Bi-trimalleolar Fracture and APOS System Treatment

Bi-trimalleolar Fracture of Ankle Clinical Trial

— APOS-IL 001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01127776
• Other study ID #: MMC9181-09CTIL
• Status: Recruiting
• Phase: Phase 1
• First received: April 27, 2010
• Last updated: March 16, 2012
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIsrael: The Israel National Institute for Health Policy Research and Health Services ResearchIsrael: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Bi-trimalleolar Fracture of Ankle
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Israel	Orthopaedic Department - Meir Medical Center	Kfar - Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Ankle fracture	bi-trimalleolar ankle fracture - crif	one year	Yes