Valgus deformity in an end stage osteoarthritic knee can be difficult to correct with no clear consensus on case management. Dependent on if the joint can be reduced and the degree of medial laxity or distension, a surgeon must use their discretion on the correct method for adequate lateral releases. Robotic assisted (RA) technology has been shown to have three dimensional (3D) cut accuracy which could assist with addressing these complex cases. The purpose of this work was to determine the number of soft tissue releases and component orientation of valgus cases performed with RA total knee arthroplasty (TKA). This study was a retrospective chart review of 72 RATKA cases with valgus deformity pre-operatively performed by a single surgeon from July 2016 to December 2017. Initial and final 3D component alignment, knee balancing gaps, component size, and full or partial releases were collected intraoperatively. Post-operatively, radiographs, adverse events, WOMAC total and KOOS Jr scores were collected at 6 months, 1 year and 2 year post-operatively.Introduction
Methods
Studies have shown that dissatisfaction following TKA may stem from poor component placement and iatrogenic factors related to variability in surgical execution. A CT-based robotic assisted system (RA) allows surgeons to dynamically balance the joint prior to bone resection. This study aimed to determine if this system could improve TKA planning, reduce soft tissue releases, minimize bone resection, and accurately predict component size in varus knee. Four hundred and seventy four cases with varus deformity undergoing primary RATKA were enrolled in this prospective, single center and surgeon study. Patient demographics and intraoperative surgical details were collected. Initial and final 3-dimensional alignment, component position, bone resection depths, use of soft tissue releases, knee balancing gaps, and component size were collected intraoperatively. WOMAC and KOOS Jr. scores were collected 6 months, and 1 year postoperatively. Descriptive statistics were applied to determine the changes in these parameters between initial and final values.Introduction
Method
Component position and overall limb alignment following Total Knee Arthroplasty (TKA) have been shown to influence device survivorship and clinical outcomes. However current methods for measuring post-operative alignment through 2D radiographs and CTs may be prone to inaccuracies due to variations in patient positioning, and certain anatomical configurations such as rotation and flexion contractures. The purpose of this paper is to develop a new vector based method for overall limb alignment and component position measurements using CT. The technique utilizes a new mathematical model to calculate prosthesis alignment from the coordinates of anatomical landmarks. The hypothesis is that the proposed technique demonstrated good accuracy to surgical plan, as well as low intra and inter-observer variability. This study received institutional review board approval. A total of 30 patients who underwent robotic assisted TKA (RATKA) at four different sites between March 2017 and January 2018 were enrolled in this prospective, multicenter, non-randomized clinical study. CT scans were performed prior to and 4–6 weeks post-operatively. Each subject was positioned headfirst supine with the legs in a neutral position and the knees at full extension. Three separate CT scans were performed at the anatomical location of the hip, knee, and ankle joint. Hip, knee, and ankle images were viewed in 3D software and the following vertices were generated using anatomical landmarks: Hip Center (HC), Medial Epicondyle Sulcus (MES), Lateral Epicondyle (LE), Femur Center (FC), Tibia Center (TC), Medial Malleolus (MM), Lateral Malleolus (LM), Femur Component Superior (FCS), Femur Component Inferior (FCI), Coronal Femoral Lateral (CFL), Coronal Femoral Medial (CFM), Coronal Tibia Lateral (CTL), and Coronal Tibia Medial (CTM). Limb alignment and component positions were calculated from these vertices using a new mathematical model. The measurements were compared to the surgeons’ operative plan and component targeted positions for accuracy analysis. Two analysts performed the same measurements separately for inter-observer variability analysis. One of the two analysts repeated the measurements at least 30 days apart to assess intra-observer variability. Correlation analysis was performed on the intra-observer analysis, while Bland Altman analysis was performed on the inter-observer analysis.Introduction
