- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01509859
Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture
Prospective Randomized Trial Comparing the Weight Bearing After Fixation of Proximal Femur Fractures With Two Different Proximal Intramedullary Devices
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: eliezer sidon, MD
- Phone Number: 972-523-896169
- Email: elisid@clalit.org.il
Study Contact Backup
- Name: yona kosashvili, MD
- Phone Number: 972-3-9376156
- Email: yonako1@clalit.org.il
Study Locations
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Petach-Tikva, Israel, 49100
- Recruiting
- Rabin Medical Center
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Contact:
- eliezer sidon, MD
- Phone Number: 972-3523-896169
- Email: elisid@clalit.org.il
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Principal Investigator:
- yona kosashvili, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: PFNA
these patients will be treated with "synthes" PFNA" device
|
synthes "PFNA" proximal femur nail device
|
ACTIVE_COMPARATOR: INTERTAN
these patients will be treated with Smith&Nephew "INTERTAN" device
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Smith&Nephew "INTERTAN" proximal femur nail device
|
What is the study measuring?
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
the patients will be measured during the hospital stay (average of 1 week) and at 6 weeks after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: yona kosashvili, MD, Rabin Medical Center
- Study Director: eliezer sidon, MD, Rabin Medical Center
Publications and helpful links
General 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. doi: 10.1097/01.bot.0000172287.44278.ef.
- Sadowski C, Lubbeke 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(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 Malmo, Sweden (1950-1991). Bone. 1993;14 Suppl 1:S23-9. doi: 10.1016/8756-3282(93)90345-b.
- Williams WW, Parker BC. Complications associated with the use of the gamma nail. Injury. 1992;23(5):291-2. doi: 10.1016/0020-1383(92)90169-s.
- 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. doi: 10.2106/00004623-199803000-00007.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0333-11-RMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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