Rate Of Residual Clubfoot Deformity With Correlation To A... | NCT03749265

Studies
Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle

NCT03749265

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Dec 5, 2018Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Clubfoot

Interventions

Ultrasound test

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2018Estimated

Primary Completion Date

Aug 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Nov 20, 2018

First Submission Date that Met QC Criteria

Nov 20, 2018

First Posted Date

Nov 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2018

Last Update Posted Date

Dec 5, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eytan Dujovny, Senior doctor in orthopedics department, HaEmek Medical Center, IsraelPrincipal Investigator

Lead Sponsor

HaEmek Medical Center, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle , A Prospective Study.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound test	Other	patients need to undergo an ultrasound test for detecting the presence or abscence of peroneus tertius tendon

Measure	Description	Time Frame
Presence or Absence of peroneus tertius		1 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 /

Exclusion Criteria:

patients aged< 5 years
Neurological Clubfoot
patients with insufficient data in medical records
clubfoot caused by arthrogryposis , connective tissue diseases and congenital fibular hemimelia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder 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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eytan Dujovni, senior	Contact	+97254761-1961		eytan_du@clalit.org.il

Overall Officials

Name	Affiliation	Role
Eytan Dujovni, senior	haemek medical center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003025	Clubfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation

Browse Leaves

Not provided

Browse Branches

Not provided