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Bone & Joint Open
Vol. 3, Issue 5 | Pages 383 - 389
1 May 2022
Motesharei A Batailler C De Massari D Vincent G Chen AF Lustig S

Aims. No predictive model has been published to forecast operating time for total knee arthroplasty (TKA). The aims of this study were to design and validate a predictive model to estimate operating time for robotic-assisted TKA based on demographic data, and evaluate the added predictive power of CT scan-based predictors and their impact on the accuracy of the predictive model. Methods. A retrospective study was conducted on 1,061 TKAs performed from January 2016 to December 2019 with an image-based robotic-assisted system. Demographic data included age, sex, height, and weight. The femoral and tibial mechanical axis and the osteophyte volume were calculated from CT scans. These inputs were used to develop a predictive model aimed to predict operating time based on demographic data only, and demographic and 3D patient anatomy data. Results. The key factors for predicting operating time were the surgeon and patient weight, followed by 12 anatomical parameters derived from CT scans. The predictive model based only on demographic data showed that 90% of predictions were within 15 minutes of actual operating time, with 73% within ten minutes. The predictive model including demographic data and CT scans showed that 94% of predictions were within 15 minutes of actual operating time and 88% within ten minutes. Conclusion. The primary factors for predicting robotic-assisted TKA operating time were surgeon, patient weight, and osteophyte volume. This study demonstrates that incorporating 3D patient-specific data can improve operating time predictions models, which may lead to improved operating room planning and efficiency. Cite this article: Bone Jt Open 2022;3(5):383–389


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_8 | Pages 6 - 6
10 May 2024
Zaidi F Bolam S Goplen C Yeung T Lovatt M Hanlon M Munro J Besier T Monk A
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Introduction. Robotic-assisted total knee arthroplasty (TKA) has demonstrated significant benefits, including improved accuracy of component positioning compared to conventional jig-based TKA. However, previous studies have often failed to associate these findings with clinically significant improvements in patient-reported outcome measures (PROMs). Inertial measurement units (IMUs) provide a more nuanced assessment of a patient's functional recovery after TKA. This study aims to compare outcomes of patients undergoing robotic-assisted and conventional TKA in the early postoperative period using conventional PROMS and wearable sensors. Method. 100 patients with symptomatic end-stage knee osteoarthritis undergoing primary TKA were included in this study (44 robotic-assisted TKA and 56 conventional TKA). Functional outcomes were assessed using ankle-worn IMUs and PROMs. IMU- based outcomes included impact load, impact asymmetry, maximum knee flexion angle, and bone stimulus. PROMs, including Oxford Knee Score (OKS), EuroQol-Five Dimension (EQ-5D-5L), EuroQol Visual Analogue Scale (EQ-VAS), and Forgotten Joint Score (FJS-12) were evaluated at preoperative baseline, weeks 2 to 6 postoperatively, and at 3-month postoperative follow-up. Results. By postoperative week 6, when compared to conventional TKA, robotic-assisted TKA was associated with significant improvements in maximum knee flexion angle (118o ± 6.6 vs. 113o ± 5.4; p=0.04), symmetrical loading of limbs (82.3% vs.22.4%; p<0.01), cumulative impact load (146.6% vs 37%; p<0.01), and bone stimulus (25.1% vs 13.6%; p<0.01). Whilst there were no significant differences in PROMs (OKS, EQ-5D-5L, EQ-VAS, and FJS-12) at any time point between the two groups, when comparing OKS subscales, significantly more robotic-assisted TKA patients achieved an ‘excellent’ outcome at 6 weeks compared to conventional (47% vs 41%, p= 0.013). Conclusions. IMU-based metrics detected an earlier return to function among patients that underwent robotic-assisted TKA compared to conventional TKA that PROMs were unable to detect within the first six weeks of surgery


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 74 - 80
1 Jun 2021
Deckey DG Rosenow CS Verhey JT Brinkman JC Mayfield CK Clarke HD Bingham JS

Aims. Robotic-assisted total knee arthroplasty (RA-TKA) is theoretically more accurate for component positioning than TKA performed with mechanical instruments (M-TKA). Furthermore, the ability to incorporate soft-tissue laxity data into the plan prior to bone resection should reduce variability between the planned polyethylene thickness and the final implanted polyethylene. The purpose of this study was to compare accuracy to plan for component positioning and precision, as demonstrated by deviation from plan for polyethylene insert thickness in measured-resection RA-TKA versus M-TKA. Methods. A total of 220 consecutive primary TKAs between May 2016 and November 2018, performed by a single surgeon, were reviewed. Planned coronal plane component alignment and overall limb alignment were all 0° to the mechanical axis; tibial posterior slope was 2°; and polyethylene thickness was 9 mm. For RA-TKA, individual component position was adjusted to assist gap-balancing but planned coronal plane alignment for the femoral and tibial components and overall limb alignment remained 0 ± 3°; planned tibial posterior slope was 1.5°. Mean deviations from plan for each parameter were compared between groups for positioning and size and outliers were assessed. Results. In all, 103 M-TKAs and 96 RA-TKAs were included. In RA-TKA versus M-TKA, respectively: mean femoral positioning (0.9° (SD 1.2°) vs 1.7° (SD 1.1°)), mean tibial positioning (0.3° (SD 0.9°) vs 1.3° (SD 1.0°)), mean posterior tibial slope (-0.3° (SD 1.3°) vs 1.7° (SD 1.1°)), and mean mechanical axis limb alignment (1.0° (SD 1.7°) vs 2.7° (SD 1.9°)) all deviated significantly less from the plan (all p < 0.001); significantly fewer knees required a distal femoral recut (10 (10%) vs 22 (22%), p = 0.033); and deviation from planned polyethylene thickness was significantly less (1.4 mm (SD 1.6) vs 2.7 mm (SD 2.2), p < 0.001). Conclusion. RA-TKA is significantly more accurate and precise in planning both component positioning and final polyethylene insert thickness. Future studies should investigate whether this increased accuracy and precision has an impact on clinical outcomes. The greater accuracy and reproducibility of RA-TKA may be important as precise new goals for component positioning are developed and can be further individualized to the patient. Cite this article: Bone Joint J 2021;103-B(6 Supple A):74–80


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 59 - 59
1 Feb 2017
Keggi J Plaskos C
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Introduction. There is increasing pressure on healthcare providers to demonstrate competitiveness in quality, patient outcomes and cost. Robotic and computer-assisted total knee arthroplasty (TKA) have been shown to be more accurate than conventional TKA, thereby potentially improving quality and outcomes, however these technologies are usually associated with longer procedural times and higher costs for hospitals. The aim of this study was to determine the surgical efficiency, learning curve and early patient satisfaction of robotic-assisted TKA with a contemporary imageless system. Methods. The first 29 robotic-assisted TKA cases performed by a single surgeon having no prior experience with computer or robotic-assisted TKA were reviewed. System time stamps were extracted from computer surgical reports to determine the time taken from the first step in the anatomical registration process, the hip center acquisition, to the end of the last bone resection, the validation of the proximal tibial resection. Additional time metrics included: a) array attachment, b) anatomical registration, c) robotic-assisted femoral resection, d) tibial resection, e) trailing, f) implant insertion, and skin-to-skin time. The Residual Time was also calculated as the skin-to-skin time minus the time taken for steps a) to f), representing the time spent on all other steps of the procedure. Patients completed surveys at 3 months to determine their overall satisfaction with their surgical joint. Results. All time metrics decreased significantly after the first 7 cases, except the residual time (table 1 and figure 1). Mean skin-to-skin time significantly decreased from 83.7min to 57.1min (p=0.0008) beyond 7 cases, and hip center to final cut validation time decreased from 30.2min to 20.3min (p=0.0002). 85.7% (24/29) of patients were “Fully satisfied” and 14.3% (5/29) were “Partly satisfied”. Cost analysis showed there were no capital costs associated with acquisition of the robotic system and per case cost was equal to conventional TKA. Conclusion. Improvements in surgical efficiency and quality are becoming increasing important in today's healthcare environment. The results of this study indicated equal cost, a short learning curve and comparable procedure times to conventional TKA. The Patient Reported Outcomes with this group of patients was very high compared to rates reported in the literature


Bone & Joint Open
Vol. 5, Issue 8 | Pages 628 - 636
2 Aug 2024
Eachempati KK Parameswaran A Ponnala VK Sunil A Sheth NP

Aims. The aims of this study were: 1) to describe extended restricted kinematic alignment (E-rKA), a novel alignment strategy during robotic-assisted total knee arthroplasty (RA-TKA); 2) to compare residual medial compartment tightness following virtual surgical planning during RA-TKA using mechanical alignment (MA) and E-rKA, in the same set of osteoarthritic varus knees; 3) to assess the requirement of soft-tissue releases during RA-TKA using E-rKA; and 4) to compare the accuracy of surgical plan execution between knees managed with adjustments in component positioning alone, and those which require additional soft-tissue releases. Methods. Patients who underwent RA-TKA between January and December 2022 for primary varus osteoarthritis were included. Safe boundaries for E-rKA were defined. Residual medial compartment tightness was compared following virtual surgical planning using E-rKA and MA, in the same set of knees. Soft-tissue releases were documented. Errors in postoperative alignment in relation to planned alignment were compared between patients who did (group A) and did not (group B) require soft-tissue releases. Results. The use of E-rKA helped restore all knees within the predefined boundaries, with appropriate soft-tissue balancing. E-rKA compared with MA resulted in reduced residual medial tightness following surgical planning, in full extension (2.71 mm (SD 1.66) vs 5.16 mm (SD 3.10), respectively; p < 0.001), and 90° of flexion (2.52 mm (SD 1.63) vs 6.27 mm (SD 3.11), respectively; p < 0.001). Among the study population, 156 patients (78%) were managed with minor adjustments in component positioning alone, while 44 (22%) required additional soft-tissue releases. The mean errors in postoperative alignment were 0.53 mm and 0.26 mm among patients in group A and group B, respectively (p = 0.328). Conclusion. E-rKA is an effective and reproducible alignment strategy during RA-TKA, permitting a large proportion of patients to be managed without soft-tissue releases. The execution of minor alterations in component positioning within predefined multiplanar boundaries is a better starting point for gap management than soft-tissue releases. Cite this article: Bone Jt Open 2024;5(8):628–636


Bone & Joint Open
Vol. 1, Issue 2 | Pages 8 - 12
18 Feb 2020
Bhimani SJ Bhimani R Smith A Eccles C Smith L Malkani A

Aims. Robotic-assisted total knee arthroplasty (RA-TKA) has been introduced to provide accurate bone cuts and help achieve the target knee alignment, along with symmetric gap balancing. The purpose of this study was to determine if any early clinical benefits could be realized following TKA using robotic-assisted technology. Methods. In all, 140 consecutive patients undergoing RA-TKA and 127 consecutive patients undergoing conventional TKA with minimum six-week follow-up were reviewed. Differences in visual analogue scores (VAS) for pain at rest and with activity, postoperative opiate usage, and length of stay (LOS) between the RA-TKA and conventional TKA groups were compared. Results. Patients undergoing RA-TKA had lower average VAS pain scores at rest (p = 0.001) and with activity (p = 0.03) at two weeks following the index procedure. At the six-week interval, the RA-TKA group had lower VAS pain scores with rest (p = 0.03) and with activity (p = 0.02), and required 3.2 mg less morphine equivalents per day relative to the conventional group (p < 0.001). At six weeks, a significantly greater number of patients in the RA-TKA group were free of opioid use compared to the conventional TKA group; 70.7% vs 57.0% (p = 0.02). Patients in the RA-TKA group had a shorter LOS; 1.9 days versus 2.3 days (p < 0.001), and also had a greater percentage of patient discharged on postoperative day one; 41.3% vs 20.5% (p < 0.001). Conclusion. Patients undergoing RA-TKA had lower pain levels at both rest and with activity, required less opioid medication, and had a shorter LOS


