Bi-trimalleolar Fracture of Ankle Clinical Trial
Official title:
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.
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
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment