Alignment is only part of the equation: High variability in soft tissue distractibility in the varus knee undergoing primary TKA.

PURPOSE: The purpose of this study is to evaluate the in vivo medial and lateral joint laxities across various total knee arthroplasty (TKA) alignment categories correlated to (1) hip-knee-ankle angle, (2) proximal tibial angle and (3) distal femoral angle in a consecutive group of patients undergoing robotic-assisted TKA. METHODS: Using ligament tensions acquired during 805 robotic-assisted TKA with a dynamic ligament tensor under a load of 70-90 N, the relationship between medial and lateral collateral ligament laxity and overall limb alignment was established. Only knees with neutral or mechanical varus alignment were included and divided into five groups: neutral (0°-3°), varus 3°-5°, varus 6°-9°, varus 10°-13° and varus ≥14°. Groups were further subdivided by the intraoperative medial proximal tibial angle (MPTA) and lateral distal femoral angle (LDFA). The distraction of the medial and lateral sides was compared across the various alignments using an analysis of variance. RESULTS: The ability to distract the medial collateral ligament in extension and flexion was proportional to the degree of varus deformity, increasing from 4.0 ± 2.3 mm in the neutral group to 8.7 ± 3.2 mm in the varus ≥14° group (p < 0.0001). On the lateral side, the distraction of the lateral collateral ligament decreased in both extension (2.2 ± 2.4 vs. 1.2 ± 2.7, p < 0.0001) and flexion (2.8 ± 2.8 to 1.7 ± 3.0, p < 0.0001) with increasing native varus deformity. MPTA and LDFA had similar effects, where increasing MPTA varus and LDFA valgus increased medial distractibility in extension and flexion. There was significant variability of the stretch of the ligaments within and across all alignment categories, in which the standard deviation of the groups ranged from 2.0 to 3.0 mm. CONCLUSION: This study demonstrates increased medial ligament distractibility with increasing varus deformity. However, there was significant variability in ligamentous laxity within various limb alignment categories suggesting the anatomy and soft tissue identity of the knee is complex and highly variable. TKAs seeking to be more anatomic will not only need to restore alignment but also native soft tissue tensions. LEVEL OF EVIDENCE: Level III, prognostic.

Excessive posterior pelvic tilt from preoperative supine to postoperative standing after total hip arthroplasty.

Aims: Excessive posterior pelvic tilt (PT) may increase the risk of anterior instability after total hip arthroplasty (THA). The aim of this study was to investigate the changes in PT occurring from the preoperative supine to postoperative standing position following THA, and identify factors associated with significant changes in PT. Methods: Supine PT was measured on preoperative CT scans and standing PT was measured on preoperative and one-year postoperative standing lateral radiographs in 933 patients who underwent primary THA. Negative values indicate posterior PT. Patients with > 13° of posterior PT from preoperative supine to postoperative standing (ΔPT ≤ -13°) radiographs, which corresponds to approximately a 10° increase in functional anteversion of the acetabular component, were compared with patients with less change (ΔPT > -13°). Logistic regression analysis was used to assess preoperative demographic and spinopelvic parameters predictive of PT changes of ≤ -13°. The area under receiver operating characteristic curve (AUC) determined the diagnostic accuracy of the predictive factors. Results: PT changed from a mean of 3.8° (SD 6.0°)) preoperatively to -3.5° (SD 6.9°) postoperatively, a mean change of -7.4 (SD 4.5°; p < 0.001). A total of 95 patients (10.2%) had ≤ -13° change in PT from preoperative supine to postoperative standing. The strongest predictive preoperative factors of large changes in PT (≤ -13°) from preoperative supine to postoperative standing were a large posterior change in PT from supine to standing, increased supine PT, and decreased standing PT (p < 0.001). Flexed-seated PT (p = 0.006) and female sex (p = 0.045) were weaker significant predictive factors. When including all predictive factors, the accuracy of the AUC prediction was 84.9%, with 83.5% sensitivity and 71.2% specificity. Conclusion: A total of 10% of patients had > 13° of posterior PT postoperatively compared with their supine pelvic position, resulting in an increased functional anteversion of > 10°. The strongest predictive factors of changes in postoperative PT were the preoperative supine-to-standing differences, the anterior supine PT, and the posterior standing PT. Surgeons who introduce the acetabular component with the patient supine using an anterior approach should be aware of the potentially large increase in functional anteversion occurring in these patients.

Modern robotics platform associated with reduced 90-day complications in hospital setting.

BACKGROUND: Early complications in total knee arthroplasty (TKA) associated with modern robotics platforms integrated with digital balancing technology have not been investigated. OBJECTIVE: The objective was to compare 90-day complication rates between a manual technique and a modern robotic-assisted ligament balancing TKA platform. METHODS: 895 primary TKA procedures from a single surgeon were retrospectively reviewed (614 manual TKA, 281 using a modern robotics platform with an integrated digitally controlled ligament balancing device). Post-operative complications within the 90-day episode of care were recorded by the Michigan Arthroplasty Registry Collaborative Quality Initiative. Differences in complication rates between techniques were further divided into inpatient hospital, outpatient hospital, and ambulatory surgery center (ASC) cohorts. RESULTS: In the pooled hospital cohort and inpatient hospital cohort, 'Return to OR' was significantly lower for the robotic assisted group (1.3% vs 5.2% and 0% vs 4.9%, respectively, p< 0.0370). Specifically, the need for manipulation under anesthesia (MUA) was reduced for the robotics group (0.0% vs 2.5%, p= 0.0352). No differences in overall complication rate or cause of complication was found between manual and robotics cases for the hospital outpatient and ASC cohorts (p⩾ 0.68). CONCLUSION: Within the hospital setting, robotic assisted ligament balancing technology was associated with reduced 90-day postoperative complications for 'Return to OR' and MUA.

Patient reported outcome measures correlate with step-count in total hip arthroplasty.

BACKGROUND: Passive smartphone-based apps are becoming more common for measuring patient progress after total hip arthroplasty (THA). Optimum activity levels during early THA recovery have not been well documented. OBJECTIVES: Correlations between step-count and patient reported outcome measures (PROMs) during early recovery were explored. This study also investigated how demographics impact step-count during early post-operative recovery. METHODS: Smartphone captured step-count data from 666 THA patients was retrospectively reviewed. Mean age was 64 ± 11 years. 55% were female. Mean BMI was 29 ± 8kg/m2. Mean daily step-count was calculated for each patient over four time-windows: 60 days prior to surgery (preop), 42-49 days postop (6 weeks), 91-98 days postop (3 months), and 183-197 days postop (6 months). Spearman correlation coefficients and linear regression were used to assess the association between PROMs (HOOS-12, HOOS-Jr, and UCLA) were performed. Patients were separated into three step-count levels: low (< 2500 steps/day), medium (2500-5500 steps/day), and high (> 5500 steps/day). Age > 65 years, BMI > 35 kg/m2, and sex were used for demographic comparisons. Post hoc analyses were performed using Welch's unequal variances t-tests, or Wilcoxon rank-sum tests, both with Bonferroni corrections, where appropriate when comparing between groups. Chi-squared analyses were also used when comparing categorical variables. RESULTS: UCLA correlated with step-count at all time-windows (p< 0.001). HOOS12-Function correlated with step-count preoperatively, at 6 weeks, and at 3 months (p< 0.001). High step-count individuals had improved UCLA scores compared to low step-count individuals preoperatively (Δ1.5, p< 0.001), at 6 weeks (Δ0.9, p< 0.001), at 3 months (Δ1.4, p< 0.001), and at 6 months (Δ1.4, p< 0.001). High step-count individuals had improved HOOS12-Function scores compared to low step-count individuals preoperatively (Δ9.6, p< 0.001), at 6 weeks (Δ5.3, p< 0.001), and at 3 months (Δ6.1, p< 0.001). Males had greater step-count at all time points (p< 0.001). Younger patients and low BMI patients had greater step-count across all time points (p< 0.001). CONCLUSION: High step-count improved PROMs scores compared to low step-count. Early post-operative step-count was significantly impacted by age, sex, and BMI. Generic recovery profiles may not be appropriate across diverse populations.

Intra-operative laxity and balance impact 2-year pain outcomes in TKA: a prospective cohort study.

