Functional and radiographic comparison of subtalar arthroereisis and lateral calcaneal lengthening in surgical treatment of flexible flatfoot in children
1- Determination and comparison of patients' mean pain score based on VAS 12 months after surgery
2- Determination and comparison of mean pain score of patients based on VAS scale before and 12 months after subtalar arthroereisis surgery
3- Determination and comparison of mean pain score of patients based on VAS scale before and 12 months after Lateral calcaneal lengthening surgery
4- Determination and Comparison of Frequency Distribution of Clinical Evaluation Indices Based on MOSCA Criterion 12 Months after Surgery in Patients in Two Groups
Design
A clinical trial with a parallel-group, the single-blind, block randomized, sample size of 25 patients
Settings and conduct
Surgery was performed at a Kashani hospital by a surgeon.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction , children with idiopathic symptomatic flat foot who were treated by arch support for at least 6 months of medical treatment.
Exclusion criteria: Patients with underlying diseases such as metabolic bone disease, CP, myelomeningocele, arthrogryposis, history of trauma, carcinoma and parathyroid gland disease.
Intervention groups
In this study, 25 children with a flexibly flat foot, 8-14 years old, from 2016 to 2017 are candidates for subtalar arthroereisis surgery and will be prospectively evaluated. These children were treated medically before surgery for subtalar arthroereisis and lateral calcaneal lengthening.
Main outcome variables
Signs of subtalar arthroereisis and lateral calcaneal lengthening
VAS criteria
Mosca criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180823040853N1
Registration date:2020-06-29, 1399/04/09
Registration timing:retrospective
Last update:2020-06-29, 1399/04/09
Update count:0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Mohammad Ali Tahririan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3972 6873
Email address
tahririan@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Functional and radiographic comparison of subtalar arthroereisis and lateral calcaneal lengthening in surgical treatment of flexible flatfoot in children
Public title
Functional and radiographic comparison of subtalar arthroereisis and lateral calcaneal lengthening in surgical treatment of flexible flatfoot in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study, Children with idiopathic symptomatic flat feet who have been supported by arch support for at least 6 months of medical treatment
Exclusion criteria:
underlying bone metabolic disease
cerebral palsy
myelomeningocele
arthrogryposis
parathyroid problems
Age
From 8 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization method was used and we use computer generated randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2019-12-22, 1398/10/01
Ethics committee reference number
IR.MUI.MED.REC.1398.415
Health conditions studied
1
Description of health condition studied
pediatric flexible flat foot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
Reduce and improve skeletal muscle pain
Timepoint
Medical treatment at 6 months before surgery and AP and lateral foot and ankle radiographs in standing position before and 12 months after surgery
Method of measurement
MOSCA, VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Twenty-five children with a flexible flat foot candidate for subtalar arthroereisis surgery will be enrolled in the study and will be prospectively evaluated. These children were treated medically before surgical treatment. All patients are supine and under general anesthesia. A 2cm incision is made in the lateral malleolus at the site of the anteroinferior, and the calcaneo-stop screw is then inserted into the heel bone at the entrance of the tarsus sinus to limit the movements of the talus. It is built to maintain the physiological and anatomical structure of the talus and calcaneus. Surgery will be performed at Kashani Hospital and all by a surgeon.
Category
Treatment - Surgery
2
Description
Twenty-five children with flexible flatfoot are candidates for Lateral calcaneal lengthening surgery. These children were treated medically before surgical treatment. All patients were supine and under general anesthesia. A 3 cm incision was made at the anterior third of the heel bone, and between the anterior and middle articular surface of the calcaneal osteotomy was performed, followed by an allograft at the osteotomy site.