Total knee arthroplasty (TKA) is the gold standard for treatment of end-stage osteoarthritis. Previous studies have shown that successful outcomes following TKA depend on accurate implant alignment and soft tissue balancing. Robotic-assisted TKA have demonstrated improved accuracy in component placement and have been associated with better outcomes and patient satisfaction. This study aims to report on the execution accuracy of two generations of handheld robotic-assisted surgical systems.
This was a retrospective analysis of TKA procedures with two sequential generations of the same handheld robotic-assisted surgical system. Intra-operative data captured included pre-operative limb deformity, limb axes, range of motion, kinematic balance, and the resulting plan for component placement in three-dimensional space. Patients were stratified based on their preoperative coronal lower limb mechanical alignment (> 3° varus, < 3° varus, < 3° valgus, and ≥ 3° valgus). Measurements of component placement (overall lower limb alignment, medial and lateral flexion gaps, and tibial and femoral resection depths) were assessed using descriptive statistics.
A total of 435 patients were included and stratified based on preoperative lower limb alignment: 229 with ≥ 3° varus, 78 with varus < 3° and 58 with valgus < 3°, and 70 with valgus > 3°. The mean difference between planned and achieved alignment in the lower limb valgus patients was < 1° across all groups. Mean differences between planned and achieved medial flexion gap was higher in the > 3° subgroup in the varus patient cohort ([< 3°]: 1.15 ± 1.92 vs. [> 3°]: 1.90 ± 2.57); this value was higher in the < 3° subgroup for valgus patients ([< 3°]: 1.34 ± 1.83 vs. [> 3°]: 0.956 ± 1.65). Average resection depth ranged from 9.46 to 10.4 mm in the posterior medial femur, 9.25 to 9.95 mm in the posterior lateral femur, 7.45 to 8.79 mm in the distal medial femur, 8.22 to 9.18 mm in the distal lateral femur, 6.70 to 7.07 mm in the medial tibial condyle and 6.40 to 7.19 mm in the lateral tibial condyle. Non-inferiority testing demonstrated the newer generation is non-inferior to the older generation.
Robotic-assisted knee replacement using handheld image-free systems is able to maintain accuracy of component placement. Further investigation of patient reported outcomes as well as long-term implant longevity are needed.