NCT05602844

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

Randomised Controlled Trial Comparing the Outcome of the 3D-Printed Patient-Specific-Instrument Assisted Lapidus Fusion vs Conventional Lapidus Fusion for Surgical Correction of Hallux Valgus Deformity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Hallux valgus (HV) affects up to 30% of the population. Lapidus surgery, a combination of 1st tarsal-metatarsal joint arthrodesis is one of the most common surgical options for HV. Despite its popularity, the current method alone is not without complications. This will be the world's first Lapidus arthrodesis surgery utilising patient-specific instruments (PSI) as an assistive tool. We hypothesise that PSI will enhance surgical precision, accelerate fusion rates, decrease non-unions, and reduce the need to use bone grafts. 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

• Hallux Valgus
• Bunion
• Patient Spe

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-11-02
• Last updated: 2023-09-25

Locations

1 site across 1 country: Hong Kong