Flat FootNCT06957353
Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction
A study of Flat Foot, run by Assiut University at 1 site in Egypt.
Trial summary
Adult-acquired flatfoot deformity (AAFD) often requires surgical correction when conservative methods fail. Calcaneal displacement osteotomy is a key procedure in restoring alignment. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Flat Foot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 30 Dec 2025
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- symptomatic flatfoot that will undergo flatfoot correction with calcaneal displacement osteotomy.
Who cannot join
- prior foot surgery
- Severe comorbidities or contradictions of the surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed Mostafa Kotb, professor contact
About this study
Official title: Oblique Sliding K-wire Technique For Controlling Calcaneal Displacement Osteotomy In Flat Foot Correction
Adult-acquired flatfoot deformity (AAFD) often requires surgical correction when conservative methods fail. Calcaneal displacement osteotomy is a key procedure in restoring alignment. This study introduces a novel K-wire technique to enhance control during surgery and minimize complications related to manual manipulation. It builds on prior research highlighting the limitations of traditional approaches in achieving precise fragment positioning.
Read the detailed description
Flat foot deformity, particularly adult - acquired flatfoot (AAFD), often necessitates surgical intervention when conservative treatment fail. Calcaneal displacement osteotomy is a common surgical procedure for correcting calcaneal displacement and achieving stable fixation. The proposed K-wire technique offers a novel approach to improve control and reduce complications associated with manual manipulation during surgery. Previous studies have indicated challenges with traditional methods in achieving precise fragment control. This study aims to address these gaps.
- Conditions
- Flat Foot
- Being tested
- oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction
- Keywords
- flat foot, calcaneal osteotomy
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correctionProcedure or surgery
Under spinal Anaesthesia , patients will placed in lateral decubitus position. A standard lateral incision will be made over the calcaneus, and the osteotomy site will be exposed. An oblique K-wire will be inserted percutaneously into the posterior calcaneus under fluoroscopic guidance to facilitate the desired displacement. Cannulated screws will then be inserted across the osteotomy site to secure the calcaneal fragment. Post-operative care will include a non-weight bearing protocol for six weeks, followed by gradual weight bearing as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction | Other | oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction Receives: Procedure: oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of degree of desired displacement
Intra-operative assessment of degree of desired displacement clinical and radiological
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Flat FootStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- using an oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina S. Fekry, Assiut University
- Investigators
- Mohammed Mostafa Kotb, professir, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957353
- Sponsor's protocol ID
- AUH-Calcaneal_osteotomy-2025
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cai Y, Zhao Z, Huang J, Yu Z, Jiang M, Kang S, Yuan X, Liu Y, Wu X, Ouyang J, Li W, Qian L. Morphological changes in flatfoot: a 3D analysis using weight-bearing CT scans. BMC Med Imaging. 2024 Aug 19;24(1):219. doi: 10.1186/s12880-024-01396-0.
PubMed 39160476Brilhault J. Calcaneal osteotomy for hindfoot deformity. Orthop Traumatol Surg Res. 2022 Feb;108(1S):103121. doi: 10.1016/j.otsr.2021.103121. Epub 2021 Oct 20.
PubMed 34687951Mueller G, Frosch KH, Barg A, Schlickewei C, Weel H, Krahenbuhl N, Priemel M, Mueller E. Impact of the medial displacement calcaneal osteotomy on foot biomechanics: a systematic literature review. Arch Orthop Trauma Surg. 2024 May;144(5):1955-1967. doi: 10.1007/s00402-024-05267-9. Epub 2024 Mar 30.
PubMed 38554203
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oblique Sliding K-wire Technique For Controlling Calcaneal Displacement Osteotomy In Flat Foot Correction
- ClinicalTrials.gov ID
- NCT06957353
- Acronym / sponsor ID
- AUH-Calcaneal_osteotomy-2025
- Conditions
- Flat Foot
- Keywords
- flat foot, calcaneal osteotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 May 2025 (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.
Adult-acquired flatfoot deformity (AAFD) often requires surgical correction when conservative methods fail. Calcaneal displacement osteotomy is a key procedure in restoring alignment. This study introduces a novel K-wire technique to enhance control during surgery and minimize complications related to manual manipulation. It builds on prior research highlighting the limitations of traditional approaches in achieving precise fragment positioning.
Detailed description
Flat foot deformity, particularly adult - acquired flatfoot (AAFD), often necessitates surgical intervention when conservative treatment fail. Calcaneal displacement osteotomy is a common surgical procedure for correcting calcaneal displacement and achieving stable fixation. The proposed K-wire technique offers a novel approach to improve control and reduce complications associated with manual manipulation during surgery. Previous studies have indicated challenges with traditional methods in achieving precise fragment control. This study aims to address these gaps.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- using an oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction
| Arm | Type | Receives |
|---|---|---|
| Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction | Other | Procedure: oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correctionoblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- symptomatic flatfoot that will undergo flatfoot correction with calcaneal displacement osteotomy.
Key exclusion criteria (2 listed)
- prior foot surgery
- Severe comorbidities or contradictions of the surgery
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 |
|---|---|---|
| oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correctionUnder spinal Anaesthesia , patients will placed in lateral decubitus position. A standard lateral incision will be made over the calcaneus, and the osteotomy site will be exposed. An oblique K-wire will be inserted percutaneously into the posterior calcaneus under fluoroscopic guidance to facilitate the desired displacement. Cannulated screws will then be inserted across the osteotomy site to secure the calcaneal fragment. Post-operative care will include a non-weight bearing protocol for six weeks, followed by gradual weight bearing as tolerated. | Procedure or surgery | Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction |
Primary outcome
assessment of degree of desired displacement
Time frame: baseline
Intra-operative assessment of degree of desired displacement 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 May 2025.
- Background: PubMed 39160476Cai Y, Zhao Z, Huang J, Yu Z, Jiang M, Kang S, Yuan X, Liu Y, Wu X, Ouyang J, Li W, Qian L. Morphological changes in flatfoot: a 3D analysis using weight-bearing CT scans. BMC Med Imaging. 2024 Aug 19;24(1):219. doi: 10.1186/s12880-024-01396-0.
- Background: PubMed 34687951Brilhault J. Calcaneal osteotomy for hindfoot deformity. Orthop Traumatol Surg Res. 2022 Feb;108(1S):103121. doi: 10.1016/j.otsr.2021.103121. Epub 2021 Oct 20.
- Background: PubMed 38554203Mueller G, Frosch KH, Barg A, Schlickewei C, Weel H, Krahenbuhl N, Priemel M, Mueller E. Impact of the medial displacement calcaneal osteotomy on foot biomechanics: a systematic literature review. Arch Orthop Trauma Surg. 2024 May;144(5):1955-1967. doi: 10.1007/s00402-024-05267-9. Epub 2024 Mar 30.
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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.
Mohammed Mostafa Kotb, professor contact
Mohammed Mostafa Kotb, professir principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Flat Foot, run by Assiut University 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 1 inclusion and 2 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 May 2025. 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 Mina Safwat Fekry, assistant lecturer (01280880281, MinaS.Fekry@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of degree of desired displacement (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06957353, which also lists 3 linked publications.
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 May 2025.