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Trials / Unknown

UnknownNCT01235169

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

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
Sponsor
Hadassah Medical Organization · Academic / Other
Sex
All
Age
60 Years – 90 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEProximal Femoral Nail Antirotation(PFNA) with cement augmentation

Timeline

Primary completion
2015-03-01
First posted
2010-11-05
Last updated
2013-03-22

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT01235169. Inclusion in this directory is not an endorsement.

Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures (NCT01235169) · Clinical Trials Directory