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Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures

NCT01235169 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2013-03-22

No results posted yet for this study

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:

1. Insertion an intramedullary nail (without augmentation) to the bone.
2. 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

Conditions

  • Proximal Femur Fracture

Interventions

DEVICE

Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2015-03-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235169 on ClinicalTrials.gov