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

This study is not yet open for participant recruitment.

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

History of Changes

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:

Insertion an intramedullary nail (without augmentation) to the bone.
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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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

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
Femoral Neck Fractures
Fractures, Bone

Wounds and Injuries
Leg Injuries
Hip Fractures

ClinicalTrials.gov processed this record on May 23, 2013

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