PURPOSE: The objective of this study was to determine if intra-operatively measured joint gaps are associated with 2-year pain outcomes in total knee arthroplasty (TKA) and whether balance and laxity windows could be defined throughout flexion to optimize 2-year pain outcomes. Our hypothesis is that intra-operative joint gaps are associated with 2 year post-operative pain outcome. METHODS: A prospective study investigating 310 robotically assisted TKAs was performed. Final intra-operative joint gap data were recorded using a digital tensioner and component alignment data were recorded by the robotics system. Patient demographics and Knee Injury and Osteoarthritis Outcome Score (KOOS) were recorded pre-operatively and KOOS and Hospital for Special Surgery (HSS) satisfaction were recorded at 2 years post-op. A random search Simulated Annealing (SANN) optimisation algorithm was used to determine global optimum laxity and balance windows at different flexion angles which maximized the 2-year KOOS pain scores. The windows were combined to determine the impact of achieving optimal laxity and balance throughout flexion. To improve clinical utility, boundaries identified by the SANN algorithm were rounded to the nearest 0.5 mm before statistical analysis. RESULTS: Laxity and balance windows were defined in extension (Med lax: -2.0 to 2.5 mm, Lat lax: -0.5 to 2.5 mm, Balance: -3.0 to 0.0 mm), mid-flexion (Med lax: -1.0 to 2.5 mm, Lat lax: -0.5 to 3.0 mm, Balance: -2.0 to 2.0 mm), and flexion (Med lax: -2.0 to 3.5 mm, Lat lax: -2.0 to 1.5 mm, Balance: -3.0 to 3.0 mm). When all windows were satisfied, the greatest difference in KOOS pain score was observed (100.0 vs 94.4, p < 0.0001). The highest percentage of knees satisfying the Patient Acceptable Symptom State (PASS) for KOOS pain was also observed in knees which satisfied all windows compared to knees which did not (93% vs 71%, p = 0.0009). The proportion of knees which satisfy the PASS threshold decreased in knees which only satisfied 1-3 (29%) or 4-6 (69%) windows (p ≤ 0.0018). No optimal windows were found between component alignment and KOOS pain outcome (p ≥ 0.1180). High satisfaction was found across all groups (≥ 95%). CONCLUSION: Intra-operatively measured joint gaps are associated with all KOOS sub-score outcomes at 2 years after TKA. Optimal windows for a clinically relevant improvement in post-operative KOOS pain were defined for laxity and balance but not for alignment indicating balance may have a greater impact on outcome than alignment. LEVEL OF EVIDENCE: II.

Laxity, Balance, and Alignment of a Simulated Kinematic Alignment Total Knee Arthroplasty.

Background: Kinematic alignment (KA) and related personalized alignment strategies in total knee arthroplasty (TKA) target restoration of native joint line obliquity and alignment. In practice, deviations from exact restoration of the prearthritic joint surface are tolerated for either the femur or tibia to achieve ligamentous balance. It remains unknown what laxity, balance, and alignment would result if a pure resurfacing of both femur and tibia were performed in a KA TKA technique. Methods: We used data from 382 robot-assisted TKA performed with a digital joint tensioner to simulate TKA with a pure resurfacing KA technique for both femur and tibia. All knees had the posterior cruciate ligament retained. Knees were subdivided into 4 groups based on preoperative coronal alignment: valgus, neutral, varus, and high varus. Medial and lateral laxity in extension and flexion, balance in extension and flexion, and coronal plane alignment were compared between groups using analysis of variance testing. Results: In simulated pure resurfacing KA TKA across a range of preoperative coronal plane deformities, only 11%-31% of knees would have mediolateral extension ligament balance within ±1 mm, and 20%-41% would have a medial flexion gap that is looser than the lateral flexion gap. Over 45% of knees would have coronal hip-knee-ankle angle >3 degrees from mechanical neutral. Conclusions: In simulations of pure resurfacing KA TKA, there was wide variability in the resulting laxity and alignment outcomes. Most knees had alignment and balance outcomes outside of normally accepted ranges. Techniques that deviate from pure resurfacing in order to achieve balance appear favorable.

What is the Value of a Balanced Total Knee Arthroplasty? Getting It Right the First Time.

BACKGROUND: Instability is a leading cause of early failure following total knee arthroplasty (TKA). Enabling technologies can improve accuracy, but their clinical value remains undetermined. The purpose of this study was to determine the value of achieving a balanced knee joint at the time of TKA. METHODS: A Markov model was developed to determine the value from reduced revisions and improved outcomes associated with TKA joint balance. Patients were modeled for the first 5 years following TKA. The threshold to determine cost-effectiveness was set at an incremental cost effectiveness ratio of $50,000/quality-adjusted life year (QALY). A sensitivity analysis was performed to evaluate the influence of QALY improvement (ΔQALY) and Revision Rate Reduction on additional value generated compared to a conventional TKA cohort. The impact of each variable was evaluated by iterating over a range of ΔQALY (0 to 0.046) and Revision Rate Reduction (0% to 30%) and calculating the value generated while satisfying the incremental cost effectiveness ratio threshold. Finally, the impact of surgeon volume on these outcomes was analyzed. RESULTS: The total value of a balanced knee for the first 5 years was $8,750, $6,575, and $4,417 per case, for low, medium, and high-volume surgeons, respectively. Change in QALY accounted for greater than 90% of the value gain with a reduction in revisions making up the rest in all scenarios. The economic contribution of revision reduction was relatively constant regardless of surgeon volume ($500/case). CONCLUSION: Achieving a balanced knee had the greatest impact on ΔQALY over early revision rate. These results can help assign value to enabling technologies with joint balancing capabilities.

