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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05381558
Other study ID # Spasmodic faltfoot
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date September 2022

Study information

Verified date May 2022
Source Assiut University
Contact pemen philllip, bachelor
Phone 01019944221
Email pemen.phillip@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- Population: adolescent patients aged from 10 to 16 years - Interventions: 1. Examination under general anaesthesia if the deformity corrected spontaneously 2. local injection of steroid in sinus tarsi 3. 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.


Description:

• Does local steroid injection have a role in treatment of spasmodic flat foot in adolescent patients? One of the most common foot complaints in the juvenile and adolescent age group is the "flatfoot" deformity. (1) Clinical evaluation of flatfeet primarily focuses on differentiation between the two main types: flexible and rigid. (2) The flexible type is a common diagnosis and is one which is usually not problematic and rarely needs treatment. (3) Rigid flatfoot deformity is less common (occurring one-third as often as the flexible type) but often is symptomatic and requires treatment. (4) Spasmodic valgus foot is usually associated with resistant pain and deformity. It shows controversy regarding its incidence, etiology, and treatment. (5) Spasmodic flatfoot is a rare condition characterized by a rigid and usually painful valgus deformity in the hind foot with peroneal muscles spasms (6,7) It is often caused by inter-tarsal bars or bone anomalies that restrict tarsal joint motion . (8) Our study aims to evaluate the functional and clinical outcome after local long-acting steroid injection in the sinus tarsi followed by cast in adolescent patients with spasmodic flatfeet without coalition.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 16 Years
Eligibility Inclusion Criteria: - Age of the patients from 10 to 16 years - Flat foot with peroneal muscle spasm Exclusion Criteria: - Flatfoot uncorrected by manipulation under general anaesthesia - neuromuscular disorders - evidence of coalition in CT or MRI

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone Injection
local injection in sinus tarsi

Locations

Country Name City State
Egypt Faculty of Medicine Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

BLOCKEY NJ. Peroneal spastic flat foot. J Bone Joint Surg Br. 1955 May;37-B(2):191-202. — View Citation

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. Review. — View Citation

HARRIS RI, BEATH T. Etiology of peroneal spastic flat foot. J Bone Joint Surg Br. 1948 Nov;30B(4):624-34. — View Citation

Jayakumar S, Cowell HR. Rigid flatfoot. Clin Orthop Relat Res. 1977 Jan-Feb;(122):77-84. — View Citation

Luhmann SJ, Rich MM, Schoenecker PL. Painful idiopathic rigid flatfoot in children and adolescents. Foot Ankle Int. 2000 Jan;21(1):59-66. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the functional outcomes according AOFAS Ankle-hindfoot scale 45days
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