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

March 16, 2012 updated by: Meir Medical Center

APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Trial design Prospective, comparative, randomize trial. The patients after surgery due to bi or trimalleolar fracture of ankle, that were referred to the physiotherapy treatment, 3 weeks cast and 6 weeks from surgery with full weight bearing indicated by orthopedic

  • The population will randomized separated in trail and control group/ Both receive APOS shoes The trial group will receive APOS walking system

  • The control group will receive the same walking protocol as the trial group without biomechanics units.

    1. st visit: enrollment of patient - 6 weeks post op 1. The patient will be given a full verbal and written explanation regarding the trial and treatment. The patient will sign the informed consent form and will be given a serial number.

    2. The screening forms will be completed. 3. Demographic data: date of birth, sex, age and complete medical history, height and previous treatments will be recorded.

    4. Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF 5. Walking test using a laboratory walking GAITRite + 6 minute walk test 6. Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 7. Adjustment of Apos walking System

    2nd visit: 12 weeks post op

    1. Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
    2. Walking test using a laboratory walking GAITRite + 6 minute walk test
    3. Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC

    3rd visit: 3 month post op

    1. Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
    2. Walking test using a laboratory walking GAITRite + 6 minute walk test
    3. Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC

    4th visit: 6 month post op

    1. Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
    2. Walking test using a laboratory walking GAITRite + 6 minute walk test
    3. Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC

    5th visit: 12 month post op

    1. Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF 2. Walking test using a laboratory walking GAITRite + 6 minute walk test 3. Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC

    6th visit: 18 month post op

    1. Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
    2. Walking test using a laboratory walking GAITRite + 6 minute walk test
    3. Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC

    7th visit: 24 month post op

    1. Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
    2. Walking test using a laboratory walking GAITRite + 6 minute walk test
    3. Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar - Saba, Israel
        • Recruiting
        • Orthopaedic Department - Meir Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle fracture
Time Frame: one year
bi-trimalleolar ankle fracture - crif
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ANTICIPATED)

May 1, 2012

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (ESTIMATE)

May 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC9181-09CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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