Bone & Joint Research
Vol. 8, Issue 10 | Pages 495 - 501
1 Oct 2019
Hampp EL Sodhi N Scholl L Deren ME Yenna Z Westrich G Mont MA

Objectives. The use of the haptically bounded saw blades in robotic-assisted total knee arthroplasty (RTKA) can potentially help to limit surrounding soft-tissue injuries. However, there are limited data characterizing these injuries for cruciate-retaining (CR) TKA with the use of this technique. The objective of this cadaver study was to compare the extent of soft-tissue damage sustained through a robotic-assisted, haptically guided TKA (RATKA) versus a manual TKA (MTKA) approach. Methods. A total of 12 fresh-frozen pelvis-to-toe cadaver specimens were included. Four surgeons each prepared three RATKA and three MTKA specimens for cruciate-retaining TKAs. A RATKA was performed on one knee and a MTKA on the other. Postoperatively, two additional surgeons assessed and graded damage to 14 key anatomical structures in a blinded manner. Kruskal–Wallis hypothesis tests were performed to assess statistical differences in soft-tissue damage between RATKA and MTKA cases. Results. Significantly less damage occurred to the PCLs in the RATKA versus the MTKA specimens (p < 0.001). RATKA specimens had non-significantly less damage to the deep medial collateral ligaments (p = 0.149), iliotibial bands (p = 0.580), poplitei (p = 0.248), and patellar ligaments (p = 0.317). The remaining anatomical structures had minimal soft-tissue damage in all MTKA and RATKA specimens. Conclusion. The results of this study indicate that less soft-tissue damage may occur when utilizing RATKA compared with MTKA. These findings are likely due to the enhanced preoperative planning with the robotic software, the real-time intraoperative feedback, and the haptically bounded saw blade, all of which may help protect the surrounding soft tissues and ligaments. Cite this article: Bone Joint Res 2019;8:495–501


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 43 - 43
10 Feb 2023
Fary C Tripuraneni K Klar B Ren A Abshagen S Verheul R
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We sought to evaluate the early post-operative active range-of-motion (AROM) between robotic-assisted total knee arthroplasty (raTKA) and conventional TKA (cTKA). A secondary data analysis on a global prospective cohort study was performed. A propensity score method was used to select a matched control of cTKA from the same database using 1:1 ratio, based on age, sex, BMI, and comorbidity index. This resulted in 216 raTKA and cTKA matched cases. Multivariable longitudinal regression was used to evaluate difference in ROM over time and values are reported as least squares means (95% confidence interval). The longitudinal model tested the treatment effect (raTKA vs cTKA), time effect, and their interaction with control on covariance of patients ‘s age, sex, BMI, comorbidity and pre-operative flexion. Logistic regression was used to analyze the active flexion level at one month (cut by 90°) and three months (cut by 110°). At one-month postoperative the raTKA cases had more AROM for flexion by an average of 5.54 degrees (p<0.001). There was no difference at three months (p=0.228). The raTKA group had a greater improvement from pre-operative values at both one-month, with an average 7.07° (3.6°, 10.5°, p<0.001) more improvement, and at three-months with an average improvement of 4° more (1.61°, 7.24°, p=0.0115). AROM for extension was lower overall in the raTKA group by an average of 0.44° (p=0.029). The raTKA patients had higher odds of achieving ≥90° of flexion at one-month (OR 2.15, 95% CI 1.16, 3.99). raTKA resulted in greater AROM flexion gains in the early postoperative period than cTKA. Additional research is needed to understand if these earlier gains in AROM are associated with improved patient satisfaction and continued improvements with time


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 92 - 92
1 May 2016
Conditt M Gustke K Coon T Kreuzer S Branch S Bhowmik-Stoker M Abassi A
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Introduction. Total knee arthroplasty (TKA) is a well established treatment option for patients with end stage osteoarthritis. Conventional TKA with manual instruments has been shown to be a cost effective and time efficient surgery. While robotic-assisted operative systems have been shown to have benefits in surgical accuracy, they have also been reported to have longer surgical times. The purpose of this work was to determine surgical time and learning curve for a novel robotic-assisted TKA platform. Methods. Eighty-five subjects underwent robotic-assisted TKA by one of three investigators as part of an FDA and IRB approved Investigational Device Exemption (IDE). All patients received a cruciate retaining total knee implant system. Intra-operative safety, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee Society Scores (KSS) were collected pre-operatively and at three month follow-up. In addition, surgical times were collected as part of a TKA work flow. To identify activities related to surgical steps required for robotic procedures specific time stamps were determined from the system. Capture of the hip center to final bone cut was used to define case time and identify robotic learning curve. Descriptive statistics were used to analyze results. Results. Surgeon one completed 24 cases, surgeon two completed 32, and surgeon three completed 29 cases in the study. An average surgical time of 44 minutes with standard deviation of 15.7 minutes was recorded. On average surgeons improved in surgical time with increasing cases as indicated by linear regression results. During initial cases, surgeons repeated intra-operative planning steps which decreased with the learning curve. In addition, the average WOMAC score improvement from pre-operative to three months was 33.1 ± 20.04 (p<0.0001). The average KSS Knee score improvement was 46.12 ± 19.68 (p<0.0001). Subjects recovered their pre-operative range of motion by three months post-operative. Conclusion. With cost related pressures in healthcare, hospitals and surgeons focus on improvements in surgical efficiency to stay competitive. The results of this study indicated comparable operative times to conventional TKA cases as reported in literature with the added benefit of optimizing surgical accuracy. Robotic solutions in TKA may become increasingly efficient as surgeons complete a learning curve


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 62 - 62
1 Feb 2020
Kaper B
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Introduction. 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. Methods. 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. Results. A total of 625 patients were available for analysis. 270 RA-TKA and 355 CI-TKA. The results showed a trend toward higher scores for RA-TKA for KOOS overall (p-value = 0.20) and subspecialty scores at 1-year postop, especially for pain and quality of life (p-value = 0.13) and pain (p-value = 0.12). Discussion/Conclusion. In this preliminary study, patients undergoing RA-TKA demonstrated a trend toward higher PROM scores, especially in the categories of Quality of Life and Pain, when compared to CI-TKA. Due to the limited sample size, weighted 1.3:1 for CI-TKA, statistical significance was not shown. Because of the short timeframe available since the introduction of RA-TKA, further data collection and analysis will be necessary to re-assess statistically power in this comparison


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 60 - 60
1 Feb 2020
Kaper B
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Introduction/Aim. 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. Materials and Methods. 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. Results. No patients were lost to follow-up. During the study period, no intra-operative complications were recorded. Specifically, no complications related to the introduction of the high-speed burr associated with the NAVIO RA-TKA were noted. Within the 90-day follow-up period, there was one case of deep infection. One patient sustained a fall resulting in a peri-prosthetic femoral fracture, that occurred remote from the femoral pin tracts. No cases of axial or sagittal joint instability, axial mal-alignment, patello-femoral instability, pin site infections or fractures; or DVT/PE were identified. Four patients underwent manipulation under anesthesia. No other patients required a re-operation or re-admission due to surgical-related complications. Discussion/Conclusions. The initial experience with the NAVIO robotic assisted total knee arthroplasty has demonstrated excellent safety profile. Relative to known risks associated with total knee arthroplasty, no increased risk of peri-operative complications, re-operation or re-admission for surgical related complications was identified with the introduction of the NAVIO RA-TKA


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 98 - 98
1 Jun 2018
MacDonald S
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The use of robotics in total joint arthroplasty is the latest in a long list of expensive technologies that promise multiple positive outcomes, but come with an expensive price tag. In the last decade alone we've seen the same claims for navigation and patient specific instruments and implants. There are various current systems available including a robotic arm, robotic-guided cutting jigs and robotic milling systems. For robotics to be widely adopted it will need to address the following concerns, which as of 2017 it has not. 1). Cost - Very clearly the robotic units come with a significant price tag. Perhaps over time, like other technologies, they will reduce, but at present they are prohibitive for most institutions. 2). Outcomes - One could perhaps justify the increased costs if there was compelling evidence that either outcomes were improved or revision rates reduced. Neither of these has been proved in any type of randomised trial or registry captured data. As with any new technology one must be wary of the claims superseding the results. In 2017 the jury is still out on the cost vs. benefit of robotic-assisted TKA


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 120 - 120
1 Apr 2019
Koenig JA Neuhauser-Daley K Shalhoub S Plaskos C
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Introduction. Robotic systems have been used in TKA to add precision, although few studies have evaluated clinical outcomes. We report on early clinical results evaluating patient reported outcomes (PROs) on a series of robotic-assisted TKA (RAS-TKA) patients, and compare scores to those reported in the literature. Methods. We prospectively consented and enrolled 106 patients undergoing RAS-TKA by a single surgeon performing a measured-resection femur-first technique using a miniature bone-mounted robotic system. Patients completed a KOOS, New Knee Society Score (2011 KSS) and a Veterans RAND-12 (VR-12) pre-operatively and at 3, 6 and 12 months (M) post- operatively. At the time of publication 104, 101, and 78 patients had completed 3M, 6M, and 12M PROs, respectively. Changes in the five KOOS subscales (Pain, Symptoms, Activities of Daily Living (ADL), Sport and recreation function (Sport/Rec) and Knee-related Quality of Life (QOL)) were compared to available literature data from FORCE – TJR, a large, prospective, national cohort of TJR patients enrolled from diverse high-volume centers and community orthopaedic practices in the U.S, as well as to individual studies reporting on conventional (CON-TKA) and computer-assisted (CAS- TKA) at 3M, and on conventional TKA at 6M. The 2011 KSS is a validated method for quantifying patient's expectations and satisfaction with their TKA procedure. Improvements in the 2011 KSS were compared with literature data at 6M post-operatively. Results. RAS-TKA PRO's significantly improved at 3, 6, and 12M from pre-operative baseline values. When compared to the FORCE registry cohort data, the improvement in KOOS subscales were generally higher for RAS for pain at 6M, and for pain, ADL, and QOL at 1Y when compared with FORCE 2Y data. Higher improvements were also seen at 3M, except for Sports/Rec, and at 6M for symptoms and QOL when compared with smaller cohort studies. Improvements in 2011 KSS patient satisfaction and functional scores at 6M were 11 and 10 points greater than those reported for conventional TKA. A mean of 31 pts for the Patient Satisfaction score indicates that on average patients were ‘Satisfied’ with their knee function and pain level. Mean rates of dissatisfaction with knee pain level and function were 9.2%, 3.8% and 3.1% at 3, 6, and 12M postoperatively, respectively. A mean of 10pts for the Expectation score post-operatively indicates that on average patients felt their expectations for pain relief, ADL, and leisure/sports/rec activities were between “Just Right” or “Too Low”. Discussion. Early results of RAS-TKA demonstrated significant improvements in pain, function, and QOL from baseline pre-operative values. PROs for robotic TKA also compared favorably with results reported in the literature; however, additional randomized control studies are required to provide more meaningful comparisons with conventional techniques and with other advanced technologies


