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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01235169
First received: November 4, 2010
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
Israel
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 October 23, 2014