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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
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Femur Fracture

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 4, 2010
Last Updated
March 21, 2013
Sponsor
Hadassah Medical Organization
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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

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