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 97 - 97
1 Jun 2018
Haas S
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Total knee arthroplasty is a successful procedure with good long-term results. Studies indicate that 15% – 25% of patients are dissatisfied with their total knee arthroplasty. In addition, return to sports activities is significantly lower than total hip arthroplasty with 34% – 42% of patients reporting decreased sports participation after their total knee arthroplasties. Poor outcomes and failures are often associated with technical errors. These include malalignment and poor ligament balancing. Malalignment has been reported in up to 25% of all revision knee arthroplasties, and instability is responsible for over 20% of failures. Most studies show that proper alignment within 3 degrees is obtained in only 70% – 80% of cases. Navigation has been shown in many studies to improve alignment. In 2015, Graves examined the Australian Joint Registry and found that computer navigated total knee arthroplasty was associated with a reduced revision rate in patients under 65 years of age. Navigation can improve alignment, but does not provide additional benefits of ligament balance. Robotic-assisted surgery can assist in many of the variables that influence outcomes of total knee arthroplasty including: implant positioning, soft tissue balance, lower limb alignment, proper sizing. The data on robotic-assisted unicompartmental arthroplasty is quite promising. Cytech showed that femoral and tibial alignment were both significantly more accurate than manual techniques with three times as many errors with the manually aligned patients. Pearle, et al. compared the cumulative revision rate at two years and showed this rate was significantly lower than data reported in most unicompartmental series, and lower revision rates than both Swedish and Australian registries. He also showed improved satisfaction scores at two years. Pagnano has noted that optimal alignment may require some deviation from mechanically neutral alignment and individualization may be preferred. This is also likely to be a requirement of more customised or bi-cruciate retaining implant designs. The precision of robotic surgery may be necessary to obtain this individualised component alignment. While robotic total knee arthroplasty requires further data to prove its value, more precise alignment and ligament balancing is likely to lead to improved outcomes, as Pearl, et al. and the Australian registry have shown. While it is difficult to predict the future at this time, I believe robotic-assisted total knee arthroplasty is the future and that future begins now


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 61 - 61
1 Feb 2020
Kaper B
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Introduction/Aim. 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. Materials and Methods. 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. Results. In the assessment of coronal-plane balance, the average deviation from the predicted plan between 0–90° was 0.9mm in both the medial and lateral compartments (range 0.5–1.2mm). In the mid-flexion arc (15–75°), final soft-tissue stability was within 1.0mm of the predictive plan (range 0.9–1.2mm). Discussion/Conclusions. In this study, NAVIO RA-TKA demonstrated a highly accurate and reproducible surgical technique to plan, execute and verify a balanced a soft-tissue envelope in TKA. Objective soft-tissue balancing of the TKA can now be performed, including the mid-flexion arc of motion. Further analysis can determine if these objective measurements will translate into improved patient-reported outcome scores


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 87 - 87
1 Feb 2017
Dabuzhsky L Neuhauser-Daley K Plaskos C
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Arthrofibrosis remains a dominant post-operative complication and reason for returning to the OR following total knee arthroplasty. Trauma induced by ligament releases during TKA soft tissue balancing and soft tissue imbalance are thought to be contributing factors to arthrofibrosis, which is commonly treated by manipulation under anesthesia (MUA). We hypothesized that a robotic-assisted ligament balancing technique where the femoral component position is planned in 3D based on ligament gap data would result in lower MUA rates than a measured resection technique where the implants are planned based solely on boney alignment data and ligaments are released afterwards to achieve balance. We also aimed to determine the degree of mechanical axis deviation from neutral that resulted from the ligament balancing technique. Methods. We retrospectively reviewed 301 consecutive primary TKA cases performed by a single surgeon. The first 102 consecutive cases were performed with a femur-first measured resection technique using computer navigation. The femoral component was positioned in neutral mechanical alignment and at 3° of external rotation relative to the posterior condylar axis. The tibia was resected perpendicular to the mechanical axis and ligaments were released as required until the soft tissues were sufficiently balanced. The subsequent 199 consecutive cases were performed with a tibia-first ligament balancing technique using a robotic-assisted TKA system. The tibia was resected perpendicular to the mechanical axis, and the relative positions of the femur and tibia were recorded in extension and flexion by inserting a spacer block of appropriate height in the medial and lateral compartments. The position, rotation, and size of the femoral component was then planned in all planes such that the ligament gaps were symmetric and balanced to within 1mm (Figure 1). Bone resection values were used to define acceptable limits of implant rotation: Femoral component alignment was adjusted to within 2° of varus or valgus, and within 0–3° of external rotation relative to the posterior condyles. Component flexion, anteroposterior and proximal-distal positioning were also adjusted to achieve balance in the sagittal plane. A robotic-assisted femoral cutting guide was then used to resect the femur according to the plan (Figure 2). CPT billing codes were reviewed to determine how many patients in each group underwent post-operative MUA. Post-operative mechanical alignment was measured in a subset of 50 consecutive patients in the ligament balancing group on standing long-leg radiographs by an independent observer. Results. Post-operative MUA rates were significantly lower in the ligament balancing group (0.5%; 1/199) than in the measured resection group (3.9%; 4/102), p=0.051. 91.3% (42/46) of knees were within 3° and 100% (46/46) were within 4° of neutral alignment to the mechanical axis post-operatively in the ligament balancing group. Conclusions. Gap driven femoral based planning in TKA resulted in a significantly lower post-operative manipulation rate than in the measured resection approach, while maintaining acceptable overall alignment to the mechanical axis


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 450 - 459
1 May 2024
Clement ND Galloway S Baron J Smith K Weir DJ Deehan DJ

Aims. The aim was to assess whether robotic-assisted total knee arthroplasty (rTKA) had greater knee-specific outcomes, improved fulfilment of expectations, health-related quality of life (HRQoL), and patient satisfaction when compared with manual TKA (mTKA). Methods. A randomized controlled trial was undertaken (May 2019 to December 2021), and patients were allocated to either mTKA or rTKA. A total of 100 patients were randomized, 50 to each group, of whom 43 rTKA and 38 mTKA patients were available for review at 12 months following surgery. There were no statistically significant preoperative differences between the groups. The minimal clinically important difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score was defined as 7.5 points. Results. There were no clinically or statistically significant differences between the knee-specific measures (WOMAC, Oxford Knee Score (OKS), Forgotten Joint Score (FJS)) or HRQoL measures (EuroQol five-dimension questionnaire (EQ-5D) and EuroQol visual analogue scale (EQ-VAS)) at 12 months between the groups. However, the rTKA group had significantly (p = 0.029) greater improvements in the WOMAC pain component (mean difference 9.7, 95% confidence interval (CI) 1.0 to 18.4) over the postoperative period (two, six, and 12 months), which was clinically meaningful. This was not observed for function (p = 0.248) or total (p = 0.147) WOMAC scores. The rTKA group was significantly (p = 0.039) more likely to have expectation of ‘Relief of daytime pain in the joint’ when compared with the mTKA group. There were no other significant differences in expectations met between the groups. There was no significant difference in patient satisfaction with their knee (p = 0.464), return to work (p = 0.464), activities (p = 0.293), or pain (p = 0.701). Conclusion. Patients undergoing rTKA had a clinically meaningful greater improvement in their knee pain over the first 12 months, and were more likely to have fulfilment of their expectation of daytime pain relief compared with patients undergoing mTKA. However, rTKA was not associated with a clinically significant greater knee-specific function or HRQoL, according to current definitions. Cite this article: Bone Joint J 2024;106-B(5):450–459


Bone & Joint Open
Vol. 3, Issue 7 | Pages 589 - 595
1 Jul 2022
Joo PY Chen AF Richards J Law TY Taylor K Marchand K Clark G Collopy D Marchand RC Roche M Mont MA Malkani AL

Aims. The aim of this study was to report patient and clinical outcomes following robotic-assisted total knee arthroplasty (RA-TKA) at multiple institutions with a minimum two-year follow-up. Methods. This was a multicentre registry study from October 2016 to June 2021 that included 861 primary RA-TKA patients who completed at least one pre- and postoperative patient-reported outcome measure (PROM) questionnaire, including Forgotten Joint Score (FJS), Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS JR), and pain out of 100 points. The mean age was 67 years (35 to 86), 452 were male (53%), mean BMI was 31.5 kg/m. 2. (19 to 58), and 553 (64%) cemented and 308 (36%) cementless implants. Results. There were significant improvements in PROMs over time between preoperative, one- to two-year, and > two-year follow-up, with a mean FJS of 17.5 (SD 18.2), 70.2 (SD 27.8), and 76.7 (SD 25.8; p < 0.001); mean KOOS JR of 51.6 (SD 11.5), 85.1 (SD 13.8), and 87.9 (SD 13.0; p < 0.001); and mean pain scores of 65.7 (SD 20.4), 13.0 (SD 19.1), and 11.3 (SD 19.9; p < 0.001), respectively. There were eight superficial infections (0.9%) and four revisions (0.5%). Conclusion. RA-TKA demonstrated consistent clinical results across multiple institutions with excellent PROMs that continued to improve over time. With the ability to achieve target alignment in the coronal, axial, and sagittal planes and provide intraoperative real-time data to obtain balanced gaps, RA-TKA demonstrated excellent clinical outcomes and PROMs in this patient population. Cite this article: Bone Jt Open 2022;3(7):589–595


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 86 - 86
1 Mar 2017
Plaskos C Dabuzhsky L Gill P Jevsevar D Keggi J Koenig J Moschetti W Sydney S Todorov A Joly C
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We introduce a novel active tensioning system that can be used for dynamic gap-based implant planning as well as for assessment of final soft tissue balance during implant trialing. We report on the concept development and preliminary findings observed during early feasibility testing in cadavers with two prototype systems. System description. The active spacer (fig 1) consists of a motorized actuator unit with integrated force sensors, independently actuated medial and lateral upper arms, and a set of modular attachments for replicating the range of tibial baseplate and insert trial sizes. The spacer can be controlled in either force or position (gap) control and is integrated into the OMNIBotics. TM. Robotic-assisted TKA platform (OMNI, MA, USA). Cadaver Study. Two design iterations were evaluated on eleven cadaver specimens by seven orthopaedic surgeons in three separate cadaver labs. The active spacer was used in a tibial-first technique to apply loads and measure gaps prior to and after femoral resections. To determine the range of forces applied on the spacer during a varus/valgus assessment procedure, each surgeon performed a varus/valgus stress test and peak medial and lateral forces were measured. Surgeons also rated the feel of the stability of the knee at 50N and 80N of preload using the following scale: 1 – too loose; 2 – slightly loose; 3 – ideal; 4 slightly tight; 5 – too tight. Final balanced was assessed with the spacer and with manual trial components. Results. Overall the prototype system successfully met the functional requirements for applying controlled tension during ligament balancing, and user feedback on usability and feasibility for use in TKA was highly positive. Peak forces measured during blinded stability assessments were significantly imbalanced from medial to lateral and exhibited a wide range across users (range: 70N – 310N, table 1). Each surgeon rated 50N of tension as feeling “slightly loose” and 80N as feeling “ideal” in extension. “Ideal” soft tissue balance was achieved in the last three knees tested using the second design iteration, as rated by the surgeons with final trial components in place. Discussion. Our preliminary cadaver results have established the initial feasibility of the active spacer concept for applying tension during ligament balancing and implant planning. Our initial results also suggest that performing a varus/valgus assessment without force readings can lead to imbalanced mediolateral load application. This may be due to factors such as hand dominance and pulling in varus versus pushing in valgus. There was also considerable inter-surgeon variability in the peak forces applied. An advantage of computer-controlled ligament tensioning and force sensing is ability to standardize applied mediolateral forces across patients and surgeons. In the assessment of the ‘ideal' static ligament tension in extension a force of 80N was preferred over 50N, which is in the range of forces applied by others during ligament balancing. What is the ideal patient specific force to apply remains a topic of future research. Our next steps will be to further evaluate use of the system in the context of virtual trialing