Variation in knee balance as a function of hip-knee-ankle angle and joint line obliquity in robotic assisted total knee arthroplasty.

PURPOSE: To describe the mediolateral (ML) gap balance in pre-resection arthritic knees undergoing robot-assisted (RA) total knee arthroplasty (TKA) within the nine phenotypes of the Coronal Plane Alignment of the Knee (CPAK) classification. METHODS: A total of 1124 RA TKA cases were retrospectively reviewed. ML balance was calculated using a digital ligament tensioning device following tibial resection and prior to any femoral resection throughout flexion (10°, 40°, and 90°). Lateral distal femoral angle (LDFA) and medial proximal tibial angle (MPTA) were landmarked intra-operatively and adjusted for wear based on hip-knee-ankle angle (HKA). Knees were then subdivided into CPAK categories based on the arithmetic HKA (aHKA) and joint line obliquity (JLO). Differences in balance between CPAK phenotypes were compared. RESULTS: For aHKA, a greater medial gap was observed in varus compared to neutral or valgus knees at 10° (5.2 ± 3.0 mm vs 3.3 ± 3.2 mm vs - 0.4 ± 5.0 mm respectively; p < 0.0001). A similar trend was observed for JLO in distal apex compared to neutral and proximal apex knees at 10° (3.4 ± 3.6 vs 1.1 ± 5.0 vs - 2.4 ± 6.3 respectively; p < 0.0001). The greatest ML balance differences were found when combining JLO and aHKA at 10° (type I vs type VI: ∆6.6 mm; p < 0.0001). CONCLUSION: There is a high degree of variability in arthritic ML balance within and between each CPAK phenotype. A single alignment philosophy based on bony landmarks alone may not be sufficient to balance all knees. Utilisation of robotics and digital ligament tensioning devices serves as important adjuncts to characterize the patient-specific soft tissue profile.

Impact of a Digital Balancing Tool on Femur and Tibial First Total Knee Arthroplasty: A Prospective Nonrandomized Controlled Trial.

Background: Recent developments in intra-operative sensor technology provide surgeons with predictive and real-time feedback on joint balance. It remains unknown, however, whether these technologies are better suited to femur-first or tibia-first workflows. This study investigates the balance accuracy, precision and early patient outcomes between the femur-first and tibial-first workflows using a digital gap-balancing tool. Methods: One-hundred six patients had posterior cruciate ligament sacrificing total knee arthroplasty using a digital joint tensioner. The participants were divided into 4 groups with different visibility to balance data 1) Femur-first blinded data, 2) Femur-first not blinded data, 3) Tibia-first blinded data, 4) Tibia-first not blinded data with predictive balancing. Knee Injury and Osteoarthritis Outcome Score and University of California at Los Angeles activity level were recorded at 1-year. Results: Group 4 reported less midflexion imbalance (40°) compared to all other groups (1: 1.5 mm, 2: 1.7 mm, 3: 1.6 mm, 4: 1.0 mm, P < .031) and reduced variance compared to all other groups at 40° and 90° (P < .012), resulting in an increased frequency of joints balanced within 2 mm throughout flexion in group 4 (1: 69%, 2: 65%, 3: 67%, 4: 91%, P < .006). No differences were found between 3-month, 6-month, or 1-year outcome scores between technique. Conclusions: Improvements in balance were observed in midflexion instability and balance variability throughout flexion when a tibia-first approach in combination with a digital balancing tool was used. The combination of a digital balancing tool and a tibia-first approach allowed a target joint balance to be achieved more accurately compared to a non-sensor augmented or femur-first approach.

Predictive Gap-balancing Reduces the Extent of Soft-tissue Adjustment Required After Bony Resection in Robot-assisted Total Knee Arthroplasty-A Comparison With Simulated Measured Resection.

