Research Protocol for a 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

Abstract

IntroductionHallux valgus (HV) affects up to 30% of the population. Lapidus surgery with 1st tarsal-metatarsal joint arthrodesis is one of the most common surgical options for HV. Despite its popularity, the current procedure is not without complications. This investigation will be the world’s first Lapidus arthrodesis surgery utilising patient-specific instruments (PSI) as an assistive tool. We hypothesise that the PSI will enhance surgical precision, accelerate fusion rates, decrease non-unions, and reduce the need to use bone grafts.Methods and analysisThis 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 an identical postoperative rehabilitation of protected weight bearing and splinting. Outcomes 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.Strengths and LimitationsStrengthsThis will be the world’s first randomised control trial utilising PSI for hallux valgus surgery.Surgeries are done by a team of experienced foot and ankle surgeons.LimitationsA single-centre study with a follow-up of only 1 year. However, the authors believe that traditional Lapidus surgery has known term results, and the chief hypothetical benefit of PSI-assisted surgery is faster bony fusion and less surgical complications, which will be evident within 1 year.