- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449650
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
February 27, 2026 updated by: Mohamed Elsayed Othman
The goal of this interventional study is to compare clinical outcome, radiological parameters, complication rates and time to recovery of calcaneal lengthening osteotomy with locking wedge plate versus PEEK cage interposition in management of symptomatic flexible pes planovalgus foot deformity in adolescents
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Elsayed Osman, specialist
- Phone Number: 020-01006254523
- Email: mohamed_elsayed_post@med.sohag.edu.eg
Study Locations
-
-
-
Sohag, Egypt, 82716
- Sohag faculty of medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients with symptomatic flexible pes planovalgus indicated for surgical correction
- age: from 10 years to 17 years
- sex: males and females
- failure of conservative management
Exclusion Criteria:
- previous foot surgery
- patients with neuromuscular disorders
- patients with rigid pes Plano valgus
- patients with sever comorbidities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: calcaneal lengthening osteotomy with locking wedge plate fixation
one group will undergo calcaneal lengthening osteotomy to lengthen lateral columan using locking wedge plate fixation to maintain lengthening
|
calcaneal lengthening osteotomy is a surgical procedure to correct symptomatic flexible pes planovalgus foot deformity in adolescents
one group will undergo calcaneal lengthening osteotomy with locking wedge plate fixation to maintain lengthening
|
|
Active Comparator: calcaneal lengthening osteotomy with PEEK cage interposition
second group will undergo calcaneal lengthening osteotomy to lengthen lateral columan using PEEK cage interposition to maintain lengthening
|
calcaneal lengthening osteotomy is a surgical procedure to correct symptomatic flexible pes planovalgus foot deformity in adolescents
second group will undergo calcaneal lengthening osteotomy with PEEK cage interposition to maintain lengthening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot and ankle ability measure visual analogue scale radiological
Time Frame: 1 year
|
clinical and radiological
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
December 4, 2027
Study Completion (Estimated)
December 4, 2027
Study Registration Dates
First Submitted
February 27, 2026
First Submitted That Met QC Criteria
February 27, 2026
First Posted (Actual)
March 4, 2026
Study Record Updates
Last Update Posted (Actual)
March 4, 2026
Last Update Submitted That Met QC Criteria
February 27, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Flatfoot
Other Study ID Numbers
- Soh-Med-26-1-4MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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