Background: To understand the extent and frequency of soft-tissue adjustment required to achieve mediolateral (ML) balance in measured resection (MR) vs gap-balancing (GB) total knee arthroplasty, this study compared ML balance and joint laxity throughout flexion between the 2 techniques. The precision of predictive GB in achieving ML balance and laxity was also assessed. Methods: Two surgeons performed 95 robot-assisted GB total knee arthroplasties with predictive balancing, limiting tibial varus to 3° and adjusting femoral positioning to optimize balance. A robotic ligament tensioner measured joint laxity. Planned MR (pMR) was simulated by applying neutral tibial and femoral coronal resections and 3° of external femoral rotation. ML balance, laxity, component alignment, and resection depths were compared between planned GB (pGB) and pMR. ML balance and laxity were compared between pGB and final GB (fGB). Results: The proportion of knees with >2 mm of ML imbalance in flexion or extension ranged from 3% to 18% for pGB vs 50% to 53% for pMR (P < .001). Rates of ML imbalance >3 mm ranged from 0% to 9% for pGB and 30% to 38% for MR (P < .001). The mean pMR laxity was 1.9 mm tighter medially and 1.1 mm tighter laterally than pGB throughout flexion. The mean fGB laxity was greater than the mean pGB laxity by 0.5 mm medially and 1.2 mm laterally (P < .001). Conclusion: MR led to tighter joints than GB, with ML gap imbalances >3 mm in 30% of knees. GB planning improved ML balance throughout flexion but increased femoral posterior rotation variability and bone resection compared to MR. fGB laxity was likely not clinically significantly different than pGB.

Impact of Component Alignment and Soft Tissue Release on 2-Year Outcomes in Total Knee Arthroplasty.

BACKGROUND: The objective of this study was to investigate the impact of alignment and soft tissue release on patient outcomes following total knee arthroplasty (TKA). METHODS: In a multicenter study, soft tissue releases during TKA were prospectively documented in 330 robotic-assisted TKAs. Knee Injury and Osteoarthritis Outcome Scores (KOOS) were captured postoperatively. Delphi analysis was used to determine inlier and outlier component alignment boundaries: Tibia Coronal (TC): ±3°, Femur Coronal (FC): ±3°, Femoral Axial (FA): 3°Int-6°Ext, Hip-Knee-Ankle (HKA): 3°Val-4°Var, and Tibiofemoral Axial (TFA): 3°Int-6°Ext. Kruskal-Wallis analysis of variance tests were used to compare groups. RESULTS: No significant differences were found between any individual or grouped inlier and outlier alignment criterion and KOOS at any timepoint. Outlier alignment frequencies were: TC: 0%, FC: 12%, FA: 8%, HKA: 9%, TFA: 8%, and Any: 23%. Soft tissue releases were performed in 18% of cases. Knees with soft tissue releases reported significantly worse KOOS scores at: 6M: Symptoms (80.0 versus 75.3, P = .03), activities of daily living (ADL) (86.2 versus 80.8, P = .030), quality of life (70.1 versus 60.9, P = .008), 12M ADL (90.0 versus 85.1, P = .023), and 24M ADL (91.9 versus 87.2, P = .016). A higher proportion of patients achieved Minimal Clinically Important Difference for pain at 6 months for those having no releases versus released (92.3% versus 81.0%, P = .021). No significant associations were found between preoperative deformity and preoperative or postoperative KOOS. CONCLUSION: The addition of soft tissue releases after bony cuts is associated with worse KOOS scores out to 2 years and was more prevalent in knees with worse deformity, while no such association was found for alignment.

Restricted kinematic alignment achieves similar relative lateral laxity and greater joint line obliquity compared to gap balancing TKA.

PURPOSE: The purpose of this study was to compare ligament balance and laxity profiles achieved throughout flexion in restricted kinematic alignment (rKA) and gap balancing (GB). rKA and GB both aim to improve soft tissue balance and reduce ligament releases in total knee arthroplasty (TKA). METHODS: One surgeon performed 68 rKA, another performed 73 GB TKAs using the same CR implant and robotic system. rKA limited femoral valgus and tibial varus to 6°, with tibial recuts performed to achieve balance. GB limited tibial varus and femoral valgus to 2°, with femoral resections adjusted to achieve mediolateral balance throughout flexion using predictive-gap planning software. Final joint laxity was measured using a robotic ligament tensioner. Statistical analyses were performed to compare differences in mediolateral balance and joint laxity throughout flexion. Further analyses compared alignment, joint line elevation and orientation (JLO), and frequency of ligament releases and bone recuts. RESULTS: Both techniques reported greater lateral laxity throughout flexion, with GB reporting improved mediolateral balance from 10° to 45° flexion. GB resected 1.7 mm more distal femur (p ≤ 0.001) and had greater overall laxity than rKA throughout flexion (p ≤ 0.01). rKA increased JLO by 2.5° and 3° on the femur and tibia (p ≤ 0.001). Pre-operative and post-operative coronal alignment were similar across both techniques. rKA had a higher tibial recut rate: 26.5% vs 1.4%, p < 0.001. CONCLUSIONS: rKA and GB both report lateral laxity but with different JLO and elevation. Use of a predictive-gap GB workflow resulted in greater mediolateral gap symmetry with fewer recuts. LEVEL OF EVIDENCE: III, retrospective cohort study.

