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

Phase 1

• Conditions: Proximal Femur Fracture
• Interventions: Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

• Registration Number: NCT01235169
• Lead Sponsor: Hadassah Medical Organization

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:

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22
• Primary Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proximal Femoral Nail Antirotation	Proximal Femoral Nail Antirotation(PFNA) with cement augmentation	Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hadassah Medical Organizaton; 🇮🇱 Jerusalem, Israel