Bone & Joint Open
Vol. 5, Issue 9 | Pages 758 - 765
12 Sep 2024
Gardner J Roman ER Bhimani R Mashni SJ Whitaker JE Smith LS Swiergosz A Malkani AL

Aims. Patient dissatisfaction following primary total knee arthroplasty (TKA) with manual jig-based instruments has been reported to be as high as 30%. Robotic-assisted total knee arthroplasty (RA-TKA) has been increasingly used in an effort to improve patient outcomes, however there is a paucity of literature examining patient satisfaction after RA-TKA. This study aims to identify the incidence of patients who were not satisfied following RA-TKA and to determine factors associated with higher levels of dissatisfaction. Methods. This was a retrospective review of 674 patients who underwent primary TKA between October 2016 and September 2020 with a minimum two-year follow-up. A five-point Likert satisfaction score was used to place patients into two groups: Group A were those who were very dissatisfied, dissatisfied, or neutral (Likert score 1 to 3) and Group B were those who were satisfied or very satisfied (Likert score 4 to 5). Patient demographic data, as well as preoperative and postoperative patient-reported outcome measures, were compared between groups. Results. Overall, 45 patients (6.7%) were in Group A and 629 (93.3%) were in Group B. Group A (vs Group B) had a higher proportion of male sex (p = 0.008), preoperative chronic opioid use (p < 0.001), preoperative psychotropic medication use (p = 0.01), prior anterior cruciate ligament (ACL) reconstruction (p < 0.001), and preoperative symptomatic lumbar spine disease (p = 0.004). Group A was also younger (p = 0.023). Multivariate analysis revealed preoperative opioid use (p = 0.012), prior ACL reconstruction (p = 0.038), male sex (p = 0.006), and preoperative psychotropic medication use (p = 0.001) as independent predictive factors of patient dissatisfaction. Conclusion. The use of RA-TKA demonstrated a high rate of patient satisfaction (629 of 674, 93.3%). Demographics for patients not satisfied following RA-TKA included: male sex, chronic opioid use, chronic psychotropic medication use, and prior ACL reconstruction. Patients in these groups should be identified preoperatively and educated on realistic expectations given their comorbid conditions. Cite this article: Bone Jt Open 2024;5(9):758–765


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 43 - 43
1 Feb 2020
Mont M Kinsey T Zhang J Bhowmik-Stoker M Chen A Orozco F Hozack W Mahoney O
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Introduction. Component position and overall limb alignment following total knee arthroplasty (TKA) have been shown to influence prosthetic survivorship and clinical outcomes. Robotic-assisted (RA) total knee arthroplasty has demonstrated improved accuracy to plan in cadaver studies compared to conventionally instrumented (manual) TKA, but less clinical evidence has been reported. The objective of this study was to compare the three-dimensional accuracy to plan of RATKA with manual TKA for overall limb alignment and component position. Methods. A non-randomized, prospective multi-center clinical study was conducted to compare RATKA and manual TKA at 4 U.S. centers between July 2016 and August 2018. Computed tomography (CT) scans obtained approximately 6 weeks post-operatively were analyzed using anatomical landmarks. Absolute deviation from surgical plans were defined as the absolute value of the difference between the CT measurements and surgeons’ operative plan for overall limb, femoral and tibial component mechanical varus/valgus alignment, tibial component posterior slope, and femoral component internal/external rotation. We tested the differences of absolute deviation from plan between manual and RATKA groups using stratified Wilcoxon tests, which controlled for study center and accounted for skewed distributions of the absolute values. Alpha was 0.05 two-sided. At the time of this abstract, data collections were completed for two centers (52 manual and 58 RATKA). Results. Comparing absolute deviation from plan between groups, RATKA demonstrated clear benefits for tibial component alignment (median absolute deviation from plan: 1.5° vs. 0.8°, manual vs RATKA, p<.001), tibial slope (2.7° vs. 1.1°, manual vs RATKA, p<.001), and femoral component rotation (1.4° vs. 0.9°, manual vs RATKA, p<0.02). Femoral component and overall limb alignment accuracy were comparable (p>0.10). Discussion and Conclusions. In this study, compared to manual TKA, RATKA cases were 47% more accurate for tibial component alignment, 59% more accurate for tibial slope, and 36% more accurate for femoral component rotation (percent differences of median absolute deviations from plan). Further clinical data is needed to study the longer-term benefits of robotic technologies. Nevertheless, this study supports improved accuracy to plan utilizing RATKA compared to manual TKA. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 59 - 59
1 Feb 2020
Zhang J Bhowmik-Stoker M Yanoso-Scholl L Condrey C Marchand K Marchand R
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Introduction

Valgus deformity in an end stage osteoarthritic knee can be difficult to correct with no clear consensus on case management. Dependent on if the joint can be reduced and the degree of medial laxity or distension, a surgeon must use their discretion on the correct method for adequate lateral releases. Robotic assisted (RA) technology has been shown to have three dimensional (3D) cut accuracy which could assist with addressing these complex cases. The purpose of this work was to determine the number of soft tissue releases and component orientation of valgus cases performed with RA total knee arthroplasty (TKA).

Methods

This study was a retrospective chart review of 72 RATKA cases with valgus deformity pre-operatively performed by a single surgeon from July 2016 to December 2017. Initial and final 3D component alignment, knee balancing gaps, component size, and full or partial releases were collected intraoperatively. Post-operatively, radiographs, adverse events, WOMAC total and KOOS Jr scores were collected at 6 months, 1 year and 2 year post-operatively.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 44 - 44
1 Feb 2020
Zhang J Bhowmik-Stoker M Yanoso-Scholl L Condrey C Marchand K Hitt K Marchand R
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Introduction

Studies have shown that dissatisfaction following TKA may stem from poor component placement and iatrogenic factors related to variability in surgical execution. A CT-based robotic assisted system (RA) allows surgeons to dynamically balance the joint prior to bone resection. This study aimed to determine if this system could improve TKA planning, reduce soft tissue releases, minimize bone resection, and accurately predict component size in varus knee.

Method

Four hundred and seventy four cases with varus deformity undergoing primary RATKA were enrolled in this prospective, single center and surgeon study. Patient demographics and intraoperative surgical details were collected. Initial and final 3-dimensional alignment, component position, bone resection depths, use of soft tissue releases, knee balancing gaps, and component size were collected intraoperatively. WOMAC and KOOS Jr. scores were collected 6 months, and 1 year postoperatively. Descriptive statistics were applied to determine the changes in these parameters between initial and final values.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 28 - 28
1 Oct 2020
Deckey DG Rosenow CS Verhey JT Mayfield CK Christopher ZK Clarke HD Bingham JS
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Introduction

Robot-assisted total knee arthroplasty (RA-TKA) is theoretically more accurate for component positioning than TKA performed with mechanical instruments (M-TKA). Furthermore, the ability to quantify soft tissue laxity and adjust the plan prior to bone resection should reduce variability in polyethylene thickness. This study was performed to compare accuracy to plan for component positioning and polyethylene thickness in RA-TKA versus M-TKA.

Methods

199 consecutive primary TKAs (96 C-TKA and 103 RA-TKA) performed by a single surgeon were reviewed. Full-length standing and knee radiographs were obtained pre and post-operatively. For M-TKA, measured resection technique was used. Planned coronal plane femoral and tibial component alignment, and overall limb alignment were all 0° to the mechanical axis; tibial posterior slope was 2°; and polyethylene thickness was 9mm. For RA-TKA, individual component position was adjusted to assist balance the gaps but planned coronal plane alignment for the femoral and tibial components and overall limb alignment had to remain 0+/− 3°; planned tibial posterior slope was 1.5°. Planned values and polyethylene thickness for RA-TKA were obtained from the final intra-operative plan. Mean deviations from plan for each parameter were compared between groups (ΔFemur, ΔTibia, ΔPS, and polyethylene thickness) as were distal femoral recut and tourniquet time.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 60 - 60
1 Feb 2020
Zhang J Persohn S Bhowmik-Stoker M Otto J Paramasivam M Wahdan A Choplin R Territo P
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Introduction

Component position and overall limb alignment following Total Knee Arthroplasty (TKA) have been shown to influence device survivorship and clinical outcomes. However current methods for measuring post-operative alignment through 2D radiographs and CTs may be prone to inaccuracies due to variations in patient positioning, and certain anatomical configurations such as rotation and flexion contractures. The purpose of this paper is to develop a new vector based method for overall limb alignment and component position measurements using CT. The technique utilizes a new mathematical model to calculate prosthesis alignment from the coordinates of anatomical landmarks. The hypothesis is that the proposed technique demonstrated good accuracy to surgical plan, as well as low intra and inter-observer variability.

Methods

This study received institutional review board approval. A total of 30 patients who underwent robotic assisted TKA (RATKA) at four different sites between March 2017 and January 2018 were enrolled in this prospective, multicenter, non-randomized clinical study. CT scans were performed prior to and 4–6 weeks post-operatively. Each subject was positioned headfirst supine with the legs in a neutral position and the knees at full extension. Three separate CT scans were performed at the anatomical location of the hip, knee, and ankle joint. Hip, knee, and ankle images were viewed in 3D software and the following vertices were generated using anatomical landmarks: Hip Center (HC), Medial Epicondyle Sulcus (MES), Lateral Epicondyle (LE), Femur Center (FC), Tibia Center (TC), Medial Malleolus (MM), Lateral Malleolus (LM), Femur Component Superior (FCS), Femur Component Inferior (FCI), Coronal Femoral Lateral (CFL), Coronal Femoral Medial (CFM), Coronal Tibia Lateral (CTL), and Coronal Tibia Medial (CTM). Limb alignment and component positions were calculated from these vertices using a new mathematical model.

The measurements were compared to the surgeons’ operative plan and component targeted positions for accuracy analysis. Two analysts performed the same measurements separately for inter-observer variability analysis. One of the two analysts repeated the measurements at least 30 days apart to assess intra-observer variability. Correlation analysis was performed on the intra-observer analysis, while Bland Altman analysis was performed on the inter-observer analysis.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 38 - 38
1 Feb 2021
Hickey M Anglin C Masri B Hodgson A
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Introduction

Innovations in surgical robotics and navigation have significantly improved implant placement accuracy in total knee arthroplasty (TKA). However, many comparative studies have not been shown to substantially improve revision rates or other clinical outcome scores. We conducted a simulation study based on the reported distribution of patient-specific characteristics and estimated potential effect of coronal plane alignment (CPA) on risk of revision to evaluate the hypothesis that most published study designs in this area have been too underpowered to detect improvements in revision rates.

