New Robotic Knee Surgery: does Implant Type Affect Alignment Accuracy?

This is a single‐center, prospective, double‐blinded, randomized controlled trial (RCT)conducted at the Department of Orthopaedics & Traumatology, The Duchess of KentChildren's Hospital (DKCH), Hong Kong. The study aims to evaluate the accuracy ofpostoperative knee alignment relative to preoperative planning when using two differentcommercially available total knee arthroplasty (TKA) implant systems (Attune and Persona)in conjunction with a novel CT‐based robotic surgical system (KUNWU® Robotic SurgicalSystem, Yuanhua Robotics, Perception & AI Technologies Limited, Hong Kong).Randomization and Blinding Eligible participants will be randomized in a 1:1 ratio toreceive either the Attune or Persona implant using a computer‐generated randomizationsequence. Allocation concealment will be maintained using sequentially numbered, opaque,sealed envelopes. The study is double‐blinded: participants and outcome assessors will beblinded to implant allocation. The operating surgeon cannot be blinded due to theinherent differences in implant instrumentation and design.Surgical Procedure All surgeries will be performed by a single surgical team using theKUNWU® robotic system. Preoperative planning will be based on CT‐derived 3D models of thepatient's knee joint, allowing for individualized determination of implant size,positioning, and alignment targets. Intraoperatively, the robotic system providesreal‐time haptic feedback and bone resection guidance to execute the preoperative plan.The choice of implant (Attune or Persona) is the only variable; all other aspects of thesurgical procedure, including approach, soft tissue balancing, and postoperativerehabilitation protocol, will be standardized across both groups.Assessments and Follow‐up Schedule Participants will undergo a series of clinical andradiological assessments at specified time points throughout the study.Imaging Assessments:Computed Tomography (CT) scans will be performed preoperatively and once postoperativelyto assess knee alignment.Standard X‐rays will be taken preoperatively, and at 3 months, 6 months, 12 months, and24 months postoperatively.Clinical Assessments:All clinical outcome assessments will be administered by a blinded assessor. Assessmentswill take place preoperatively, and at 6 weeks, 3 months, 6 months, 12 months, and 24months postoperatively. The following validated instruments will be used:Pain Assessment: Visual Analog Scale (VAS) for painFunctional Assessment: Forgotten Joint Score (FJS) and Knee Injury and OsteoarthritisOutcome Score, Junior (KOOS, JR)Quality of Life Assessment: Short‐Form‐12 (SF‐12) health surveySafety Monitoring:All intraoperative and postoperative complications, including but not limited toinfection, dislocation, and need for revision surgery, will be documented throughout thefollow‐up period. Length of hospital stay and cost‐effectiveness data will also becollected.Summary of Assessment Schedule:In summary, CT scans are performed twice (preoperatively and postoperatively), whileX‐rays are performed at five time points (preoperatively, 3 months, 6 months, 12 months,and 24 months). Clinical outcome assessments using VAS, FJS, KOOS, JR, and SF‐12 areconducted at six time points (preoperatively, 6 weeks, 3 months, 6 months, 12 months, and24 months). Complications are monitored at all postoperative visits from 6 weeks through24 months.