Bi-trimalleolar Fracture of AnklePhase 1APOS-IL 001NCT01127776
Bi-trimalleolar Fracture and APOS System Treatment
A Phase 1 study testing APOS SYSTEM and APOS SYSTEM without biomechanics units. in people with Bi-trimalleolar Fracture of Ankle, run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bi-trimalleolar Fracture of Ankle
- What is being tested?
- APOS SYSTEM and APOS SYSTEM without biomechanics units.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Orthopaedic Department - Meir Medical Center
Kfar Saba
Ezequiel Palmanovich, md, ezepalm@gmail.com
About this study
Official title: APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study
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.
- 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.
- 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.
- 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
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 3rd visit: 3 month post op
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 4th visit: 6 month post op
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 5th visit: 12 month post op
- 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
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 7th visit: 24 month post op
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC
- Conditions
- Bi-trimalleolar Fracture of Ankle
- Being tested
- APOS SYSTEM, APOS SYSTEM without biomechanics units.
- Keywords
- patient after bi-trimalleolar fracture of ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APOS SYSTEMDevice
The trial group will receive APOS walking system The control group will receive the same walking protocol as the trial group without biomechanics units
APOS SYSTEM without biomechanics units.Other
The control group will receive the same walking protocol as the trial group without biomechanics units
| Study group | Role | What they receive |
|---|---|---|
| Apos System | Experimental | Not described Receives: Device: APOS SYSTEM |
| CONTROL | Placebo comparator | Not described Receives: Other: APOS SYSTEM without biomechanics units. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
Ankle fracture
bi-trimalleolar ankle fracture - crif
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bi-trimalleolar Fracture of AnkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127776
- Sponsor's protocol ID
- MMC9181-09CTIL
- Acronym
- APOS-IL 001
- Status last verified
- Mar 2012
- First submitted
- 27 Apr 2010
- Last updated
- 19 Mar 2012
- Results posted
- No
Publications
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.
PubMed 39312389Segal 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study
- ClinicalTrials.gov ID
- NCT01127776
- Acronym / sponsor ID
- APOS-IL 001 / MMC9181-09CTIL
- Conditions
- Bi-trimalleolar Fracture of Ankle
- Keywords
- patient after bi-trimalleolar fracture of ankle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 3rd visit: 3 month post op
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 4th visit: 6 month post op
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 5th visit: 12 month post op
- 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
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC 7th visit: 24 month post op
- Physical examination: range of motion, Achilles tendon thickness. The results will be recorded in the CRF
- Walking test using a laboratory walking GAITRite + 6 minute walk test
- Fill out questionnaire: FAOS - AOSF - SF36 - WOMAC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apos System | Experimental | Device: APOS SYSTEM |
| CONTROL | Placebo comparator | Other: APOS SYSTEM without biomechanics units. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APOS SYSTEMThe trial group will receive APOS walking system The control group will receive the same walking protocol as the trial group without biomechanics units | Device | Apos System |
| APOS SYSTEM without biomechanics units.The control group will receive the same walking protocol as the trial group without biomechanics units | Other | CONTROL |
Primary outcome
APOS System effects
Time frame: one year
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.
1 secondary outcome
Ankle fracture
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Derived from this study: PubMed 39312389Lewis 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.
- Derived from this study: PubMed 25478013Segal 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.
Related trials for Bi-trimalleolar Fracture of Ankle
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Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APOS SYSTEM and APOS SYSTEM without biomechanics units. in people with Bi-trimalleolar Fracture of Ankle, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APOS System effects (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.