NCT07449650

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Feb 2026

Typical duration for not_applicable

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

Study Progress37%
Feb 2026Dec 2027

Study Start

First participant enrolled

February 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2027

Last Updated

March 4, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

February 27, 2026

Last Update Submit

February 27, 2026

Conditions

Flexible Flatfoot or Pes Planus

Outcome Measures

Primary Outcomes (1)

  • Foot and ankle ability measure visual analogue scale radiological

    clinical and radiological

    1 year

Study Arms (2)

calcaneal lengthening osteotomy with locking wedge plate fixation

ACTIVE COMPARATOR

one group will undergo calcaneal lengthening osteotomy to lengthen lateral columan using locking wedge plate fixation to maintain lengthening

Procedure: calcaneal lengthening osteotomyProcedure: calcaneal lengthening osteotomy with locking wedge plate

calcaneal lengthening osteotomy with PEEK cage interposition

ACTIVE COMPARATOR

second group will undergo calcaneal lengthening osteotomy to lengthen lateral columan using PEEK cage interposition to maintain lengthening

Procedure: calcaneal lengthening osteotomyProcedure: calcaneal lengthening osteotomy with synthetic PEEK cage interposition

Interventions

calcaneal lengthening osteotomyPROCEDURE

calcaneal lengthening osteotomy is a surgical procedure to correct symptomatic flexible pes planovalgus foot deformity in adolescents

calcaneal lengthening osteotomy with PEEK cage interpositioncalcaneal lengthening osteotomy with locking wedge plate fixation
calcaneal lengthening osteotomy with locking wedge platePROCEDURE

one group will undergo calcaneal lengthening osteotomy with locking wedge plate fixation to maintain lengthening

calcaneal lengthening osteotomy with locking wedge plate fixation
calcaneal lengthening osteotomy with synthetic PEEK cage interpositionPROCEDURE

second group will undergo calcaneal lengthening osteotomy with PEEK cage interposition to maintain lengthening

calcaneal lengthening osteotomy with PEEK cage interposition

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • previous foot surgery
  • patients with neuromuscular disorders
  • patients with rigid pes Plano valgus
  • patients with sever comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, 82716, Egypt

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mohamed Elsayed Osman, specialist

CONTACT

020-01006254523mohamed_elsayed_post@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
orthopaedic specialist

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 4, 2027

Study Completion (Estimated)

December 4, 2027

Last Updated

March 4, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Locations

EG(1)