NCT05381558

Brief Summary

  • Population: adolescent patients aged from 10 to 16 years
  • Interventions:
  • Examination under general anaesthesia if the deformity corrected spontaneously
  • local injection of steroid in sinus tarsi
  • cast in varus for 6 weeks
  • Outcomes: primary outcome : Evaluate the clinical and functional outcomes according AOFAS.
  • Time: follow up within one and half month, 3 months, 6 months, one year.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

May 15, 2022

Last Update Submit

May 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the functional outcomes according AOFAS Ankle-hindfoot scale

    45days

Study Arms (1)

spasmotic flatfoot patient

EXPERIMENTAL
Drug: Triamcinolone Injection

Interventions

local injection in sinus tarsi

spasmotic flatfoot patient

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age of the patients from 10 to 16 years
  • Flat foot with peroneal muscle spasm

You may not qualify if:

  • Flatfoot uncorrected by manipulation under general anaesthesia
  • neuromuscular disorders
  • evidence of coalition in CT or MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, Egypt

RECRUITING

Related Publications (5)

  • BLOCKEY NJ. Peroneal spastic flat foot. J Bone Joint Surg Br. 1955 May;37-B(2):191-202. doi: 10.1302/0301-620X.37B2.191. No abstract available.

    PMID: 14381462BACKGROUND
  • Jayakumar S, Cowell HR. Rigid flatfoot. Clin Orthop Relat Res. 1977 Jan-Feb;(122):77-84.

    PMID: 837623BACKGROUND
  • Harris EJ, Vanore JV, Thomas JL, Kravitz SR, Mendelson SA, Mendicino RW, Silvani SH, Gassen SC; Clinical Practice Guideline Pediatric Flatfoot Panel of the American College of Foot and Ankle Surgeons. Diagnosis and treatment of pediatric flatfoot. J Foot Ankle Surg. 2004 Nov-Dec;43(6):341-73. doi: 10.1053/j.jfas.2004.09.013. No abstract available.

    PMID: 15605048BACKGROUND
  • Luhmann SJ, Rich MM, Schoenecker PL. Painful idiopathic rigid flatfoot in children and adolescents. Foot Ankle Int. 2000 Jan;21(1):59-66. doi: 10.1177/107110070002100111.

    PMID: 10710264BACKGROUND
  • HARRIS RI, BEATH T. Etiology of peroneal spastic flat foot. J Bone Joint Surg Br. 1948 Nov;30B(4):624-34. No abstract available.

    PMID: 18894612BACKGROUND

MeSH Terms

Conditions

Flatfoot

Interventions

Triamcinolone

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)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

pemen philllip, bachelor

CONTACT

peter phillip, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

May 15, 2022

First Posted

May 19, 2022

Study Start

April 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations