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

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Proximal Femur Fracture

Treatments: Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT01235169

WEIL02-HMO-CTIL

Details and patient eligibility

About

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

Sex: All

Ages: 60 to 90 years old

Volunteers: No 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.

Trial design

0 participants in 1 patient group

Proximal Femoral Nail Antirotation

Experimental group

Description:

Proximal Femoral Nail Antirotation(PFNA) with cement augmentation

Treatment:

Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation