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Status unknownNCT01127776APOS-IL 001Updated Mar 19, 2012

Bi-trimalleolar Fracture and APOS System Treatment

A Phase 1 interventional study of APOS SYSTEM and APOS SYSTEM without biomechanics units. in Bi-trimalleolar Fracture of Ankle, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-19.

Sponsored by Meir Medical Center · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.
    1. 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.
    1. 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
02

Conditions studied

  • Bi-trimalleolar Fracture of Ankle

Keywords

  • patient after bi-trimalleolar fracture of ankle
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 60 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Apos System

    Device: APOS SYSTEM

  • Placebo comparator
    CONTROL

    Other: APOS SYSTEM without biomechanics units.

Interventions

  • DeviceAPOS 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

  • OtherAPOS SYSTEM without biomechanics units.

    The control group will receive the same walking protocol as the trial group without biomechanics units

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one year

Secondary outcomes

  1. Ankle fracture

    bi-trimalleolar ankle fracture - crif

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Orthopaedic Department - Meir Medical Center
    Kfar - Saba, Israel
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25478013 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01127776
Lead sponsor
Meir Medical Center
Responsible party
Sponsor
First posted
May 21, 2010
Start date
Oct 2010
Primary completion
Mar 2011
Completion
May 2012 (estimated)
Last update
Mar 19, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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