Metatarsus AdductusNCT01600183
Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
A study testing UNFO-s and cast in people with Metatarsus Adductus and Metatarsus Varus, run by Unfo Ltd. at 1 site in Israel.
Trial summary
This is a prospective, randomized, control, open label study in which up to 50 subjects with metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard casting or using the UNFO-s device for total time of 20 weeks. Read more about this study
- Who is it for?
- Ages 1 month to 4 months
- Conditions the study is for
- Metatarsus Adductus, Metatarsus Varus
- What is being tested?
- UNFO-s and cast
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Aug 2013
- Phase
- Interventional
- 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 1 month to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects with an acute MTA that did not receive any treatment for this condition
- Consenting parents
- Ages 1-4 months
Who cannot join
- Participation in another clinical trial.
- Neuromuscular disorders
- Any condition which in the opinion of the investigator renders the subject ineligible for study participation.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka MC
Beersheba
Dan Atar, Prof, 972-50-6264277, dan_atar@yahoo.com
About this study
This is a prospective, randomized, control, open label study in which up to 50 subjects with metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard casting or using the UNFO-s device for total time of 20 weeks.
- Conditions
- Metatarsus Adductus, Metatarsus Varus
- Being tested
- UNFO-s, cast
- Keywords
- MTA, metatarsus, Metatarsus Adductus, also known as Metatarsus Varus
- Medical subject headings
- Metatarsus Varus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNFO-sDevice
The UNFO-s is a foot orthosis used to treat congenital foot malformations in infants
castProcedure or surgery
casting of the infant legs
| Study group | Role | What they receive |
|---|---|---|
| casting | Active comparator | subjects with MTA will be treated with cast for 20 weeks. casting is replaced during every study visit. Receives: Procedure: cast |
| UNFO-s | Experimental | subjects with MTA will be treated with the UNFO-s device for 12 weeks - will be worn day and night during first 6 weeks and only at night during next 6 weeks Receives: Device: UNFO-s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of the MTA
Healing of the MTA: straightening of the foot with apprx. 10% overcorrection
Measured: 20 weeks
Secondary outcomes (1)
safety of the UNFO-s device
Safety is defined as absence of serious complications associated with the use of the investigational device within 2 month of the last visit.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metatarsus AdductusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unfo Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Atar, Prof, Principal investigator, Soroka MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600183
- Sponsor's protocol ID
- UNFO-12-SOR-CTIL
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Universal Neonatal Foot Orthosis in the Treatment of Metatarsus Adductus (MTA)
- ClinicalTrials.gov ID
- NCT01600183
- Acronym / sponsor ID
- UNFO-12-SOR-CTIL
- Conditions
- Metatarsus Adductus, Metatarsus Varus
- Keywords
- MTA, metatarsus, Metatarsus Adductus, also known as Metatarsus Varus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Unfo Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 16 May 2012 (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.
This is a prospective, randomized, control, open label study in which up to 50 subjects with metatarsus adductus (MTA) will be enrolled. Subjects will be treated with the standard casting or using the UNFO-s device for total time of 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| casting | Active comparator | Procedure: castsubjects with MTA will be treated with cast for 20 weeks. casting is replaced during every study visit. |
| UNFO-s | Experimental | Device: UNFO-ssubjects with MTA will be treated with the UNFO-s device for 12 weeks - will be worn day and night during first 6 weeks and only at night during next 6 weeks |
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects with an acute MTA that did not receive any treatment for this condition
- Consenting parents
- Ages 1-4 months
Key exclusion criteria (3 listed)
- Participation in another clinical trial.
- Neuromuscular disorders
- Any condition which in the opinion of the investigator renders the subject ineligible for study participation.
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 |
|---|---|---|
| UNFO-sThe UNFO-s is a foot orthosis used to treat congenital foot malformations in infants | Device | UNFO-s |
| castcasting of the infant legs | Procedure or surgery | casting |
Primary outcome
Healing of the MTA
Time frame: 20 weeks
Healing of the MTA: straightening of the foot with apprx. 10% overcorrection
1 secondary outcome
safety of the UNFO-s device
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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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.
Dan Atar, Prof principal investigator
Soroka MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNFO-s and cast in people with Metatarsus Adductus and Metatarsus Varus, run by Unfo Ltd. 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 3 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 16 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Dan Atar, Prof (972-506264277, dan_atar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of the MTA (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2012.