Methods

To model previously reported studies, we generated a series of simulated TKA patient populations, assigning each patient a set of patient-specific factors (age at index surgery, BMI, and sex (Fig.1a)), as well as one surgeon-controlled factor (CPA) (Fig.1b) based on registry data and published literature. We modelled the survival probability for an individual patient at time t as a Gaussian function (exp[-(t/(kτmax))2]), where τmax (99.5 years) is selected to ensure the mean survival probability of the patient population matched 92% at 15 years. The value of k was adjusted for simulated patients within a range of 0 to 1 as a function of their patient and surgeon-specific factors (Fig.2).

To evaluate power associated with a study design, we ran a Monte Carlo simulation generating 10,000 simulated populations of ten different cohort sizes. We divided the patient population into two groups: one group was assigned CPAs governed by the precision of a navigated/robotic approach (σ=1.5°), and the other CPAs governed by the precision of a conventional approach (σ=3°). We then simulated the time to failure for each patient, computed the corresponding Kaplan-Meier survival curves, and applied a Log-Rank test to each study to test for statistical difference. From the 10,000 simulations associated with each cohort size, we determined the percentage of simulated studies that found a statistically significant difference at each time point.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 59 - 59
1 Feb 2020
Kaper B
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Introduction

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).

Materials and Methods

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.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 71 - 71
1 Oct 2018
Cool CL Mont MA Jacofsky DJ
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Introduction

Robotic assisted Total Knee Arthroplasty (rTKA), provides surgeons with preoperative planning and real-time data allowing for continuous assessment of ligamentous tension and range-of-motion. Using this technology, soft tissue protection, reduced early post-operative pain and improved patient satisfaction have been shown. These advances have the potential to enhance surgical outcomes and may also reduce episode-of-care (EOC) costs for patients, payers, and hospitals. The purpose of this study was to compare robotic assisted vs. manual total knee arthroplasty: 1) 90-day episode-of-care (EOC) costs; 2) index costs; 3) lengths-of-stay (LOS); 4) discharge disposition; and 5) readmission rates.

Methods

TKA procedures were identified using the Medicare 100% Standard Analytic Files including; Inpatient, Outpatient, Skilled Nursing (SNF) and Home Health. Members included patients with rTKA or manual TKA (mTKA) between 1/1/2016-3/31/2017. To account for potential baseline differences, propensity score matching (PSM) was performed in a 1-to-5 ratio, robotic to manual based on age, sex, race, geographic division, and comorbidities. After PSM, 519 rTKA and 2,595 mTKA were identified and included for analysis. Ninety-day episode-of-care cost, index cost, LOS, discharge disposition and readmission rates were assessed.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_20 | Pages 72 - 72
1 Dec 2017
Shalhoub S Plaskos C Moschetti WE Jevsevar DS Dabuzhsky L Keggi JM
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Gap balancing technique aims to achieve equal and symmetric gap at full extension and in flexion; however, little is known about the connection between the native and the replaced knee gaps. In this study, a novel robotic assisted ligament tensioning tool was used to measure the pre- and post- operative gaps to better understand their relationship when aiming for balance gaps in flexion and extension. The accuracy of a prediction algorithm for the post-operative gaps based on the native gap and implant alignment was evaluated in this study. The medial and lateral gap were smallest at full extension. The native gaps increase with flexion until 30 degrees where they plateaued for the remaining flexion range. The native lateral gap was larger than the medial gap throughout the flexion range. Planning for equal gaps at extension and flexion resulted with tightest gaps at these angle; however, the gaps in mid-flexion were 3–4 mm larger. Good agreement was observed between the post-operative results and the predicted gas from the software algorithm. The results showed that the native gaps are neither symmetric nor equal. In addition, aiming for equal gaps reduces the variation at these angles but could result in mid- flexion laxity. Advanced robotics-assisted instrumentation can aid in evaluation of soft-tissue and help in surgical planning of TKA. This allows the surgeon to achieve the targeted outcome as well as record the final implant tension to correlate with clinical outcomes.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 62 - 62
1 Aug 2013
Koenig J Plaskos C
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Introduction

We evaluated the utility of imageless computer-navigation coupled with a miniature robotic-cutting guide for managing large deformities in TKA. We asked what effect did severe pre-operative deformities have on post-operative alignment and surgery time using the system. We also report on the early functional outcomes of this group of patients.

Methods

This was a retrospective cohort study of 128 TKA's performed by a single surgeon (mean age: 71y/o [range 53–93], BMI: 31.1 [20–44.3], 48males). Patients were stratified into three groups according to their pre-operative coronal plane deformity: Neutral or mild deformity <10((baseline group); Severe varus ≥10(; severe valgus ≥10(; and according to the degree of flexion contracture: Neutral or mild flexion from −5(hyperextension to 10(flexion (baseline group); hyperextension ≤−5(, and severe flexion ≥10. (The degree of deformity and final postoperative alignment achieved was measured using computer navigation in all patients and analysed using multivariate regression. The APEX CR/Ultra Knee System (OMNIlife Science, Inc.) was used with the PRAXIM Navigation system in all cases. A students t-test was used to compare pre- and post-operative (3–6 months) Knee Society Scores (KSS) and Knee Functional Scores (KSSF) for all patients.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 11 - 11
1 Oct 2019
Held MB Grosso MJ Gazgalis A Sarpong NO Jennings E Shah RP Cooper HJ Geller JA
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Introduction. Robotic-assisted total knee arthroplasty (TKA) was introduced to improve limb alignment, component positioning, and soft-tissue balance, yet the effect of adoption of this technology has not been established. This study was designed to evaluate whether robotic-assisted TKA leads to improved patient reported outcome measures (PROMs) and patient satisfaction as compared to conventional TKA at 3 and 12 months. Methods. This IRB-approved single-surgeon retrospective cohort analysis of prospectively collected data compared 113 conventional TKA patients with 145 imageless robotic-assisted TKA patients (Navio™ Surgical System, Smith&Nephew®, Memphis TN). Basic demographic information, intraoperative and postoperative data, and PROMs (SF-P, SF-M, WOMAC pain, WOMAC stiffness, WOMAC Physical Function, KSS) were collected and recorded preoperatively, at 3 months, and at 12 months following surgery. Range of motion (ROM), blood loss, surgical duration, and complication rates between groups were also collected. Continuous measures such as mean difference in PROMs and ROM were compared using unpaired t-tests. Categorical measures such as the percentage of patients with complications were compared using chi-square analysis. Results. There were no baseline demographic differences or preoperative PROMs between groups. Following TKA, there were no differences between groups with respect to ROM or any of the PROMs (SF-P, SF-M, WOMAC pain, WOMAC stiffness, WOMAC Physical Function, and KS scores) at 3- or 12-months. Difference between the group included larger EBL(242 vs 209 mL, p<.001) and longer surgical duration (119 vs 107minutes, p<.001) for robotic-assisted surgery. There were no differences between the two groups in total post operative complications however subgroup analysis demonstrated that the robotic assisted cohort had fewer periprosthetic joint infections (1 vs 3, p=.048) and total reoperations (1 vs 7, p=.0114). Conclusions. Imageless robotic-assisted TKA resulted in similar function and satisfaction scores when compared to conventional TKA at 3 and 12 months. While EBL and surgical duration were greater with robotic-assisted TKA, this technique resulted in fewer reoperations and periprosthetic wound infections. For figures, tables, or references, please contact authors directly


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 58 - 58
1 Feb 2021
Sires J Wilson C
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Robotic-assisted technology in total knee arthroplasty (TKA) aims to increase implantation accuracy, with real-time data being used to estimate intraoperative component alignment. Postoperatively, Perth computed tomography (CT) protocol is a valid measurement technique in determining both femoral and tibial component alignments. The aim of this study was to evaluate the accuracy of intraoperative component alignment by robotic-assisted TKA through CT validation. A total of 33 patients underwent TKA using the MAKO robotic-assisted TKA system. Intraoperative measurements of both femoral and tibial component placements, as well as limb alignment as determined by the MAKO software were recorded. Independent postoperative Perth CT protocol was obtained (n.29) and compared with intraoperative values. Mean absolute difference between intraoperative and postoperative measurements for the femoral component were 1.17 degrees (1.10) in the coronal plane, 1.79 degrees (1.12) in the sagittal plane, and 1.90 degrees (1.88) in the transverse plane. Mean absolute difference between intraoperative and postoperative measurements for the tibial component were 1.03 degrees (0.76) in the coronal plane and 1.78 degrees (1.20) in the sagittal plane. Mean absolute difference of limb alignment was 1.29 degrees (1.25), with 93.10% of measurements within 3 degrees of postoperative CT measurements. Overall, intraoperatively measured component alignment as estimated by the MAKO robotic-assisted TKA system is comparable to CT-based measurements


Bone & Joint Open
Vol. 4, Issue 1 | Pages 13 - 18
5 Jan 2023
Walgrave S Oussedik S

Abstract. Robotic-assisted total knee arthroplasty (TKA) has proven higher accuracy, fewer alignment outliers, and improved short-term clinical outcomes when compared to conventional TKA. However, evidence of cost-effectiveness and individual superiority of one system over another is the subject of further research. Despite its growing adoption rate, published results are still limited and comparative studies are scarce. This review compares characteristics and performance of five currently available systems, focusing on the information and feedback each system provides to the surgeon, what the systems allow the surgeon to modify during the operation, and how each system then aids execution of the surgical plan. Cite this article: Bone Jt Open 2023;4(1):13–18


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_8 | Pages 7 - 7
10 May 2024
Zaidi F Goplen CM Fitz-Gerald C Bolam SM Hanlon M Munro J Monk AP
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Introduction. Recent technological advancements have led to the introduction of robotic-assisted total knee arthroplasty to improve the accuracy and precision of bony resections and implant position. However, the in vivo accuracy is not widely reported. The primary objective of this study is to determine the accuracy and precision of a cut block positioning robotic arm. Method. Seventy-seven patients underwent total knee arthroplasty with various workflows and alignment targets by three arthroplasty-trained surgeons with previous experience using the ROSA® Knee System. Accuracy and precision were determined by measuring the difference between various workflow time points, including the final pre-operative plan, validated resection angle, and post-operative radiographs. The mean difference between the measurements determined accuracy, and the standard deviation represented precision. Results. The accuracy and precision for all angles comparing the final planned resection and validated resection angles was 0.90° ± 0.76°. The proportion within 3° ranged from 97.9% to 100%. The accuracy and precision for all angles comparing the final intra- operative plan and post-operative radiographs was 1.95 ± 1.48°. The proportion of patients within 3° was 93.2%, 95.3%, 96.6%, and 71.4% for the distal femur, proximal tibia, femoral flexion, and tibial slope angles when the final intra-operative plan was compared to post-operative radiographs. No patients had a postoperative complication requiring revision at the final follow-up. Conclusions. This study demonstrates that the ROSA Knee System has accurate and precise coronal plane resections with few outliers. However, the tibial slope demonstrated decreased accuracy and precision were measured on post-operative short-leg lateral radiographs with this platform


