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

Clalit Health Services

Status and phase

Unknown

Phase 1

Conditions

Bi-trimalleolar Fracture of Ankle

Treatments

Device: APOS SYSTEM

Other: APOS SYSTEM without biomechanics units.

Study type

Interventional

Funder types

Other

Identifiers

NCT01127776

MMC9181-09CTIL

Details and patient eligibility

About

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.

Full 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.
3. 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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.