Bi-trimalleolar Fracture and APOS System Treatment (APOS-IL 001)
APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study
Study Overview
Status
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.
- 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
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Kfar - Saba, Israel
- Recruiting
- Orthopaedic Department - Meir Medical Center
-
Contact:
- Ezequiel Palmanovich, MD
- Email: ezepalm@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
The control group will receive the same walking protocol as the trial group without biomechanics units
|
|
EXPERIMENTAL: 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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC9181-09CTIL
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