Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture
Primary Purpose
Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur, Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
PFNA proximal femur nail device (Synthes)
INTERTAN proximal femur nail device (Smith&Nephew)
Sponsored by
About this trial
This is an interventional treatment trial for Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur focused on measuring proximal femur nail, pfna, intertan, weight bearing, pertrochanteric fracture, femur neck fracture
Eligibility 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
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PFNA
INTERTAN
Arm Description
these patients will be treated with "synthes" PFNA" device
these patients will be treated with Smith&Nephew "INTERTAN" device
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
complication
complication as non union, infection, cut-out will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01509859
Brief Title
Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture
Official Title
Prospective Randomized Trial Comparing the Weight Bearing After Fixation of Proximal Femur Fractures With Two Different Proximal Intramedullary Devices
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur, Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur
Keywords
proximal femur nail, pfna, intertan, weight bearing, pertrochanteric fracture, femur neck fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PFNA
Arm Type
Active Comparator
Arm Description
these patients will be treated with "synthes" PFNA" device
Arm Title
INTERTAN
Arm Type
Active Comparator
Arm Description
these patients will be treated with Smith&Nephew "INTERTAN" device
Intervention Type
Device
Intervention Name(s)
PFNA proximal femur nail device (Synthes)
Intervention Description
synthes "PFNA" proximal femur nail device
Intervention Type
Device
Intervention Name(s)
INTERTAN proximal femur nail device (Smith&Nephew)
Intervention Description
Smith&Nephew "INTERTAN" proximal femur nail device
Secondary Outcome Measure Information:
Title
complication
Description
complication as non union, infection, cut-out will be recorded
Time Frame
the patients will be measured during the hospital stay (average of 1 week) and at 6 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eliezer sidon, MD
Phone
972-523-896169
Email
elisid@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
yona kosashvili, MD
Phone
972-3-9376156
Email
yonako1@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yona kosashvili, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
eliezer sidon, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Rabin Medical Center
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
eliezer sidon, MD
Phone
972-3523-896169
Email
elisid@clalit.org.il
First Name & Middle Initial & Last Name & Degree
yona kosashvili, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16056089
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. doi: 10.1097/01.bot.0000172287.44278.ef.
Results Reference
background
PubMed Identifier
11886906
Citation
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.
Results Reference
background
PubMed Identifier
2302881
Citation
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.
Results Reference
background
PubMed Identifier
8110516
Citation
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.
Results Reference
background
PubMed Identifier
1644453
Citation
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.
Results Reference
background
PubMed Identifier
9531202
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. doi: 10.2106/00004623-199803000-00007.
Results Reference
background
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Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture
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