Methods
Component position and overall limb alignment following total knee arthroplasty (TKA) have been shown to influence prosthetic survivorship and clinical outcomes. Robotic-assisted (RA) total knee arthroplasty has demonstrated improved accuracy to plan in cadaver studies compared to conventionally instrumented (manual) TKA, but less clinical evidence has been reported. The objective of this study was to compare the three-dimensional accuracy to plan of RATKA with manual TKA for overall limb alignment and component position. A non-randomized, prospective multi-center clinical study was conducted to compare RATKA and manual TKA at 4 U.S. centers between July 2016 and August 2018. Computed tomography (CT) scans obtained approximately 6 weeks post-operatively were analyzed using anatomical landmarks. Absolute deviation from surgical plans were defined as the absolute value of the difference between the CT measurements and surgeons’ operative plan for overall limb, femoral and tibial component mechanical varus/valgus alignment, tibial component posterior slope, and femoral component internal/external rotation. We tested the differences of absolute deviation from plan between manual and RATKA groups using stratified Wilcoxon tests, which controlled for study center and accounted for skewed distributions of the absolute values. Alpha was 0.05 two-sided. At the time of this abstract, data collections were completed for two centers (52 manual and 58 RATKA).Introduction
Methods
While total knee arthroplasty has demonstrated clinical success, final bone cut and final component alignment can be critical for achieving a desired overall limb alignment. This cadaver study investigated whether robotic-arm assisted total knee arthroplasty (RATKA) allows for accurate bone cuts and component position to plan compared to manual technique. Six cadaveric specimens (12 knees) were prepared by an experienced user of manual total knee arthroplasty (MTKA), who was inexperienced in RATKA. For each cadaveric pair, a RATKA was prepared on the right leg and a MTKA was prepared on the left leg. Final bone cuts and final component position to plan were measured relative to fiducials, and mean and standard deviations were compared. Measurements of final bone cut error for each cut show that RATKA had greater accuracy and precision to plan for femoral anterior internal/external (0.8±0.5° vs. 2.7±1.9°) and flexion/extension* (0.5±0.4° vs. 4.3±2.3°), anterior chamfer varus/valgus* (0.5±0.1° vs. 4.1±2.2°) and flexion/extension (0.3±0.2° vs. 1.9±1.0°), distal varus/valgus (0.5±0.3° vs. 2.5±1.6°) and flexion/extension (0.8±0.5° vs. 1.1±1.1°), posterior chamfer varus/valgus* (1.3±0.4° vs. 2.8±2.0°) and flexion/extension (0.8±0.5° vs. 1.4±1.6°), posterior internal/external* (1.1±0.6° vs. 2.8±1.6°) and flexion/extension (0.7±0.6° vs. 3.7±4.0°), and tibial varus/valgus* (0.6±0.3° vs. 1.3±0.7°) rotations, compared to MTKA, respectively, (where * indicates a significant difference between the two operative methods based on 2- Variances testing, with α at 0.05). Measurements of final component position error show that RATKA had greater accuracy and precision to plan for femoral varus/valgus* (0.6±0.3° vs. 3.0±1.4°), flexion/extension* (0.6±0.5° vs. 3.0±2.1°), internal/external (0.8±0.5° vs. 2.6±1.6°), and tibial varus/valgus (0.7±0.4° vs. 1.1±0.8°) than the MTKA control, respectively. In general, RATKA demonstrated greater accuracy and precision of bone cuts and component placement to plan, compared to MTKA in this cadaveric study. For further confirmation, RATKA accuracy of component placement should be investigated in a clinical setting.
