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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


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


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


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


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_9 | Pages 28 - 28
1 Oct 2020
Deckey DG Rosenow CS Verhey JT Mayfield CK Christopher ZK Clarke HD Bingham JS
Full Access

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. 100-B, Issue SUPP_12 | Pages 71 - 71
1 Oct 2018
Cool CL Mont MA Jacofsky DJ
Full Access

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. 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
Full Access

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


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. 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


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 Open
Vol. 5, Issue 8 | Pages 681 - 687
19 Aug 2024
van de Graaf VA Shen TS Wood JA Chen DB MacDessi SJ

Aims

Sagittal plane imbalance (SPI), or asymmetry between extension and flexion gaps, is an important issue in total knee arthroplasty (TKA). The purpose of this study was to compare SPI between kinematic alignment (KA), mechanical alignment (MA), and functional alignment (FA) strategies.

Methods

In 137 robotic-assisted TKAs, extension and flexion stressed gap laxities and bone resections were measured. The primary outcome was the proportion and magnitude of medial and lateral SPI (gap differential > 2.0 mm) for KA, MA, and FA. Secondary outcomes were the proportion of knees with severe (> 4.0 mm) SPI, and resection thicknesses for each technique, with KA as reference.


Bone & Joint Open
Vol. 2, Issue 11 | Pages 974 - 980
25 Nov 2021
Allom RJ Wood JA Chen DB MacDessi SJ

Aims

It is unknown whether gap laxities measured in robotic arm-assisted total knee arthroplasty (TKA) correlate to load sensor measurements. The aim of this study was to determine whether symmetry of the maximum medial and lateral gaps in extension and flexion was predictive of knee balance in extension and flexion respectively using different maximum thresholds of intercompartmental load difference (ICLD) to define balance.

Methods

A prospective cohort study of 165 patients undergoing functionally-aligned TKA was performed (176 TKAs). With trial components in situ, medial and lateral extension and flexion gaps were measured using robotic navigation while applying valgus and varus forces. The ICLD between medial and lateral compartments was measured in extension and flexion with the load sensor. The null hypothesis was that stressed gap symmetry would not correlate directly with sensor-defined soft tissue balance.


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 67 - 73
1 Jun 2021
Lee G Wakelin E Randall A Plaskos C

Aims

Neither a surgeon’s intraoperative impression nor the parameters of computer navigation have been shown to be predictive of the outcomes following total knee arthroplasty (TKA). The aim of this study was to determine whether a surgeon, with robotic assistance, can predict the outcome as assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain (KPS), one year postoperatively, and establish what factors correlate with poor KOOS scores in a well-aligned and balanced TKA.

Methods

A total of 134 consecutive patients who underwent TKA using a dynamic ligament tensioning robotic system with a tibia first resection technique and a cruciate sacrificing ultracongruent TKA system were enrolled into a prospective study. Each TKA was graded based on the final mediolateral ligament balance at 10° and 90° of flexion: 1) < 1 mm difference in the thickness of the tibial insert and that which was planned (n = 75); 2) < 1 mm difference (n = 26); 3) between 1 mm to 2 mm difference (n = 26); and 4) > 2 mm difference (n = 7). The mean one-year KPS score for each grade of TKA was compared and the likelihood of achieving an KPS score of > 90 was calculated. Finally, the factors associated with lower KPS despite achieving a high-grade TKA (grade A and B) were analyzed.


Bone & Joint Open
Vol. 2, Issue 1 | Pages 48 - 57
19 Jan 2021
Asokan A Plastow R Kayani B Radhakrishnan GT Magan AA Haddad FS

Cementless knee arthroplasty has seen a recent resurgence in popularity due to conceptual advantages, including improved osseointegration providing biological fixation, increased surgical efficiency, and reduced systemic complications associated with cement impaction and wear from cement debris. Increasingly younger and higher demand patients are requiring knee arthroplasty, and as such, there is optimism cementless fixation may improve implant survivorship and functional outcomes.

Compared to cemented implants, the National Joint Registry (NJR) currently reports higher revision rates in cementless total knee arthroplasty (TKA), but lower in unicompartmental knee arthroplasty (UKA). However, recent studies are beginning to show excellent outcomes with cementless implants, particularly with UKA which has shown superior performance to cemented varieties. Cementless TKA has yet to show long-term benefit, and currently performs equivalently to cemented in short- to medium-term cohort studies. However, with novel concepts including 3D-printed coatings, robotic-assisted surgery, radiostereometric analysis, and kinematic or functional knee alignment principles, it is hoped they may help improve the outcomes of cementless TKA in the long-term. In addition, though cementless implant costs remain higher due to novel implant coatings, it is speculated cost-effectiveness can be achieved through greater surgical efficiency and potential reduction in revision costs. There is paucity of level one data on long-term outcomes between fixation methods and the cost-effectiveness of modern cementless knee arthroplasty.

This review explores recent literature on cementless knee arthroplasty, with regards to clinical outcomes, implant survivorship, complications, and cost-effectiveness; providing a concise update to assist clinicians on implant choice.

Cite this article: Bone Jt Open 2021;2(1):48–57.