yona kosashvili, MD         
Sponsors and Collaborators
Rabin Medical Center
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Principal Investigator: yona kosashvili, MD Rabin Medical Center
Study Director: eliezer sidon, MD Rabin Medical Center

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Responsible Party: yona kosashvili, senior surgeon, joint arthroplasty unit, orthopedic department, Rabin Medical Center Identifier: NCT01509859     History of Changes
Other Study ID Numbers: 0333-11-RMC
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012
Keywords provided by yona kosashvili, Rabin Medical Center:
proximal femur nail
weight bearing
pertrochanteric fracture
femur neck fracture
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Hip Fractures
Fractures, Comminuted
Wounds and Injuries
Leg Injuries
Hip Injuries