Flexible Flatfoot or Pes PlanusNCT07449650
Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
A study testing calcaneal lengthening osteotomy, calcaneal lengthening osteotomy with locking wedge plate and calcaneal lengthening osteotomy with synthetic PEEK cage interposition in people with Flexible Flatfoot or Pes Planus, run by Mohamed Elsayed Othman at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Flexible Flatfoot or Pes Planus
- What is being tested?
- calcaneal lengthening osteotomy, calcaneal lengthening osteotomy with locking wedge plate and calcaneal lengthening osteotomy with synthetic PEEK cage interposition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2026to 4 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- previous foot surgery
- patients with neuromuscular disorders
- patients with rigid pes Plano valgus
- patients with sever comorbidities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Conditions
- Flexible Flatfoot or Pes Planus
- Being tested
- calcaneal lengthening osteotomy, calcaneal lengthening osteotomy with locking wedge plate, calcaneal lengthening osteotomy with synthetic PEEK cage interposition
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcaneal lengthening osteotomyProcedure or surgery
calcaneal lengthening osteotomy is a surgical procedure to correct symptomatic flexible pes planovalgus foot deformity in adolescents
calcaneal lengthening osteotomy with locking wedge plateProcedure or surgery
one group will undergo calcaneal lengthening osteotomy with locking wedge plate fixation to maintain lengthening
calcaneal lengthening osteotomy with synthetic PEEK cage interpositionProcedure or surgery
second group will undergo calcaneal lengthening osteotomy with PEEK cage interposition to maintain lengthening
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: calcaneal lengthening osteotomy; Procedure: 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 Receives: Procedure: calcaneal lengthening osteotomy; Procedure: calcaneal lengthening osteotomy with synthetic PEEK cage interposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and ankle ability measure visual analogue scale radiological
clinical and radiological
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completion4 Dec 2027 (estimated)
- Study completion4 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible Flatfoot or Pes PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Elsayed Othman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Elsayed Othman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449650
- Sponsor's protocol ID
- Soh-Med-26-1-4MD
- Status last verified
- Dec 2025
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcaneal Lengthening Osteotomy With Locking Wedge Plate Versus Synthetic PEEK Cage Interposition for Symptomatic Flexible Pes Planovalgus Foot Deformity in Adolescents
- ClinicalTrials.gov ID
- NCT07449650
- Acronym / sponsor ID
- Soh-Med-26-1-4MD
- Conditions
- Flexible Flatfoot or Pes Planus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mohamed Elsayed OthmanUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- 4 Dec 2027 (estimated)
- Study completion
- 4 Dec 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcaneal lengthening osteotomy with locking wedge plate fixation | Active comparator | Procedure: calcaneal lengthening osteotomy, Procedure: calcaneal lengthening osteotomy with locking wedge plateone group will undergo calcaneal lengthening osteotomy to lengthen lateral columan using locking wedge plate fixation to maintain lengthening |
| calcaneal lengthening osteotomy with PEEK cage interposition | Active comparator | Procedure: calcaneal lengthening osteotomy, Procedure: calcaneal lengthening osteotomy with synthetic PEEK cage interpositionsecond group will undergo calcaneal lengthening osteotomy to lengthen lateral columan using PEEK cage interposition to maintain lengthening |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- previous foot surgery
- patients with neuromuscular disorders
- patients with rigid pes Plano valgus
- patients with sever comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcaneal lengthening osteotomycalcaneal lengthening osteotomy is a surgical procedure to correct symptomatic flexible pes planovalgus foot deformity in adolescents | Procedure or surgery | calcaneal lengthening osteotomy with PEEK cage interposition, calcaneal lengthening osteotomy with locking wedge plate fixation |
| calcaneal lengthening osteotomy with locking wedge plateone group will undergo calcaneal lengthening osteotomy with locking wedge plate fixation to maintain lengthening | Procedure or surgery | calcaneal lengthening osteotomy with locking wedge plate fixation |
| calcaneal lengthening osteotomy with synthetic PEEK cage interpositionsecond group will undergo calcaneal lengthening osteotomy with PEEK cage interposition to maintain lengthening | Procedure or surgery | calcaneal lengthening osteotomy with PEEK cage interposition |
Primary outcome
Foot and ankle ability measure visual analogue scale radiological
Time frame: 1 year
clinical and radiological
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcaneal lengthening osteotomy, calcaneal lengthening osteotomy with locking wedge plate and calcaneal lengthening osteotomy with synthetic PEEK cage interposition in people with Flexible Flatfoot or Pes Planus, run by Mohamed Elsayed Othman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Elsayed Osman, specialist (020-01006254523, mohamed_elsayed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and ankle ability measure visual analogue scale radiological (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.