Improved total knee arthroplasty pain outcome when joint gap targets are achieved throughout flexion.

PURPOSE: Achieving a balanced knee is accepted as an important goal in total knee arthroplasty; however, the definition of ideal balance remains controversial. This study therefore endeavoured to determine: (1) whether medio-lateral gap balance in extension, midflexion, and flexion are associated with improved outcome scores at one-year post-operatively and (2) whether these relationships can be used to identify windows of optimal gap balance throughout flexion. METHODS: 135 patients were enrolled in a multicenter, multi-surgeon, prospective investigation using a robot-assisted surgical platform and posterior cruciate ligament sacrificing gap balancing technique. Joint gaps were measured under a controlled tension of 70-90 N from 10°-90° flexion. Linear correlations between joint gaps and one-year KOOS outcomes were investigated. KOOS Pain and Activities of Daily Living sub-scores were used to define clinically relevant joint gap target thresholds in extension, midflexion, and flexion. Gap thresholds were then combined to investigate the synergistic effects of satisfying multiple targets. RESULTS: Significant linear correlations were found throughout extension, midflexion, and flexion. Joint gap thresholds of an equally balanced or tighter medial compartment in extension, medial laxity ± 1 mm compared to the final insert thickness in midflexion, and a medio-lateral imbalance of less than 1.5 mm in flexion generated subgroups that reported significantly improved KOOS pain scores at one year (median ∆ = 8.3, 5.6 and 2.8 points, respectively). Combining any two targets resulted in further improved outcomes, with the greatest improvement observed when all three targets were satisfied (median ∆ = 11.2, p = 0.002). CONCLUSION: Gap thresholds identified in this study provide clinically relevant and achievable targets for optimising soft tissue balance in posterior cruciate ligament sacrificing gap balancing total knee arthroplasty. When all three balance windows were achieved, clinically meaningful pain improvement was observed. LEVEL OF EVIDENCE: Level II.

Patient expectations and satisfaction in robotic-assisted total knee arthroplasty: a prospective two-year outcome study.

INTRODUCTION: The impact of fulfillment of patient expectations throughout recovery on satisfaction in total knee arthroplasty (TKA) is not well understood. Utilizing a standardized TKA method with a robotically assisted (RA) platform, we investigated the impact of expectation fulfillment at 3-month (M) and 6-M on 1-year (Y) and 2-Y satisfaction. We hypothesize that early fulfillment of patient expectations is associated with improved midterm patient satisfaction. We also compare improvements in outcomes with RA-TKA to those of a recent large national TKA cohort study to determine whether RA-TKA meets or exceeds the current standard of care. MATERIALS AND METHODS: One hundred six patients were prospectively enrolled and underwent robotic-assisted TKA by a single surgeon using the OMNIBotics system. Patients completed KOOS and New Knee Society Score (KSS) preoperatively and at 3M, 6M, 1Y, and 2Y postoperatively. Expectation fulfillment was subdivided into patients who were below or above the average expectation score pre-operatively, or fulfillment of expectation score at 3M and 6M post TKA. The satisfaction of each group was then compared at 1Y and 2Y post TKA. Study cohort outcomes were compared to contemporary literature from the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) database. RESULTS: Patients with greater than average KSS expectation fulfillment at 3M reported significantly higher KSS satisfaction scores at 1Y (34.9 ± 5.3 vs 30.6 ± 6.7, p = 0.0012), and patients with greater than average 6M expectation fulfillment reported improved satisfaction at 1Y (33.9 ± 5.9 vs 31.1 ± 6.7, p = 0.0330) and 2Y (35.2 ± 4.8 vs 32.4 ± 6.8, p = 0.0323). When compared to the FORCE-TJR database, no significant differences in post-operative KOOS outcomes were observed except for Sports and Recreation, for which the RAS group demonstrated higher scores (65.5 ± 30.0 vs 53.0 ± 27.1 p < 0.0001); however, the study cohort reported significantly greater improvements in KOOS Pain, Symptoms, Sports and Recreation, and Quality of Life at multiple time points up to 2 years post TKA. CONCLUSION: High early-expectation fulfillment was associated with improved satisfaction at 1Y and 2Y, indicating the importance of managing patient-specific post-operative care to ensure patients reach their pre-operative goals. Greater improvements in all KOOS sub-scores and in absolute Sports and Recreation at 1Y and 2Y were observed in this robotic-assisted cohort compared to a large contemporary database, indicating that RAS meets or exceeds current standard of care benchmarks for patient-reported outcomes.

