Bi-trimalleolar Fracture and APOS System Treatment (APOS-IL 001)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01127776
First received: April 27, 2010
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Bi-trimalleolar Fracture of Ankle
Device: APOS SYSTEM
Other: APOS SYSTEM without biomechanics units.
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • APOS System effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]

    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:
  • Ankle fracture [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    bi-trimalleolar ankle fracture - crif


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: May 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01127776     History of Changes
Other Study ID Numbers: MMC9181-09CTIL
Study First Received: April 27, 2010
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on September 18, 2014