NCT03749265

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

November 20, 2018

Last Update Submit

December 4, 2018

Conditions

Clubfoot

Keywords

Peroneus Tertius Muscle

Outcome Measures

Primary Outcomes (1)

  • Presence or Absence of peroneus tertius

    1 hour

Interventions

Ultrasound testOTHER

patients need to undergo an ultrasound test for detecting the presence or abscence of peroneus tertius tendon

Eligibility Criteria

Age5 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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 /

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Clubfoot

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Eytan Dujovni, senior

    haemek medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eytan Dujovni, senior

CONTACT

+97254761-1961eytan_du@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior doctor in orthopedics department

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 21, 2018

Study Start

December 1, 2018

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

December 5, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share