Impact of intra-operative predictive ligament balance on post-operative balance and patient outcome in TKA: a prospective multicenter study.

INTRODUCTION: New technologies exist which may assist surgeons to better predict final intra-operative joint balance. Our objectives were to compare the impact of (1) a predictive digital joint tensioning tool on intra-operative joint balance; and (2) joint balance and flexion joint laxity on patient-reported outcomes. MATERIALS AND METHODS: Two-hundred Eighty patients received posterior cruciate ligament sacrificing TKA with ultra-congruent tibial inserts using a robotic-assisted navigation platform. Patients were divided into those in which a Predictive Plan with a digital joint-tensioning device was used (PP) and those in which it was not (NPP), in all cases final post-operative joint gaps were collected immediately before final implantation. Demographics and KOOS were collected pre-operatively. KOOS, complications and satisfaction were collected at 3, 6 and 12 months post-operatively. Optimal balance difference between PP and NPP was defined and compared using area-under-the-curve analysis (AUC). Outcomes were then compared according to the results from the AUC. RESULTS: AUC analysis yielded a balance threshold of 1.5 mm, in which the PP group achieved a higher rate of balance throughout flexion compared to the NPP group: extension: 83 vs 52%; Midflexion: 82 vs 55%; Flexion 89 vs 68%; Flexion to Extension 80 vs 49%; p ≤ 0.003. Higher KOOS scores were observed in knees balanced within 1.5 mm across all sub-scores at various time points, however, differences did not exceed the minimum clinically important difference (MCID). Patients with > 1.5 mm flexion laxity medially or laterally had an increased likelihood of 2.2 (1.1-4.4) and 2.5 (1.3-4.8), respectively, for failing to achieve the Patient Acceptable Symptom State for KOOS Pain at 12 months. Patient satisfaction was high in both the PP and NPP groups (97.4 and 94.7%, respectively). CONCLUSIONS: Use of a predictive joint tensioning tool improved the final balance in TKA. Improved outcomes were found in balanced knees; however, this improvement did not achieve the MCID, suggesting further studies may be required to define optimal balance targets. Limiting medial and lateral flexion laxity resulted in an increased likelihood of achieving the Patient Acceptable Symptom State for KOOS Pain.

Clinical and Statistical Validation of a Probabilistic Prediction Tool of Total Knee Arthroplasty Outcome.

BACKGROUND: Predicting patients at risk of a poor outcome would be useful in patient selection for total knee arthroplasty (TKA). Existing models to predict outcome have seen limited functional implementation. This study aims to validate a model and shared decision-making tool for both clinical utility and predictive accuracy. METHODS: A Bayesian belief network statistical model was developed using data from the Osteoarthritis Initiative. A consecutive series of consultations for osteoarthritis before and after introduction of the tool was used to evaluate the clinical impact of the tool. A data audit of postoperative outcomes of TKA patients exposed to the tool was used to evaluate the accuracy of predictions. RESULTS: The tool changed consultation outcomes and identified patients at risk of limited improvement. After introduction of the tool, patients booked for surgery reported worse Knee Osteoarthritis and Injury Outcome Score pain scores (difference, 15.2; P < .001) than those not booked, with no significant difference prior. There was a 27% chance of not improving if predicted at risk, and a 1.4% chance if predicted to improve. This gives a risk ratio of 19× (P < .001) for patients not improving if predicted at risk. CONCLUSION: For a prediction tool to be clinically useful, it needs to provide a better understanding of the likely clinical outcome of an intervention than existed without its use when the clinical decisions are made. The tool presented here has the potential to direct patients to surgical or nonsurgical pathways on a patient-specific basis, ensuring patients who will benefit most from TKA surgery are selected.

Accurate determination of post-operative 3D component positioning in total knee arthroplasty: the AURORA protocol.

