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

Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur Clinical Trial

Official title:

Prospective Randomized Trial Comparing the Weight Bearing After Fixation of Proximal Femur Fractures With Two Different Proximal Intramedullary Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01509859
• Other study ID #: 0333-11-RMC
• Status: Recruiting
• Phase: Phase 4
• First received: January 5, 2012
• Last updated: January 12, 2012
• Start date: December 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2012
• Source: Rabin Medical Center
• Contact: eliezer sidon, MD
• Phone: 972-523-896169
• Email: elisid[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur
• Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur
• Femoral Fractures
• Fractures, Bone
• Fractures, Comminuted
• Hip Fractures

Intervention

Device:
• PFNA proximal femur nail device (Synthes)
synthes "PFNA" proximal femur nail device
• INTERTAN proximal femur nail device (Smith&Nephew)
Smith&Nephew "INTERTAN" proximal femur nail device

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	complication	complication as non union, infection, cut-out will be recorded	the patients will be measured during the hospital stay (average of 1 week) and at 6 weeks after surgery	Yes