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 68 - 68
10 Feb 2023
Zaidi F Bolam S Yeung T Besier T Hanlon M Munro J Monk A
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Patient-reported outcome measures (PROMs) have failed to highlight differences in function or outcome when comparing knee replacement designs and implantation techniques. Ankle-worn inertial measurement units (IMUs) can be used to remotely measure and monitor the bi-lateral impact load of patients, augmenting traditional PROMs with objective data. The aim of this study was to compare IMU-based impact loads with PROMs in patients who had undergone conventional total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), and robotic-assisted TKA (RA-TKA). 77 patients undergoing primary knee arthroplasty (29 RA-TKA, 37 TKA, and 11 UKA) for osteoarthritis were prospectively enrolled. Remote patient monitoring was performed pre-operatively, then weekly from post-operative weeks two to six using ankle-worn IMUs and PROMs. IMU-based outcomes included: cumulative impact load, bone stimulus, and impact load asymmetry. PROMs scores included: Oxford Knee Score (OKS), EuroQol Five-dimension with EuroQol visual analogue scale, and the Forgotten Joint Score. On average, patients showed improved impact load asymmetry by 67% (p=0.001), bone stimulus by 41% (p<0.001), and cumulative impact load by 121% (p=0.035) between post-operative week two and six. Differences in IMU-based outcomes were observed in the initial six weeks post-operatively between surgical procedures. The mean change scores for OKS were 7.5 (RA-TKA), 11.4 (TKA), and 11.2 (UKA) over the early post-operative period (p=0.144). Improvements in OKS were consistent with IMU outcomes in the RA-TKA group, however, conventional TKA and UKA groups did not reflect the same trend in improvement as OKS, demonstrating a functional decline. Our data illustrate that PROMs do not necessarily align with patient function, with some patients reporting good PROMs, yet show a decline in cumulative impact load or load asymmetry. These data also provide evidence for a difference in the functional outcome of TKA and UKA patients that might be overlooked by using PROMs alone


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 73 - 73
1 Feb 2020
Catani F Ensini A Zambianchi F Illuminati A Matveitchouk N
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Introduction. Robotics have been applied to total knee arthroplasty (TKA) to improve surgical precision in components’ placement, providing a physiologic ligament tensioning throughout knee range of motion. The purpose of the present study is to evaluate femoral and tibial components’ positioning in robotic-assisted TKA after fine-tuning according to soft tissue tensioning, aiming symmetric and balanced medial and lateral gaps in flexion/extension. Materials and Methods. Forty-three consecutive patients undergoing robotic-assisted TKA between November 2017 and November 2018 were included. Pre-operative radiographs were performed and measured according to Paley's. The tibial and femoral cuts were performed based on the individual intra-operative fine-tuning, checking for components’ size and placement, aiming symmetric medial and lateral gaps in flexion/extension. Cuts were adapted to radiographic epiphyseal anatomy and respecting ±2° boundaries from neutral coronal alignment. Robotic data were recorded, collecting information relative to medial and lateral gaps in flexion and extension. Results. Patients were divided based on the pre-operative coronal mechanical femoro-tibial angle (mFTA). Only knees with varus deformity (mFTA<178°), 29 cases, were taken into account. On average, the tibial component was placed at 1.2°±0.5 varus. Femoral component fine-tuning based on soft-tissues tensioning in extension and flexion determined the following alignments: 0.2°±1.2 varus on the coronal plane and 1.2°±2.2° external rotation with respect to the trans-epicondylar axis (TEA) as measured on the CT scan in the horizontal plane. The average gaps after femoral and tibial resections, resulted as follows: 19.5±0.8 mm on the medial side in extension, 20.0±0.9 mm on the lateral side in extension, 19.1±0.7 mm on the medial side in flexion and 19.5±0.7 mm on the lateral side in flexion. On average, the post-implant coronal alignment as reported by the robotic system resulted 2.0°±1.5 varus. Discussion. The proposed robotic-arm assisted TKA technique, aiming to preserve the integrity of the ligaments, provides balanced and symmetric gaps in flexion and extension and an anatomic femoral and tibial component's placement with post-implant coronal alignment within ±2° from neutral alignment


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 124 - 124
1 Apr 2019
King C Edgington J Perrone M Wlodarski C Wixson R Puri L
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Background/Introduction. As a new generation of robotic systems is introduced into the world of arthroplasty, Robotic-Assisted Total Knee Arthroplasty (TKA) represents a growing proportion of a reconstructive surgeon's operative volume. This study aims to compare the post-operative readmission rate, pain scores, costs, as well as the effects on surgeon efficiency one year after adoption of these technologies into clinical practice. Methods. A retrospective chart review was conducted regarding all conventional and robotic-assisted TKAs performed by a single surgeon in the year following January 1, 2017, the date MAKO Robotic-Assisted TKAs were introduced at our intuition. All patients over age 18 with a diagnosis of primary osteoarthritis of the knee who underwent TKA during this period were identified. Records were analyzed for differences in readmission, pain scores, tourniquet time, and operating room charges. Results. A total of 208 patients met inclusion criteria and were included in this analysis (97 Robotic-Assisted TKAs & 111 conventional TKAs). Robotic-Assisted TKAs incurred a mean total OR cost of $44,785 in the first quarter of implementation. This decreased to $43,124 over the subsequent year. Conventional TKAs incurred a mean total OR cost of $41,277. Among Robotic-Assisted TKAs, the mean tourniquet time was 70 minutes in the first month the technology was implemented. Mean tourniquet time for conventional TKAs was 42 minutes. Over time, variance in tourniquet times decreased substantially and tourniquet time for Robotic-Assisted TKAs trended towards being time neutral (49 minutes) (P=0.001). More importantly, in this study Robotic-Assisted TKAs were readmitted at a rate of only 1% (1/97). This represents a substantial reduction in readmission when compared to conventional TKAs, which were readmitted at a rate of 4.5% (5/111) (P=0.13). Interestingly, Robotic-Assisted TKAs averaged lower pain scores (2.9) compared to conventional TKAs (3.2), a finding that trended towards significance (P=0.13). Discussion/Conclusions. Implementation of Robotic-Assisted TKA resulted in an initial increase in mean OR cost and tourniquet time. Although there is a learning curve with specific regard to surgeon efficiency, there was no increase in the rate of complications and the trend in tourniquet time approached being time neutral one year after implementation. Though Robotic-Assisted TKAs continue to represent an increased cost burden compared to conventional TKAs, this may be offset by lower pain scores and more importantly a substantial reduction in post-operative readmission. Since readmissions represent a relatively rare occurrence following TKA, further large-scale studies are required to validate this preliminary data


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 52 - 52
1 Feb 2021
De Grave PW Luyckx T Claeys K Gunst P
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Purpose. Various alignment philosophies for total knee arthroplasty (TKA) have been described, all striving to achieve excellent long-term implant survival and good functional outcomes. In recent years, in search of higher functionality and patient satisfaction, a shift towards more patient-specific alignment is seen. Robotics is the perfect technology to tailor alignment. The purpose of this study was to describe ‘inverse kinematic alignment’ (iKA) technique, and to compare clinical outcomes of patients that underwent robotic-assisted TKA performed by iKA versus adjusted mechanical alignment (aMA). Methods. The authors analysed the records of a consecutive series of patients that received robotic assisted TKA with iKA (n=40) and with aMA (n=40). Oxford Knee Score (OKS) and satisfaction on a visual analogue scale (VAS) were collected at a follow-up of 12 months. Clinical outcomes were assessed according to patient acceptable symptom state (PASS) thresholds, and uni- and multivariable linear regression analyses were performed to determine associations of OKS and satisfaction with 6 variables (age, sex, body mass index (BMI), preoperative hip knee ankle (HKA) angle, preoperative OKS, alignment technique). Results. The iKA and aMA techniques yielded comparable outcome scores (p=0.069), with OKS respectively 44.6±3.5 and 42.2±6.3. VAS Satisfaction was better (p=0.012) with iKA (9.2±0.8) compared to aMA (8.5±1.3). The number of patients that achieved OKS and satisfaction PASS thresholds was significantly higher (p=0.049 and p=0.003, respectively) using iKA (98% and 80%) compared to aMA (85% and 48%). Knees with preoperative varus deformity, achieved significantly (p=0.025) better OKS using iKA (45.4±2.0) compared to aMA (41.4±6.8). Multivariable analyses confirmed better OKS (β=3.1; p=0.007) and satisfaction (β=0.73; p=0.005) with iKA. Conclusions. The results of this study suggest that iKA and aMA grant comparable clinical outcomes at 12-months follow-up, though a greater proportion of knees operated by iKA achieved the PASS thresholds for OKS and satisfaction. Notably. in knees with preoperative varus deformity, iKA yielded significantly better OKS and satisfaction than aMA


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 507 - 514
1 Mar 2021
Chang JS Kayani B Wallace C Haddad FS

Aims. Total knee arthroplasty (TKA) using functional alignment aims to implant the components with minimal compromise of the soft-tissue envelope by restoring the plane and obliquity of the non-arthritic joint. The objective of this study was to determine the effect of TKA with functional alignment on mediolateral soft-tissue balance as assessed using intraoperative sensor-guided technology. Methods. This prospective study included 30 consecutive patients undergoing robotic-assisted TKA using the Stryker PS Triathlon implant with functional alignment. Intraoperative soft-tissue balance was assessed using sensor-guided technology after definitive component implantation; soft-tissue balance was defined as intercompartmental pressure difference (ICPD) of < 15 psi. Medial and lateral compartment pressures were recorded at 10°, 45°, and 90° of knee flexion. This study included 18 females (60%) and 12 males (40%) with a mean age of 65.2 years (SD 9.3). Mean preoperative hip-knee-ankle deformity was 6.3° varus (SD 2.7°). Results. TKA with functional alignment achieved balanced medial and lateral compartment pressures at 10° (25.0 psi (SD 6.1) vs 23.1 psi (SD 6.7), respectively; p = 0.140), 45° (21.4 psi (SD 5.9) vs 20.6 psi (SD 5.9), respectively; p = 0.510), and 90° (21.2 psi (SD 7.1) vs 21.6 psi (SD 9.0), respectively; p = 0.800) of knee flexion. Mean ICPD was 6.1 psi (SD 4.5; 0 to 14) at 10°, 5.4 psi (SD 3.9; 0 to 12) at 45°, and 4.9 psi (SD 4.45; 0 to 15) at 90° of knee flexion. Mean postoperative limb alignment was 2.2° varus (SD 1.0°). Conclusion. TKA using the functional alignment achieves balanced mediolateral soft-tissue tension through the arc of knee flexion as assessed using intraoperative pressure-sensor technology. Further clinical trials are required to determine if TKA with functional alignment translates to improvements in patient satisfaction and outcomes compared to conventional alignment techniques. Cite this article: Bone Joint J 2021;103-B(3):507–514


The Bone & Joint Journal
Vol. 102-B, Issue 6 Supple A | Pages 79 - 84
1 Jun 2020
Abdelfadeel W Houston N Star A Saxena A Hozack WJ

