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

Introduction Hallux 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 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 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 Limitations ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ClinicalTrials.gov Identifier: [NCT05602844][1] ### Funding Statement Yes ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Joint CUHK-NTEC CREC Ref 2020.633-T has granted ethics approval for this proposed study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05602844&atom=%2Fmedrxiv%2Fearly%2F2023%2F10%2F05%2F2023.10.05.23296589.atom