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

Wakelin, Edgar A; Ponder, Corey E; Randall, Amber L; Koenig, Jan A; Plaskos, Christopher; DeClaire, Jeffrey H; Lawrence, Jeffrey M; Keggi, John M
PURPOSE/OBJECTIVE: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/CONCLUSIONS: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/METHODS:II.
PMID: 37837574
ISSN: 1433-7347
CID: 5604602

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

Vigdorchik, Jonathan M; Wakelin, Edgar A; Koenig, Jan A; Ponder, Corey E; Plaskos, Christopher; DeClaire, Jeffrey H; Lawrence, Jeffrey M; Keggi, John M
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/CONCLUSIONS:After trying to balance the TKA with bony cuts alone, 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, whereas no such association was found for alignment.
PMID: 35533822
ISSN: 1532-8406
CID: 5288992

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

Koenig, Jan A; Wakelin, Edgar A; Passano, Brandon; Shalhoub, Sami; Plaskos, Christopher
Background/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED:< .006). No differences were found between 3-month, 6-month, or 1-year outcome scores between technique. Conclusions/UNASSIGNED: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.
PMID: 36186676
ISSN: 2352-3441
CID: 5361512

Comparison of Utilization and Short-term Complications Between Technology-assisted and Conventional Total Hip Arthroplasty

Simcox, Trevor; Singh, Vivek; Oakley, Christian T; Koenig, Jan A; Schwarzkopf, Ran; Rozell, Joshua C
INTRODUCTION/BACKGROUND:Although technology-assisted total hip arthroplasty (TA-THA) may improve implant positioning, it remains unknown whether TA-THA confers improved clinical outcomes. We sought to examine national TA-THA utilization trends and compare clinical outcomes between TA-THA and unassisted THA (U-THA). METHODS:Patients who underwent primary, elective THA from 2010 to 2018 were identified using the American College of Surgeons National Surgical Quality Improvement Program database. Demographic, perioperative, and 30-day outcomes were queried and collected. Patients were stratified based on whether they underwent TA-THA, which included computer navigation or robotics, and U-THA. Propensity score matching paired patients undergoing TA-THA or U-THA on a 1:1 basis. RESULTS:Of the 238,755 THA patients, 3,149 cases (1.3%) were done using TA-THA. Comparing the unmatched TA-THA and U-THA groups, race distribution (P < 0.001) and baseline functional status (P < 0.001) differed. Propensity score matching yielded 2,335 TA-THA and U-THA pairs. Perioperatively, the TA-THA cohort had longer mean surgical times (101.0 ± 34.0 versus 91.9 ± 38.8 minutes, P < 0.001), but lower transfusion rates (5.7% versus 7.8%, P = 0.005). As compared with the U-THA group, the TA-THA group had a shorter mean hospital length of stay (2.0 ± 1.1 versus 2.5 ± 2.0 days, P < 0.001) and a higher proportion of patients discharged home (85.8% versus 75.7%, P < 0.001). Notably, the TA-THA cohort had higher readmission rates (3.8% versus 2.4%, P < 0.001). Major complication and revision surgery rates did not markedly differ between groups. DISCUSSION/CONCLUSIONS:TA-THA utilization rates remain low among orthopaedic surgeons. As compared with U-THA, TA-THA yield mixed perioperative and 30-day outcomes. Surgeons must consider the clinical benefits and drawbacks of TA-THA when determining the proper surgical technique and technology for each patient. Clinical trials assessing long-term functional and clinical outcomes between U-THA and TA-THA are required to further elucidate the utility of assistive technologies in THA. LEVEL III EVIDENCE/UNASSIGNED:Retrospective Cohort Study.
PMID: 35139053
ISSN: 1940-5480
CID: 5156802

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

Wakelin, Edgar A; Shalhoub, Sami; Lawrence, Jeffrey M; Keggi, John M; DeClaire, Jeffrey H; Randall, Amber L; Ponder, Corey E; Koenig, Jan A; Lyman, Stephen; Plaskos, Christopher
PURPOSE/OBJECTIVE: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/CONCLUSIONS: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/METHODS:Level II.
PMID: 33580346
ISSN: 1433-7347
CID: 5183172

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

Blum, Christopher L; Lepkowsky, Eric; Hussein, Adil; Wakelin, Edgar A; Plaskos, Christopher; Koenig, Jan A
INTRODUCTION/BACKGROUND: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/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/CONCLUSIONS: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.
PMID: 34283279
ISSN: 1434-3916
CID: 5063012

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

Keggi, John M; Wakelin, Edgar A; Koenig, Jan A; Lawrence, Jeffrey M; Randall, Amber L; Ponder, Corey E; DeClaire, Jeffrey H; Shalhoub, Sami; Lyman, Stephen; Plaskos, Christopher
INTRODUCTION/BACKGROUND: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/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.
PMID: 34255172
ISSN: 1434-3916
CID: 5063002

The Prevalence of Diabetes Mellitus and Routine Hemoglobin A1c Screening in Elective Total Joint Arthroplasty Patients

Capozzi, James D; Lepkowsky, Eric R; Callari, Marie M; Jordan, Ellen T; Koenig, Jan A; Sirounian, Gregory H
BACKGROUND:Diabetes mellitus has been associated with significant perioperative complications in joint arthroplasty. In addition, many patients are unaware of their dysglycemic status, and the prevalence of undiagnosed dysglycemia in joint arthroplasty patients is unknown. METHODS:Several years ago, we began routine hemoglobin A1c (HbA1c) level screening in all our patients planning to undergo elective total hip and total knee arthroplasties. We retrospectively reviewed the HbA1c levels in our initial 663 patients. RESULTS:Forty-eight percent of these patients were found to be nondiabetic; 19% percent had a previous history of some level of dysglycemia. Most significantly, over one third, 33.6% of these patients were previously undiagnosed dysglycemic patients; 31% were diagnosed as prediabetic and 2.6% as diabetic. CONCLUSION:Owing to the high prevalence of prediabetic patients who go on to develop diabetes and to the high correlation of poor glucose control with perioperative complications, we feel that it is imperative to identify this large number of previously undiagnosed dysglycemic patients. We recommend the routine screening of all patients planning to undergo major orthopedic procedures. Likewise, we recommend that identified patients be referred for diabetic counseling. We also recommend that patients with markedly elevated HbA1c levels have their elective surgery postponed until better glycemic control can be achieved.
PMID: 27452137
ISSN: 1532-8406
CID: 3459512