Aims. The aim of this study was to analyze the true costs associated with preoperative CT scans performed for robotic-assisted total knee arthroplasty (RATKA) planning and to determine the value of a formal radiologist’s report of these studies. Methods. We reviewed 194 CT reports of 176 sequential patients who underwent primary RATKA by a single surgeon at a suburban teaching hospital. CT radiology reports were reviewed for the presence of incidental findings that might change the management of the patient. Payments for the scans, including the technical and professional components, for 330 patients at two hospitals were also recorded and compared. Results. There were 82 incidental findings in 61 CT studies, one of which led to a recommendation for additional testing. Across both institutions, the mean total payment for a preoperative scan was $446 ($8 to $3,870). The mean patient payment was $71 ($0 to $2,690). There was wide variation in payments between the institutions. In Institution A, the mean total payment was $258 ($168 to $264), with a mean patient payment of $57 ($0 to $100). The mean technical payment in this institution was $211 ($8 to $856), while the mean professional payment was $48 ($0 to $66). In Institution B, the mean total payment was $636 ($37 to $3,870), with a mean patient payment of $85 ($0 to $2,690). Conclusion. The total cost of a CT scan is low and a minimal part of the overall cost of the RATKA. No incidental findings identified on imaging led to a change in management, suggesting that the professional component could be eliminated to reduce costs. Further studies need to take into account the patient perspective and the wide variation in total costs and patient payments across institutions and insurances. Cite this article: Bone Joint J 2020;102-B(6 Supple A):79–84


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 78 - 78
23 Feb 2023
Bolam S Tay M Zaidi F Sidaginamale R Hanlon M Munro J Monk A
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The introduction of robotics for total knee arthroplasty (TKA) into the operating theatre is often associated with a learning curve and is potentially associated with additional complications. The purpose of this study was to determine the learning curve of robotic-assisted (RA) TKA within a multi-surgeon team. This prospective cohort study included 83 consecutive conventional jig-based TKAs compared with 53 RA TKAs using the Robotic Surgical Assistant (ROSA) system (Zimmer Biomet, Warsaw, Indiana, USA) for knee osteoarthritis performed by three high-volume (> 100 TKA per year) orthopaedic surgeons. Baseline characteristics including age, BMI, sex and pre-operative Kellgren-Lawrence grade were well-matched between the conventional and RA TKA groups. Cumulative summation (CUSUM) analysis was used to assess learning curves for operative times for each surgeon. Peri-operative and delayed complications were reviewed. The CUSUM analysis for operative time demonstrated an inflexion point after 5, 6 and 15 cases for each of the three surgeons, or 8.7 cases on average. There were no significant differences (p = 0.53) in operative times between the RA TKA learning (before inflexion point) and proficiency (after inflexion point) phases. Similarly, the operative times of the RA TKA group did not differ significantly (p = 0.92) from the conventional TKA group. There was no discernible learning curve for the accuracy of component planning using the RA TKA system. The average length of post-operative follow-up was 21.3 ± 9.0 months. There was no significant difference (p > 0.99) in post-operative complication rates between the groups. The introduction of the RA TKA system was associated with a learning curve for operative time of 8.7 cases. Operative times between the RA TKA and conventional TKA group were similar. The short learning curve implies this RA TKA system can be adopted relatively quickly into a surgical team with minimal risks to patients


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 22 - 22
1 Feb 2020
Lawrence J Keggi J Randall A DeClaire J Ponder C Koenig J Shalhoub S Wakelin E Plaskos C
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Introduction. Soft-tissue balancing methods in TKA have evolved from surgeon feel to digital load-sensing tools. Such techniques allow surgeons to assess the soft-tissue envelope after bone cuts, however, these approaches are ‘after-the-fact’ and require soft-tissue release or bony re-cuts to achieve final balance. Recently, a robotic ligament tensioning device has been deployed which characterizes the soft tissue envelope through a continuous range-of-motion after just the initial tibial cut, allowing for virtual femoral resection planning to achieve a targeted gap profile throughout the range of flexion (figure-1). This study reports the first early clinical results and patient reported outcomes (PROMs) associated with this new technique and compares the outcomes with registry data. Methods. Since November 2017, 314 patients were prospectively enrolled and underwent robotic-assisted TKA using this surgical technique (mean age: 66.2 ±8.1; females: 173; BMI: 31.4±5.3). KOOS/WOMAC, UCLA, and HSS-Patient Satisfaction scores were collected pre- and post-operatively. Three, six, and twelve-month assessments were completed by 202, 141, and 63 patients, respectively, and compared to registry data from the Shared Ortech Aggregated Repository (SOAR). SOAR is a TJA PROM repository run by Ortech, an independent clinical data collection entity, and it includes data from thousands of TKAs from a diverse cross-section of participating hospitals, teaching institutions and clinics across the United States and Canada who collect outcomes data. PROMs were compared using a two-tailed t-test for non-equal variance. Results. When comparing the baseline PROM scores, robotic patients had equivalent womac knee stiffness (p=0.58) and UCLA activity scale (p=0.38) scores but slightly higher womac knee pain (p=0.002) and functional scores (p=0.014, figure-2). While all scores improved over time, the rate of improvement was generally greater at 6 months than at three months when comparing the two groups, with statistically higher six-month scores in the robotic group for all categories (p<0.001). Overall patient satisfaction in the RB cohort was 90.3%, 95.0% and 91.8% at 3M, 6M and 1Y, respectively (figure-3). Average length of hospital stay was 1.6 days (±0.8). Surgical complications in this cohort included one infection four months post-op, 6 post-operative knee manipulations, one pulmonary embolism and one wound dehiscence from a fall. Discussion. We postulated that the ability to use gap data prospectively under known loading conditions throughout the knee range-of-motion would allow femoral cut planning that resulted in optimum balance with fewer releases and better long-term results. While the study group patients had slightly higher baseline knee pain and function than registry patients and showed similar net improvements at the three-month mark, study patients showed significantly better improvements in all areas between three months and six months compared to registry data. WOMAC stiffness and UCLA activity scores were equal between the two groups at baseline and significantly improved at three months and six months. Better ligament balance may have significantly contributed to these gains and to the high rates of satisfaction reported in the study patients compared to the historical literature. Limitations to this study include the small number of patients and the lack of a closely matched control group. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 9 - 9
1 Feb 2020
Stulberg B Zadzilka J Kreuzer S Long W Kissin Y Liebelt R Campanelli V Zuhars J
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Introduction. Active robotics for total knee Arthroplasty (TKA) uses a CAD-CAM approach to plan the correct size and placement of implants and to surgically achieve planned limb alignment. The TSolution One Total Knee Application (THINK Surgical Inc., Fremont, CA) is an open-implant platform, CT-based active robotic surgical system. A multi-center, prospective, non-randomized clinical trial was performed to evaluate safety and effectiveness of robotic-assisted TKA using the TSolution One Total Knee Application. This report details the findings from the IDE. Methods. Patients had to be ≥ 21 years old with BMI ≤ 40, Kellgren-Lawrence Grade ≥ 3, coronal deformity ≤ 20°, and sagital flexion contracture ≤ 15° to participate. In addition to monitoring all adverse events (AE), a pre-defined list of relevant major AEs (medial collateral ligament injury, extensor mechanism disruption, neural deficit, periprosthetic fracture, patellofemoral dislocation, tibiofemoral dislocation, vascular injury) were specifically identified to evaluate safety. Bleeding complications were also assessed. Malalignment rate, defined as the percentage of patients with more than a ± 3° difference in varus-valgus alignment from the preoperative plan, was used to determine accuracy of the active robotic system. Knee Society Scores (KSS) and Short Form 12 (SF-12) Health Surveys were assessed as clinical outcome measures. Results were compared to published values associated with manual TKA. Results. A total of 115 patients were enrolled at 6 US centers and followed for a maximum of 12 months after surgery. Mean surgical time (incision to close) improved consistently as the technique evolved (first 10 cases = 131.5 min, first 20 cases = 122.4 min), with mean robot time = 45.8 min. The incidence of pre-defined AEs identified was 0%, serving as a measure of safety of the procedure. Outside of the pre-defined list, only one AE was definitely associated with the use of the device; a metal tack was left inside the knee joint but no reoperation was performed. No patients required a blood transfusion. Alignment outside of the ± 3° goal was 11.2% with a difference of 0.5° ± 1.9° (mean ± STD), which represents a 43% statistically significant (posterior probability > 0.95) reduction in malalignment compared to the literature. Mean KSS Functional scores improved from 40.2 at baseline to 65.4 at 3 months, mean KSS Objective scores improved from 46.9 to 71.2, mean KSS Patient Satisfaction scores improved from 14.5 to 30.6, and mean SF-12 Physical Component scores improved from 32.9 to 43.5. Discussion. The TSolution One Total Knee Application is descended from an active robotic system used in >8000 cases outside the United States since 2002. This trial represents the first US based study of this technology for primary TKA. The clinical study demonstrated positive safety outcomes as none of the seven pre-defined AEs were observed and there were no cases requiring transfusion. A positive effectiveness outcome was also demonstrated as the malalignment rate found in this study showed a substantial reduction from the 32% malalignment rate published in the literature for conventional instruments. KSS and SF-12 scores were comparable to other published TKA series. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 49 - 49
1 Feb 2020
Gustke K Morrison T
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Introduction. In total knee arthroplasty (TKA), component realignment with bone-based surgical correction (BBSC) can provide soft tissue balance and avoid the unpredictability of soft tissue releases (STR) and potential for more post-operative pain. Robotic-assisted TKA enhances the ability to accurately control bone resection and implant position. The purpose of this study was to identify preoperative and intraoperative predictors for soft tissue release where maximum use of component realignment was desired. Methods. This was a retrospective, single center study comparing 125 robotic-assisted TKAs quantitatively balanced using load-sensing tibial trial components with BBSC and/or STR. A surgical algorithm favoring BBSC with a desired final mechanical alignment of between 3° varus and 2° valgus was utilized. Component realignment adjustments were made during preoperative planning, after varus/valgus stress gaps were assessed after removal of medial and lateral osteophytes (pose capture), and after trialing. STR was performed when a BBSC would not result in knee balance within acceptable alignment parameters. The predictability for STR was assessed at four steps of the procedure: Preoperatively with radiographic analysis, and after assessing static alignment after medial and lateral osteophyte removal, pose capture, and trialing. Cutoff values predictive of release were obtained using receiver operative curve analysis. Results. STR was necessary in 43.5% of cases with medial collateral ligament (MCL) release being the most common. On preoperative radiographs, a medial tibiofemoral angle (mTFA) ≤177° predicted MCL release (AUC = 0.76. p< 0.01) while an mTFA ≥188° predicted ITB release (AUC = 0.79, p <0.01). Intraoperatively after removal of osteophytes, a robotically assessed mechanical alignment (MA) ≥8° varus predicted MCL release (AUC = 0.84. p< 0.01) while a MA ≥2° valgus (AUC = 0.89, p< 0.01) predicted ITB release. During pose-capture, in medially tight knees, an extension gap imbalance ≥2.5mm (AUC = 0.82, p <0.01) and a flexion gap imbalance ≥2.0mm (AUC = 0.78, p <0.01) predicted MCL release while in laterally tight knees, any extension or flexion gap imbalance >0 mm predicted ITB release (AUC = 0.84, p <0.01 and AUC = 0.82, p <0.01 respectively). During trialing, in medially tight knees, a medial>lateral extension load imbalance ≥18 PSI (AUC = 0.84. p< 0.01) and a flexion load imbalance ≥ 35 PSI (AUC = 0.83, p< 0.01) predicted MCL release while, in laterally tight knees, a lateral>medial extension load imbalance ≥3 PSI (AUC = 0.97, p< 0.01) or flexion load imbalance ≥ 9.5 PSI (AUC = 0.86, p< 0.01) predicted ITB release. Of all identified predictors, load imbalance at trialing had the greatest positive predictive value for STR. Conclusion. There are limitations to the extent that TKA imbalance that can be corrected with BBSC alone if one has a range of acceptable alignment parameters. The ability to predict STR improves from pose-capture to trialing stages during detection of load imbalance. Perhaps this may be due to posterior osteophytes that are still present at pose capture. Further investigation of the relationship between the presence, location and size of posterior osteophytes and need for STR during TKA is necessary


