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

Proximal Femur Fracture Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01235169
• Other study ID #: WEIL02-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: November 4, 2010
• Last updated: March 21, 2013

Study information

• Verified date: March 2013
• Source: Hadassah Medical Organization
• Contact: Yoram Weil
• Phone: 972-2-6776342
• Email: weily[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Proximal Femur Fracture

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organizaton	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).