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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
yona kosashvili, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01509859
First received: January 5, 2012
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

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


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509859

Contacts
Contact: eliezer sidon, MD 972-523-896169 elisid@clalit.org.il
Contact: yona kosashvili, MD 972-3-9376156 yonako1@clalit.org.il

Locations
Israel
Rabin Medical Center Recruiting
Petach-Tikva, Israel, 49100
Contact: eliezer sidon, MD    972-3523-896169    elisid@clalit.org.il   
Principal Investigator: yona kosashvili, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: yona kosashvili, MD Rabin Medical Center
Study Director: eliezer sidon, MD Rabin Medical Center
  More Information

Publications:
Responsible Party: yona kosashvili, senior surgeon, joint arthroplasty unit, orthopedic department, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01509859     History of Changes
Other Study ID Numbers: 0333-11-RMC
Study First Received: January 5, 2012
Last Updated: January 12, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
proximal femur nail
pfna
intertan
weight bearing
pertrochanteric fracture
femur neck fracture

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

ClinicalTrials.gov processed this record on November 20, 2014