NCT06763523

Brief Summary

Arthroereisis ,corrective osteotomies, flexible pes planovalgus, adolescents

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 23, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

January 19, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1 day

First QC Date

December 23, 2024

Last Update Submit

January 1, 2025

Conditions

Pes Plano Valgus

Outcome Measures

Primary Outcomes (1)

  • AOFAS score

    American Orthopaedic Foot \& Ankle Society

    2 years from the start of the study

Secondary Outcomes (1)

  • VAS score

    2 years from the start of the study

Study Arms (2)

Group B

ACTIVE COMPARATOR

arthroereisis without corrective osteotomies

Procedure: arthroereisis of the subtalar joint

Group A

ACTIVE COMPARATOR

arthroereisis with corrective osteotomies

Procedure: arthroereisis of the subtalar joint

Interventions

arthroereisis of the subtalar jointPROCEDURE

arthroereisis alone versus arthroereisis combined with corrective osteotomies

Group AGroup B

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • neurological disorders and rigid peaplanovalgus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Egypt

Location

Central Study Contacts

Ahmed Mohieldien Abdelrahman, specialist

CONTACT

01060480320ahmed.elsayed2@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 8, 2025

Study Start

January 19, 2025

Primary Completion

January 20, 2025

Study Completion

January 20, 2026

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

EG(1)