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

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

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.

Inclusion Criteria:

• Symptomatic Hallux Valgus
• hallux valgus angle >20
• 1,2 Inter-metatarsal angle >9

Exclusion Criteria:

Individuals with (1) disabilities (both physical and mental) which may impair the adherence of the rehabilitation, (2) revision HV surgery, (3) concomitantly undergone additional procedures on the same foot (e.g. claw toe surgery), (4) the use of medications that may influence bone turnover (e.g. chemotherapy, osteoporotic medications) in recent 3 months, (5) medical comorbidity leading to contraindication for surgery, (6) the inability to understand written Chinese/English, (7) who are mentally/physically unable to consent will be excluded.