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

Hadassah Medical Organization

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Conditions

Proximal Femur Fracture

Interventions

Proximal Femoral Nail Antirotation(PFNA) with cement augmentationDEVICE

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hadassah Medical Organizaton

Jerusalem, Israel

Outcomes

Primary Outcomes

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).

Central Contacts

Yoram Weil

CONTACT

972-2-6776342 weily@hadassah.org.il

Data from ClinicalTrials.gov

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