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Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus

NCT05602844 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-09-25

No results posted yet for this study

Summary

RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.

Conditions

  • Hallux Valgus
  • Bunion
  • Patient Spe

Interventions

PROCEDURE

PSI Lapidus

Design of PSI: DICOM files will be imported into the Model Intestinal Microflora in Computer Simulation (MIMICS 21.0) 3D image processing software (Materialize, Belgium) for 3D rendering. The segmented bone images will be used for design of the computer-aided modelling (CAM) surgical jigs. 3D printing of PSI jig. PSI-assisted Lapidus Surgery.

PROCEDURE

Conventional Lapidus

exposure of the 1TMTJ via a 3-5cm medial longitudinal skin incision and capsulotomy. Freehand creation of the fusion surface with fluoroscopic assistance. Fixation of the Lapidus arthrodesis will be performed with two 3.5mm headless compression screws

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Samuel Ling · CUHK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05602844 on ClinicalTrials.gov