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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
First received: November 4, 2010
Last updated: March 21, 2013
Last verified: March 2013

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

Condition Intervention Phase
Proximal Femur Fracture
Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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).

Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proximal Femoral Nail Antirotation
Proximal Femoral Nail Antirotation(PFNA) with cement augmentation
Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation


Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01235169

Contact: Yoram Weil 972-2-6776342 weily@hadassah.org.il

Hadassah Medical Organizaton Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01235169     History of Changes
Other Study ID Numbers: WEIL02-HMO-CTIL
Study First Received: November 4, 2010
Last Updated: March 21, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on December 01, 2015