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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Detailed Description

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Conditions

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Proximal Femur Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Proximal Femoral Nail Antirotation

Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Group Type EXPERIMENTAL

Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Intervention Type DEVICE

Interventions

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Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Intervention Type DEVICE

Eligibility Criteria

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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.