NCT06957353

Brief Summary

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.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 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

First Submitted

Initial submission to the registry

April 21, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 21, 2025

Last Update Submit

April 25, 2025

Conditions

Keywords

flat footcalcaneal osteotomy

Outcome Measures

Primary Outcomes (1)

  • assessment of degree of desired displacement

    Intra-operative assessment of degree of desired displacement clinical and radiological

    baseline

Study Arms (1)

Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction

OTHER

oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction

Procedure: oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction

Interventions

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.

Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • symptomatic flatfoot that will undergo flatfoot correction with calcaneal displacement osteotomy.

You may not qualify if:

  • prior foot surgery
  • Severe comorbidities or contradictions of the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 39160476BACKGROUND
  • 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.

    PMID: 34687951BACKGROUND
  • 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.

    PMID: 38554203BACKGROUND

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

Study Officials

  • Mohammed Mostafa Kotb, professir

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina Safwat Fekry, assistant lecturer

CONTACT

Mohammed Mostafa Kotb, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: using an oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 4, 2025

Study Start

May 1, 2025

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations