NCT01127776

Bi-trimalleolar Fracture and APOS System Treatment

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Bi-trimalleolar Fracture of Ankle

Interventions

Type	Name	Description
DEVICE	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
OTHER	APOS SYSTEM without biomechanics units.	The control group will receive the same walking protocol as the trial group without biomechanics units

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-03-01
• Completion: 2012-05-01
• First posted: 2010-05-21
• Last updated: 2012-03-19

Locations

1 site across 1 country: Israel