We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:
The purpose of this study is to evaluate of functional tests and clinical findings with APOS System treatment in patient after bi-trimalleolar fracture of ankle. These functional changes will be evaluated AOFS, FAOS, SF36 and WOMAC scores, walking laboratory GAITRite and clinical examination.

Condition or disease Intervention/treatment Phase
Bi-trimalleolar Fracture of Ankle Device: APOS SYSTEM Other: APOS SYSTEM without biomechanics units. Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study
Study Start Date : October 2010
Primary Completion Date : March 2011
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Ankle fracture [ Time Frame: one year ]
    bi-trimalleolar ankle fracture - crif



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients 18-65 year old
  • Post operation bi- trimalleolar fracture of ankle
  • Download cast after 3 weeks
  • Full Weight bearing after 6 weeks
  • Patients in medical condition to receive physiotherapy treatment
  • Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.

Exclusion Criteria:

  • Patients suffering muscular or nerve disorders
  • Patients who are unable to use the APOS SYSTEM and can not complete the experimental protocol due to physical or mental handicap
  • Non cooperative patient with the basic rehab program.

Information from the National Library of Medicine

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


Locations
Israel
Orthopaedic Department - Meir Medical Center Recruiting
Kfar - Saba, Israel
Contact: Ezequiel Palmanovich, md       ezepalm@gmail.com   
Sponsors and Collaborators
Meir Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01127776     History of Changes
Other Study ID Numbers: MMC9181-09CTIL
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012

Keywords provided by Meir Medical Center:
patient after bi-trimalleolar fracture of ankle

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries