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

Study Description

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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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	60 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. Review.

Sadowski C, Lübbeke A, Saudan M, Riand N, Stern R, Hoffmeyer P. Treatment of reverse oblique and transverse intertrochanteric fractures with use of an intramedullary nail or a 95 degrees screw-plate: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84-A(3):372-81.

Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop Relat Res. 1990 Mar;(252):163-6.

Gullberg B, Duppe H, Nilsson B, Redlund-Johnell I, Sernbo I, Obrant K, Johnell O. Incidence of hip fractures in Malmö, Sweden (1950-1991). Bone. 1993;14 Suppl 1:S23-9.

Williams WW, Parker BC. Complications associated with the use of the gamma nail. Injury. 1992;23(5):291-2.

Koval KJ, Sala DA, Kummer FJ, Zuckerman JD. Postoperative weight-bearing after a fracture of the femoral neck or an intertrochanteric fracture. J Bone Joint Surg Am. 1998 Mar;80(3):352-6.

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
First Posted:	January 13, 2012
Last Update Posted:	January 13, 2012
Last Verified:	January 2012

Keywords provided by yona kosashvili, Rabin Medical Center:

proximal femur nail; pfna; intertan	weight bearing; pertrochanteric fracture; femur neck fracture

Additional relevant MeSH terms:

Fractures, Bone; Femoral Fractures; Hip Fractures; Fractures, Comminuted	Wounds and Injuries; Leg Injuries; Hip Injuries