Bi-trimalleolar Fracture and APOS System Treatment (APOS-IL 001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01127776|
Recruitment Status : Unknown
Verified March 2012 by Meir Medical Center.
Recruitment status was: Recruiting
First Posted : May 21, 2010
Last Update Posted : March 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bi-trimalleolar Fracture of Ankle||Device: APOS SYSTEM Other: APOS SYSTEM without biomechanics units.||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||May 2012|
|Experimental: Apos System||
Device: APOS SYSTEM
The trial group will receive APOS walking system The control group will receive the same walking protocol as the trial group without biomechanics units
|Placebo Comparator: CONTROL||
Other: APOS SYSTEM without biomechanics units.
The control group will receive the same walking protocol as the trial group without biomechanics units
- APOS System effects [ Time Frame: one year ]
Evaluate with functional tests and clinical findings patient after bi-trimalleolar fracture of ankle with who recive APOS System treatment.
Functional changes will be evaluated using FAOS, SF36 and WOMAC scores, walking laboratory GAITRite and clinical examination.
- Ankle fracture [ Time Frame: one year ]bi-trimalleolar ankle fracture - crif
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127776
|Orthopaedic Department - Meir Medical Center||Recruiting|
|Kfar - Saba, Israel|
|Contact: Ezequiel Palmanovich, md firstname.lastname@example.org|