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
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
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014