Arthroereisis With Corrective Osteotomy Versus Arthroereisis Alone in Management of Symptomatic Flexible Pes Planovalgus in Adolescents

January 1, 2025 updated by: Ahmed Mohy Eldien Abdelrahman, Sohag University
Arthroereisis ,corrective osteotomies, flexible pes planovalgus, adolescents

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Locations

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

Yes

Description

Inclusion Criteria:

  • cases complaining of flexible pes planovalgus non responsive for conservative treatment and cases with generalized ligamentous laxity

Exclusion Criteria:

  • neurological disorders and rigid peaplanovalgus

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: Group B
arthroereisis without corrective osteotomies
Procedure: arthroereisis of the subtalar joint
arthroereisis alone versus arthroereisis combined with corrective osteotomies
Active Comparator: Group A
arthroereisis with corrective osteotomies
Procedure: arthroereisis of the subtalar joint
arthroereisis alone versus arthroereisis combined with corrective osteotomies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS score
Time Frame: 2 years from the start of the study
American Orthopaedic Foot & Ankle Society
2 years from the start of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: 2 years from the start of the study
visual analog score
2 years from the start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

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)

January 19, 2025

Primary Completion (Estimated)

January 20, 2025

Study Completion (Estimated)

January 20, 2026

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-24-12---1MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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