Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures
Primary Purpose
Proximal Femur Fracture
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Proximal Femoral Nail Antirotation(PFNA) with cement augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Femur Fracture
Eligibility Criteria
Inclusion Criteria:
- PFNA augmentation is indicated for severe osteoporotic fractures (Subtrochanteric or intertrochanteric) in the proximal femur.
- Men and women above 80 years old that fuffer from fracture in the proximal femur.
Exclusion Criteria:
- Patient can not come to the follow up clinic visits.
Sites / Locations
- Hadassah Medical Organizaton
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proximal Femoral Nail Antirotation
Arm Description
Proximal Femoral Nail Antirotation(PFNA) with cement augmentation
Outcomes
Primary Outcome Measures
Proportion of patients reaching union at the 3-month and 6-month follow up
Proportion of patients reaching union at the 3-month and 6-month follow up will be assessed. Union is defined by both clinical evaluation-pain and weight bearing status, and radiological evaluation- three out of four cortices must be bridged as viewed on plain X-ray (AP and lateral views).
Secondary Outcome Measures
Full Information
NCT ID
NCT01235169
First Posted
November 4, 2010
Last Updated
March 21, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01235169
Brief Title
Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
Brief Summary
This is an open multicenter study, evaluating a new operative technique in femur neck fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures:
Insertion an intramedullary nail (without augmentation) to the bone.
insertion a nail and metal plateto the bone. The major disadvantage of these methods is the relative high rate (4-10 precentages) of failure because of the femur head bone which is very brittle and osteoporotic.
This new approach enables the nail a better grip as a result of the cement augmentation which consists of PMMA (Polymethyl methacrylate).
The investigators main goal is to evaluate the use of this surgical technique
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Femur Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
8. Arms, Groups, and Interventions
Arm Title
Proximal Femoral Nail Antirotation
Arm Type
Experimental
Arm Description
Proximal Femoral Nail Antirotation(PFNA) with cement augmentation
Intervention Type
Device
Intervention Name(s)
Proximal Femoral Nail Antirotation(PFNA) with cement augmentation
Primary Outcome Measure Information:
Title
Proportion of patients reaching union at the 3-month and 6-month follow up
Description
Proportion of patients reaching union at the 3-month and 6-month follow up will be assessed. Union is defined by both clinical evaluation-pain and weight bearing status, and radiological evaluation- three out of four cortices must be bridged as viewed on plain X-ray (AP and lateral views).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PFNA augmentation is indicated for severe osteoporotic fractures (Subtrochanteric or intertrochanteric) in the proximal femur.
Men and women above 80 years old that fuffer from fracture in the proximal femur.
Exclusion Criteria:
Patient can not come to the follow up clinic visits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoram Weil
Phone
972-2-6776342
Email
weily@hadassah.org.il
Facility Information:
Facility Name
Hadassah Medical Organizaton
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures
We'll reach out to this number within 24 hrs