New Method for Distal Interlocking of Cannulated Intramedullary Nails
|ClinicalTrials.gov Identifier: NCT00648479|
Recruitment Status : Terminated (the company does not want to proceed yet with the study)
First Posted : April 1, 2008
Last Update Posted : December 28, 2011
We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study.
Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:"The Guiding star" method.
The allocation will be random.
|Condition or disease||Intervention/treatment||Phase|
|Fracture||Device: The Guiding Star Device: fluoroscopy (OEC 9800 - General Electric)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||New Method for Distal Interlocking of Cannulated Intramedullary Nails|
|Experimental: 1||Device: The Guiding Star|
|Active Comparator: 2||Device: fluoroscopy (OEC 9800 - General Electric)|
- the outcome will be asses using regular fluoroscopy in the operation room.