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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.
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.
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
3rd visit: 3 month post op
4th visit: 6 month post op
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
7th visit: 24 month post op
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apos System | Experimental |
| |
| CONTROL | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APOS SYSTEM | Device | The trial group will receive APOS walking system The control group will receive the same walking protocol as the trial group without biomechanics units |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle fracture | bi-trimalleolar ankle fracture - crif | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Department - Meir Medical Center | Recruiting | Kfar Saba | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39312389 | Derived | Lewis SR, Pritchard MW, Parker R, Searle HKC, Beckenkamp PR, Keene DJ, Bretherton C, Lin CC. Rehabilitation for ankle fractures in adults. Cochrane Database Syst Rev. 2024 Sep 23;9(9):CD005595. doi: 10.1002/14651858.CD005595.pub4. | |
| 25478013 | Derived | Segal G, Elbaz A, Parsi A, Heller Z, Palmanovich E, Nyska M, Feldbrin Z, Kish B. Clinical outcomes following ankle fracture: a cross-sectional observational study. J Foot Ankle Res. 2014 Nov 28;7(1):50. doi: 10.1186/s13047-014-0050-9. eCollection 2014. |
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| APOS SYSTEM without biomechanics units. | Other | The control group will receive the same walking protocol as the trial group without biomechanics units |
|