Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures
Recruitment status was: Not yet recruiting
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
|Proximal Femur Fracture||Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Primary Purpose: Treatment
- Proportion of patients reaching union at the 3-month and 6-month follow upProportion 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)|
Experimental: Proximal Femoral Nail Antirotation
Proximal Femoral Nail Antirotation(PFNA) with cement augmentation
|Device: Proximal Femoral Nail Antirotation(PFNA) with cement augmentation|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235169
|Contact: Yoram Weilfirstname.lastname@example.org|
|Hadassah Medical Organizaton||Not yet recruiting|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 email@example.com|