Clinical trial NCT01127776: Bi-trimalleolar Fracture and APOS System Treatment
Official title: APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bi-trimalleolar Fracture of Ankle
Keywords: patient after bi-trimalleolar fracture of ankle
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: APOS System effects
timeFrame: one year
Secondary outcomes:
measure: Ankle fracture
timeFrame: one year
Other outcomes:
Locations:
city: Kfar - Saba
country: Israel
facility: Orthopaedic Department - Meir Medical Center
Study officials:
References:
citation: 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.