The NAVIO robotic-assisted TKA (RA-TKA) application received FDA clearance in May 2017. This semi-active robotic technique aims to improve the accuracy and precision of total knee arthroplasty. The addition of robotic-assisted technology, however, also introduces another potential source of surgery-related complications. This study evaluates the safety profile of NAVIO RA-TKA. Beginning in May 2017, the first 250 patients undergoing NAVIO RA-TKA were included in this study. All intra-operative complications were recorded, including: bleeding; neuro-vascular injury; peri-articular soft tissue injury; extensor mechanism complications; and intra-operative fracture. During the first 90 days following surgery, patients were monitored for any post-operative complications, including: superficial and deep surgical site infection; pin-tract infection; pin site fractures; peri-prosthetic fractures; axial or sagittal joint instability; axial mal-alignment; patello-femoral instability; DVT/PE; re-operation or re-admission due to surgical-related complications. Surgical technique and multi-modality pain management protocol was consistent for all patients in the study. A combined anesthetic technique was employed for all cases, including: low-dose spinal, adductor canal block and general anesthetic. Patients were mobilized per our institution's rapid recovery protocol.Introduction/Aim
Materials and Methods
Mid-flexion instability is a well-documented, but often poorly understood cause of failure of TKA. NAVIO robotic-assisted TKA (RA-TKA) offers a novel, integrative approach as a planning, execution as well as an evaluation tool in TKA surgery. RA-TKA provides a hybrid planning technique of measured resection and gap balancing- generating a predictive soft-tissue balance model, prior to making cuts. Concurrently, the system uses a semi-active robot to facilitate both the execution and verification of the plan, as it pertains to both the static and dynamic anatomy. The goal of this study was to assess the ability of the NAVIO RA-TKA to plan, execute and deliver an individualized approach to the soft-tissue balance of the knee, specifically in the “mid-flexion” arc of motion. Between May and September 2018, 50 patients underwent NAVIO RA-TKA. Baseline demographics were collected, including age, gender, BMI, and range of motion. The NAVIO imageless technique was used to plan the procedure, including: surface-mapping of the static anatomy; objective assessment of the dynamic, soft-tissue anatomy; and then application of a hybrid of measured-resection and gap-balancing technique. Medial and lateral gaps as predicted by the software were recorded throughout the entire arc of motion at 15° increments. After executing the plan and placing the components, actual medial and lateral gaps were recorded throughout the arc of motion.Introduction/Aim
Materials and Methods
Surgical outcome analysis has shifted from surgeon- to patient-reported outcome measures (PROM). High rates of dissatisfaction (13–20%) in PROM after TKA have persisted despite significant advances in pain-management, implant design and introduction of newer surgical techniques. The NAVIO robotic-assisted TKA (RA-TKA) was introduced in May 2017 as an integrative approach to planning, execution and evaluation in TKA surgery. The goal of this study was to assess differences PROM scores between conventional instrumented TKA (CI-TKA) and RA-TKA. Starting in December 2016, prospective data collection of PROM's was initiated in a single-surgeon total joint arthroplasty registry. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was collected for all patients pre-operatively, at three months and at one year post-operatively. In Group A, from December 2016 through May 2017, patients were treated with CI-TKA instrumentation. In Group B, from June 2017 through December 2018, surgery was performed with the NAVIO RA-TKA technique. The Journey II total knee prosthesis was used for all cases. Peri-operative management was consistent for all patients in both groups.Introduction
Methods
Semi-active robots can improve the accuracy and precision of total knee arthroplasty (TKA). The surgical efficiency of the recently introduced NAVIO robotic-assisted (RA-TKA) surgery was assessed in this study to define: (1) the time commitment for RA-TKA; (2) the learning curve for RA-TKA; and (3) to compare RA-TKA surgical time commitment to conventional, instrumented TKA (CI-TKA). Beginning in May 2017, the first 100 patients undergoing NAVIO RA-TKA were registered pre-operatively. Operative time, defined as the time from surgical skin incision to capsular closure, was recorded. Exclusion criteria were cases in which surgical time was not recorded. During the same study period, surgical case times for fifty cases of CI-TKA procedures were also assessed. Baseline data, including age, gender, BMI, range of motion, was recorded for all subjects. Surgical and anesthetic technique, multi-modality pain management protocol, and post-operative mobilization was consistent for all patients enrolled in the study.Introduction
Materials and Methods
The JOURNEY™ II Cruciate-Retaining Total Knee System (JIICR) and the JOURNEY™ II Bi-Cruciate Stabilized Total Knee System (JIIBCS) (both, Smith & Nephew, Memphis, TN, USA) are used for the treatment of end-stage degenerative knee arthritis. Belonging to the JOURNEY family of knee implants, the relatively new devices are designed to provide guided motion. Studies suggest that long-term outcomes of robotic-assisted navigation in total knee arthroplasty (TKA) are superior to the classical approach. This is the first report describing early postoperative outcomes of the NAVIO® robotic-assisted surgical navigation using the JOURNEY™ II family of knee implants. In this ongoing study, six investigational sites in the US prospectively enrolled 122 patients (122 TKAs, 64 JIIBCS and 58 JIICR). Patients underwent TKA using the NAVIO system (Figure 1), a next-generation semi-autonomous tool that uses handheld miniaturized robotic-assisted instrumentation that the surgeon manipulates in 6 degrees of freedom, but restricts cutting to within the confines of the pre-designated resection area of the patient's bone. The primary outcome was postoperative mechanical alignment on long leg X-ray at one month postoperative compared to operative target alignment. Alignment within ±3 degrees of the target alignment was considered a success.Background
Materials & Methods
