ClubfootNCT03749265
Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle
An observational study of Clubfoot, run by HaEmek Medical Center, Israel.
Trial summary
Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle , A Prospective Study. Read more about this study
- Who is it for?
- Ages 5 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Clubfoot
- What is being tested?
- Ultrasound test
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Oct 2019
- Phase
- Observational
- 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 5 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients aged 5-17 years , which were treated with the Ponseti technique for Clubfoot in HaEmek medical center, and have sufficient data/follow-up about them in medical records
Who may be able to join
- patients aged 5-17 years , which were treated with the Ponseti technique for Clubfoot in HaEmek medical center, and have sufficient data/follow-up about them in medical records /
Who cannot join
- patients aged< 5 years
- Neurological Clubfoot
- patients with insufficient data in medical records
- clubfoot caused by arthrogryposis , connective tissue diseases and congenital fibular hemimelia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle: A Prospective Study
Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle , A Prospective Study.
- Conditions
- Clubfoot
- Being tested
- Ultrasound test
- Keywords
- Peroneus Tertius Muscle
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound testOther
patients need to undergo an ultrasound test for detecting the presence or abscence of peroneus tertius tendon
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or Absence of peroneus tertius
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eytan Dujovny, HaEmek Medical Center, Israel
- Investigators
- Eytan Dujovni, senior, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749265
- Sponsor's protocol ID
- EMC-0010-18
- Status last verified
- Dec 2018
- First submitted
- 20 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle: A Prospective Study
- ClinicalTrials.gov ID
- NCT03749265
- Acronym / sponsor ID
- EMC-0010-18
- Conditions
- Clubfoot
- Keywords
- Peroneus Tertius Muscle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 21 Nov 2018 (actual)
- 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.
Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle , A Prospective Study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 5-17 years , which were treated with the Ponseti technique for Clubfoot in HaEmek medical center, and have sufficient data/follow-up about them in medical records
Key inclusion criteria (1 listed)
- patients aged 5-17 years , which were treated with the Ponseti technique for Clubfoot in HaEmek medical center, and have sufficient data/follow-up about them in medical records /
Key exclusion criteria (4 listed)
- patients aged< 5 years
- Neurological Clubfoot
- patients with insufficient data in medical records
- clubfoot caused by arthrogryposis , connective tissue diseases and congenital fibular hemimelia
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 |
|---|---|---|
| Ultrasound testpatients need to undergo an ultrasound test for detecting the presence or abscence of peroneus tertius tendon | Other | – |
Primary outcome
Presence or Absence of peroneus tertius
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Eytan Dujovni, senior principal investigator
haemek medical center
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by HaEmek Medical Center, 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 1 inclusion and 4 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 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Eytan Dujovni, senior (+97254761-1961, eytan_du@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or Absence of peroneus tertius (time frame: 1 hour). 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 5 Dec 2018.