- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06957353
Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction
April 25, 2025 updated by: Mina S. Fekry, Assiut University
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
20
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
- Name: Mina Safwat Fekry, assistant lecturer
- Phone Number: 01280880281
- Email: MinaS.Fekry@aun.edu.eg
Study Contact Backup
- Name: Mohammed Mostafa Kotb, professor
Study Locations
-
-
-
Assiut, Egypt, 71515
- Assiut University Hospital
-
Contact:
- Alaa Abd El Monam
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- symptomatic flatfoot that will undergo flatfoot correction with calcaneal displacement osteotomy.
Exclusion Criteria:
- prior foot surgery
- Severe comorbidities or contradictions of the surgery
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction
oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of degree of desired displacement
Time Frame: baseline
|
Intra-operative assessment of degree of desired displacement clinical and radiological
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammed Mostafa Kotb, professir, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Brilhault 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.
- Mueller 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.
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)
May 1, 2025
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
April 21, 2025
First Submitted That Met QC Criteria
April 25, 2025
First Posted (Actual)
May 4, 2025
Study Record Updates
Last Update Posted (Actual)
May 4, 2025
Last Update Submitted That Met QC Criteria
April 25, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUH-Calcaneal_osteotomy-2025
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.
Clinical Trials on Flat Foot
-
Hacettepe UniversityEnrolling by invitationSpinal Curvatures | Flat Foot [Pes Planus] (Acquired), Left Foot | Flat Foot [Pes Planus] (Acquired), Right Foot | Flat Foot Acquired Bilateral (Pes Planus) | Pelvic ObliquityTurkey
-
Assiut UniversityUnknownFlat Foot; Rigid | Flat Foot; Spastic
-
Deraya UniversityCompleted
-
University of ExtremaduraCompleted
-
Shanghai University of Traditional Chinese MedicineCompletedFoot Function Index, Flat Foot, Dynamic Plantar Pressure, Reliability, ValidityChina
-
TOPMEDNatural Sciences and Engineering Research Council, Canada; Cryos Technologies...CompletedFlat Feet | High Arched FootCanada
-
Istituto Ortopedico RizzoliRecruitingFlat Feet | Subtalar Arthrorisis | Growth AgeItaly
-
Istituto Ortopedico RizzoliCompletedSurgery | Sports Physical Therapy | Flat FeetItaly
-
National Yang Ming UniversityTerminatedFlat Feet | Forefoot VarusTaiwan