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 10 - 10
1 Oct 2019
Stulberg BN Zadzilka JD Kreuzer S Long WJ Kissin YD Liebelt RA Campanelli V Zuhars J
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Introduction. Active robotics for total knee Arthroplasty (TKA) uses a CAD-CAM approach to plan the correct size and placement of implants and to surgically achieve planned limb alignment. The TSolution One Total Knee Application (THINK Surgical Inc., Fremont, CA) is an open-implant platform, CT-based active robotic surgical system. A multi-center, prospective, non-randomized clinical trial was performed to evaluate the safety and effectiveness of robotic-assisted TKA using the TSolution One Total Knee Application. This report details the findings from the IDE. Methods. Inclusion criteria for patients receiving robotic TKA were: primary unilateral TKA; Kellgren-Lawrence OA grade 3 or 4; BMI < 40 kg/m2; coronal plane deformity < 20° varus; sagittal flexion contracture < 15°. In addition to monitoring all adverse events (AE), a pre-defined list of relevant major AEs were specifically identified to evaluate safety (Healy et al, 2013): medial collateral ligament injury; extensor mechanism disruption; neural deficit; periprosthetic fracture; patellofemoral dislocation; tibiofemoral dislocation; and vascular injury. Bleeding complications were also assessed. Malalignment rate, defined as the percentage of patients with more than a ± 3° difference in varus-valgus alignment from the preoperative plan, was used to determine accuracy of the active robotic system. Knee Society Scores (KSS) and Short Form 12 (SF-12) Health Surveys were assessed as clinical outcome measures. For each outcome, results were compared to published values associated with manual TKA. Results. A total of 115 patients were enrolled at 6 US centers and followed for a maximum of 12 months after surgery. Mean surgical time (incision to close) improved consistently as the technique evolved (first 10 cases = 131.5 min, first 20 cases = 122.4 min), with mean robot time = 45.8 min. The incidence of pre-defined AEs identified was 0%, serving as a measure of safety of the procedure. Outside of the pre-defined list, only one AE was definitely associated with the use of the device; a metal pin was left inside the knee joint but no reoperation was performed. No patients required a blood transfusion. Alignment outside of the ± 3° goal was 11.2% with a difference of 0.5° ± 1.9° (mean ± STD), which represents a 45% statistically significant (posterior probability > 0.95) reduction in malalignment compared to the literature (Mason et al, 2007). Mean KSS Functional scores improved from 40.5 at baseline to 65.3 at 3 months, mean KSS Objective scores improved from 36.8 to 81.0, mean KSS Patient Satisfaction scores improved from 14.4 to 30.6, and mean SF-12 Physical Component scores improved from 32.9 to 43.5. Discussion. The TSolution One Total Knee Application is descended from an active robotic system used in >8000 cases outside the United States since 2002. This trial represents the first US based study of this technology for primary TKA. The clinical study demonstrated positive safety outcomes as none of the seven pre-defined AEs were observed and there were no cases requiring transfusion. A positive effectiveness outcome was also demonstrated as the malalignment rate found in this study showed a substantial reduction from the 32% malalignment rate published in the literature for conventional instruments. KSS and SF-12 scores were comparable to other published TKA series. For figures, tables, or references, please contact authors directly


Background. There are limited previous findings detailed biomechanical properties following implantation with mechanical and kinematic alignment method in robotic total knee arthroplasty (TKA) during walking. The purpose of this study was to compare clinical and radiological outcomes between two groups and gait analysis of kinematic, and kinetic parameters during walking to identify difference between two alignment method in robotic total knee arthroplasty. Methods. Sixty patients were randomly assigned to undergo robotic-assisted TKA using either the mechanical (30 patients) or the kinematic (30 patients) alignment method. Clinical outcomes including varus and valgus laxities, ROM, HSS, KSS and WOMAC scores and radiological outcomes were evaluated. And ten age and gender matched patients of each group underwent gait analysis (Optic gait analysis system composed with 12 camera system and four force plate integrated) at minimum 5 years post-surgery. We evaluated parameters including knee varus moment and knee varus force, and find out the difference between two groups. Results. The mean follow up duration of both group was 8.1 years (mechanical method) and 8.0 years (kinematic method). Clinical outcome between two groups showed no significant difference in ROM, HSS, WOMAC, KSS pain score at last follow up. Varus and valgus laxity assessments showed no significant inter-group difference. We could not find any significant difference in mechanical alignment of the lower limb and perioperative complicatoin. In gait analysis, no significant spatiotemporal, kinematic or kinetic parameter differences including knee varus moment (mechanical=0.33, kinematic=0.16 P0.5) and knee varus force (mechanical=0.34, kinematic=0.37 P0.5) were observed between mechanical and kinematic groups. Conclusions. The results of this study show that mechanical and kinematic alignment method provide comparable clinical and radiological outcomes after robotic total knee arthroplasty in average 8 years follow-up. And no functional difference were found between two knee alignment methods during walking


Background. There are limited previous findings detailed biomechanical properties following implantation with mechanical and kinematic alignment method in robotic total knee arthroplasty (TKA) during walking. The purpose of this study was to compare clinical and radiological outcomes between two groups and gait analysis of kinematic, and kinetic parameters during walking to identify difference between two alignment method in robotic total knee arthroplasty. Methods. Sixty patients were randomly assigned to undergo robotic-assisted TKA using either the mechanical (30 patients) or the kinematic (30 patients) alignment method. Clinical outcomes including varus and valgus laxities, ROM, HSS, KSS and WOMAC scores and radiological outcomes were evaluated. And ten age and gender matched patients of each group underwent gait analysis (Optic gait analysis system composed with 12 camera system and four force plate integrated) at minimum 5 years post-surgery. We evaluated parameters including knee varus moment and knee varus force, and find out the difference between two groups. Results. The mean follow up duration of both groups was 8.1 years (mechanical method) and 8.0 years (kinematic method). Clinical outcome between two groups showed no significant difference in ROM, HSS, WOMAC, KSS pain score at last follow up. Varus and valgus laxity assessments showed no significant inter-group difference. We could not find any significant difference in mechanical alignment of the lower limb and perioperative complicatoin. In gait analysis, no significant spatiotemporal, kinematic or kinetic parameter differences including knee varus moment (mechanical=0.33, kinematic=0.16 P0.5) and knee varus force (mechanical=0.34, kinematic=0.37 P0.5) were observed between mechanical and kinematic groups. Conclusions. The results of this study show that mechanical and kinematic alignment method provide comparable clinical and radiological outcomes after robotic total knee arthroplasty in average 8 years follow-up. And no functional differences were found between two knee alignment methods during walking


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 91 - 91
1 May 2016
Conditt M Gustke K Coon T Kreuzer S Branch S Bhowmik-Stoker M D'Alessio J Otto J Abassi A
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Introduction. Preoperative templating of femoral and tibial components can assist in choosing the appropriate implant size prior to TKA. While weight bearing long limb roentograms have been shown to provide benefit to the surgeon in assessing alignment, disease state, and previous pathology or trauma, their accuracy in size prediction is continually debated due to scaling factors and rotated views. Further, they represent a static time point, accounting for boney anatomy only. A perceived benefit of robotic-assisted surgery is the ability to pre-operatively select component sizes with greater accuracy based on 3D information, however, to allow for flexibility in refining based on additional data only available at the time of surgery. Methods. The purpose of this study was to determine the difference of pre-operative plans in size prediction of the tibia, femur, and polyethylene insert. Eighty four cases were enrolled at three centers as part of an Investigational Device Exemption to evaluate a robotic-assisted TKA. All patients had a CT scan as part of a pre-operative planning protocol. Scans were segmented and implant sizes predicted based on the patients boney morphology and an estimated 2mm cartilage presence. Additional information such as actual cartilage presence and soft tissue effects on balance and kinematics were recorded intra-operatively. Utilizing this additional information, surgical plans were fine tuned if necessary to achieve minimal insert thickness and balance. Data from the Preoperative CT plan sizing and final size were compared to determine the percentage of size and within one size accuracy. Results. The pre-operative plan was able to determine the femoral and tibial components within one size for 100% of cases. Intra-operatively, surgeon upsized femoral 15 out of 85 (18%), downsized femoral 1 out of 85 (1%), baseplate 13 out of 85 (15%), and downsized baseplate 4 out of 85 (5%). Polyethylene exact size could be planned 93% of the time. Discussion/Conclusion. Robotic-assisted pre-operative CT based planning was accurate over 70% of the time for the femur and tibial components, and over 90% with respect to the insert thickness Additionally, intraoperative information allowed for adjustments to provide patients with ideal coverage of articular surfaces and for joint balancing providing optimal individualized component placement. Further research is needed to determine the potential cost savings in hospital and OR inventory management


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 961 - 970
1 Sep 2023
Clement ND Galloway S Baron YJ Smith K Weir DJ Deehan DJ

Aims

The primary aim was to assess whether robotic total knee arthroplasty (rTKA) had a greater early knee-specific outcome when compared to manual TKA (mTKA). Secondary aims were to assess whether rTKA was associated with improved expectation fulfilment, health-related quality of life (HRQoL), and patient satisfaction when compared to mTKA.

Methods

A randomized controlled trial was undertaken, and patients were randomized to either mTKA or rTKA. The primary objective was functional improvement at six months. Overall, 100 patients were randomized, 50 to each group, of whom 46 rTKA and 41 mTKA patients were available for review at six months following surgery. There were no differences between the two groups.


Bone & Joint 360
Vol. 12, Issue 2 | Pages 16 - 19
1 Apr 2023

The April 2023 Knee Roundup360 looks at: Does bariatric surgery reduce complications after total knee arthroplasty?; Mid-flexion stability in total knee arthroplasties implanted with kinematic alignment: posterior-stabilized versus medial-stabilized implants; Inflammatory response in robotic-arm-assisted versus conventional jig-based total knee arthroplasty; Journey II bicruciate stabilized (JII-BCS) and GENESIS II total knee arthroplasty: the CAPAbility, blinded, randomized controlled trial; Lifetime risk of revision and patient factors; Platelet-rich plasma use for hip and knee osteoarthritis in the USA; Where have the knee revisions gone?; Tibial component rotation in total knee arthroplasty: CT-based study of 1,351 tibiae.