Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus
NCT ID: NCT05602844
Last Updated: 2023-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
54 participants
INTERVENTIONAL
2023-04-01
2025-12-31
Brief Summary
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Detailed Description
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Methods and analysis:
This is a single-blinded, parallel-group, randomised controlled trial comparing the outcome of the 3D-Printed PSI Assisted Lapidus Fusion (n=27) vs Conventional Lapidus Fusion (n=27) for HV deformity. Both groups will receive indentical post-operative rehabilitation of protected weight bearing and splinting. Outcomes measured will include foot function scores, radiological alignment and arthrodesis site assessment with X-ray and High-Resolution Peripheral Quantitative-Computed Tomography, and foot pressure analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PSI Lapidus
Design of PSI, 3D printing of PSI, PSI-assisted Lapidus Surgery.
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.
Conventional Lapidus
Lapidus Surgery: 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.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* hallux valgus angle \>20
* 1,2 Inter-metatarsal angle \>9
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Samuel KK Ling
Clinical Assistant Professor
Principal Investigators
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Samuel Ling
Role: PRINCIPAL_INVESTIGATOR
CUHK
Locations
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CUHK
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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HV PSI Lapidus
Identifier Type: -
Identifier Source: org_study_id
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