BACKGROUND: Successful component alignment is a major metric of success in total knee arthroplasty. Component translational placement, however, is less well reported despite being shown to affect patient outcomes. CT scans and planar X-rays are routinely used to report alignment but do not report measurements as precisely or accurately as modern navigation systems can deliver, or with reference to the pre-operative anatomy. METHODS: A method is presented here that utilises a CT scan obtained for pre-operative planning and a post-operative CT scan for analysis to recreate a computation model of the knee with patient-specific axes. This model is then used to determine the post-operative component position in 3D space. RESULTS: Two subjects were investigated for reproducibility producing 12 sets of results. The maximum error using this technique was 0.9° ± 0.6° in rotation and 0.5 mm ± 0.3 mm in translation. Eleven subjects were investigated for reliability producing 22 sets of results. The intra-class correlation coefficient for each of the three axes of rotation and three primary resection planes was > 0.93 indicating excellent reliability. CONCLUSIONS: Routine use of this analysis will allow surgeons and engineers to better understand the effect of component alignment as well as the placement on outcome.

Patient-Specific Simulated Dynamics After Total Knee Arthroplasty Correlate With Patient-Reported Outcomes.

BACKGROUND: Component alignment variation following total knee arthroplasty (TKA) does not fully explain the instance of long-term postoperative pain. Joint dynamics following TKA vary with component alignment and patient-specific musculoskeletal anatomy. Computational simulations allow joint dynamics outcomes to be studied across populations. This study aims to determine if simulated postoperative TKA joint dynamics correlate with patient-reported outcomes. METHODS: Landmarking and 3D registration of implants was performed on 96 segmented postoperative computed tomography scans of TKAs. A cadaver rig-validated platform for generating patient-specific simulation of deep knee bend kinematics was run for each patient. Resultant dynamic outcomes were correlated with a 12-month postoperative Knee Injury and Osteoarthritis Outcome Score (KOOS). A Classification and Regression Tree (CART) was used for determining nonlinear relationships. RESULTS: Nonlinear relationships between the KOOS pain score and rollback and dynamic coronal alignment were found to be significant. Combining a dynamic coronal angular change from extension to full flexion between 0° and 4° varus (long leg axis) and measured rollback of no more than 6 mm without rollforward formed a "kinematic safe zone" of outcomes in which the postoperative KOOS score is 10.5 points higher (P = .013). CONCLUSION: The study showed statistically significant correlations between kinematic factors in a simulation of postoperative TKA and postoperative KOOS scores. The presence of a dynamic safe zone in the data suggests a potential optimal target for any given individual patient's joint dynamics and the opportunity to preoperatively determine a patient-specific alignment target to achieve those joint dynamics.

Plasma ion implantation enabled bio-functionalization of PEEK improves osteoblastic activity.

Slow appositional growth of bone in vivo is a major problem associated with polyether ether ketone (PEEK) based orthopaedic implants. Early stage promotion of osteoblast activity, particularly bone nodule formation, would help to improve contact between PEEK implantable materials and the surrounding bone tissue. To improve interactions with bone cells, we explored here the use of plasma immersion ion implantation (PIII) treatment of PEEK to covalently immobilize biomolecules to the surface. In this study, a single step process was used to covalently immobilize tropoelastin on the surface of PIII modified PEEK through reactions with radicals generated by the treatment. Improved bioactivity was observed using the human osteoblast-like cell line, SAOS-2. Cells on surfaces that were PIII-treated or tropoelastin-coated exhibited improved attachment, spreading, proliferation, and bone nodule formation compared to cells on untreated samples. Surfaces that were both PIII-treated and tropoelastin-coated triggered the most favorable osteoblast-like responses. Surface treatment or tropoelastin coating did not alter alkaline phosphatase gene expression and activity of bound cells but did influence the expression of other bone markers including osteocalcin, osteonectin, and collagen I. We conclude that the surface modification of PEEK improves osteoblast interactions, particularly with respect to bone apposition, and enhances the orthopedic utility of PEEK.

Temperature Activated Diffusion of Radicals through Ion Implanted Polymers.

Plasma immersion ion implantation (PIII) is a promising technique for immobilizing biomolecules on the surface of polymers. Radicals generated in a subsurface layer by PIII treatment diffuse throughout the substrate, forming covalent bonds to molecules when they reach the surface. Understanding and controlling the diffusion of radicals through this layer will enable efficient optimization of this technique. We develop a model based on site to site diffusion according to Fick's second law with temperature activation according to the Arrhenius relation. Using our model, the Arrhenius exponential prefactor (for barrierless diffusion), D0, and activation energy, EA, for a radical to diffuse from one position to another are found to be 3.11 × 10(-17) m(2) s(-1) and 0.31 eV, respectively. The model fits experimental data with a high degree of accuracy and allows for accurate prediction of radical diffusion to the surface. The model makes useful predictions for the lifetime over which the surface is sufficiently active to covalently immobilize biomolecules and it can be used to determine radical fluence during biomolecule incubation for a range of storage and incubation temperatures so facilitating selection of the most appropriate parameters.