Bi-trimalleolar Fracture and APOS System Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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 Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF Walking test using a laboratory walking GAITRite + 6 minute walk test Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 3rd visit: 3 month post op Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF Walking test using a laboratory walking GAITRite + 6 minute walk test Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 4th visit: 6 month post op Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF Walking test using a laboratory walking GAITRite + 6 minute walk test 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 Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF Walking test using a laboratory walking GAITRite + 6 minute walk test Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 7th visit: 24 month post op Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF Walking test using a laboratory walking GAITRite + 6 minute walk test Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC

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

Conditions
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Bi-trimalleolar Fracture of Ankle

Intervention / Treatment
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* Device: APOS SYSTEM
* Other: APOS SYSTEM without biomechanics units.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apos System<br> | Device: APOS SYSTEM<br>* The trial group will receive APOS walking system The control group will receive the same walking protocol as the trial group without biomechanics units<br>|
| Placebo Comparator: CONTROL<br> | Other: APOS SYSTEM without biomechanics units.<br>* The control group will receive the same walking protocol as the trial group without biomechanics units<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APOS System effects | 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 | bi-trimalleolar ankle fracture - crif | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient after bi-trimalleolar fracture of ankle