Total knee arthroplasty (TKA) is a routine, cost-effective treatment for end-stage arthritis. While the evidence for good-to-excellent patient-reported outcomes and objective clinical data is present, approximately 20% of patients continue to be dissatisfied with results of their surgery. Dissatisfaction is strongly correlated with unmet patient expectations, and these patients may experience a higher cost of care due to recurring office and emergency visits. Therefore, this survey asked a large group of United States (U.S) and international surgeons to prioritize areas of opportunity in primary TKA. Specifically, we compared surgeon responses regarding: 1) the top 5 areas needing improvement; which were stratified by: 2) surgeons' years of experience; and 3) surgical case volume. A total of 418 orthopaedic surgeons were surveyed. Two hundred U.S. surgeons and 218 international surgeons participated from 7 different countries including: The United Kingdom (40), France (40), Germany (43), Italy (40), Spain (38), and Australia (17). To participate, surgeons had to be board certified, in practice for 2 years, spend 60% of their time in clinical practice, and perform a minimum of 25 joint arthroplasties per year. Surgeons were asked to choose the top 5 areas of improvement for TKA from a list of 17 attributes including clinical and functional outcomes, procedural workflow and economic variables. Surgeons were able to specify additional options if needed. Results were stratified by annual case volume (25 to 50; 51 to 100; greater than 100 cases) and years of experience (1 to 10; 11 to 20; greater than 20). Single-tail proportion tests were used to compare results between cohorts, where an alpha of 0.05 was set as significant.Background
Methods
Revision for instability has supplanted revision for aseptic loosening and revision for osteolysis since the advent of improved polyethylene inserts with changes in both sterilization techniques and cross-linking. Having the ability to judiciously choose a higher level of constraint may be beneficial in complex primary total knee arthroplasty (TKA) scenarios which can not be balanced through traditional surgical methods. The purpose of this work was to investigate short term outcomes and survivorship in cases where a greater stabilizing insert was used with a posterior stabalizing (PS) femur to address instability in flexion or extension. Two high volume TKA centers retrospectively reviewed cases in which a greater stabilizer insert was used with a primary PS knee system. The studied insert had +/− 2 degrees of varus-valgus coronal restraint as opposed the standard with no coronal constraint. The study inserts had 7 degrees of transverse plane rotational freedom. The inserts were used when extension balance was not achieved despite the usual soft tissue releases and a thicker insert resulted in a flexion contracture statically during the procedure. This situation typically occurred in the following patient groups: valgus knees with medial collateral (MCL) stretching, iatrogenic MCL injury, varus knees with lateral ligament complex stretching, the “double-varus” knee, and patients with a previous high tibial osteotomy. Intra-operatively patients were taken through a range of motion and trial implants were then placed. A cruciate retaining trial insert was then used to assess stability so that a true assessment could be made of ligament balance. Bone cuts were checked before ligament release. The usual releases were then performed to achieve balance including subperiosteal releases medially and laterally and pie-crusting when indicated. Repeat trial reductions were then performed once the final implants were cemented in place again using the cruciate retaining insert. If the soft tissue releases did not achieve balance and a thicker insert resulted in a flexion contracture then the greater stabilizer insert was selected over the PS insert. Knee Society Score and plain radiographs were collected at pre-op, 2 year and 5 year follow-up.Introduction
Methods
The use of cementless TKA's has been gradually increasing over the past several years given the increasing life expectancy of our patient population. Cementless TKA's have not been rapidly adopted due to the challenges and uncertainty of tibial fixation especially in elderly patients. With the advent of new technologies, the results of cementless TKA's with the potential for long term biologic fixation may now be equivalent or better than cemented TKA's. A highly porous tibial baseplate was developed based on proximal tibial anatomy using CT scans using 3D printing technology with focus on length, location and design of press-fit pegs. The purpose of this study was to review the early results with respect to fixation and complications using a new, highly porous cementless tibial baseplate designed for biologic fixation.Introduction
Objectives
Preoperative templating of femoral and tibial components can assist in choosing the appropriate implant size prior to TKA. While weight bearing long limb roentograms have been shown to provide benefit to the surgeon in assessing alignment, disease state, and previous pathology or trauma, their accuracy in size prediction is continually debated due to scaling factors and rotated views. Further, they represent a static time point, accounting for boney anatomy only. A perceived benefit of robotic-assisted surgery is the ability to pre-operatively select component sizes with greater accuracy based on 3D information, however, to allow for flexibility in refining based on additional data only available at the time of surgery. The purpose of this study was to determine the difference of pre-operative plans in size prediction of the tibia, femur, and polyethylene insert. Eighty four cases were enrolled at three centers as part of an Investigational Device Exemption to evaluate a robotic-assisted TKA. All patients had a CT scan as part of a pre-operative planning protocol. Scans were segmented and implant sizes predicted based on the patients boney morphology and an estimated 2mm cartilage presence. Additional information such as actual cartilage presence and soft tissue effects on balance and kinematics were recorded intra-operatively. Utilizing this additional information, surgical plans were fine tuned if necessary to achieve minimal insert thickness and balance. Data from the Preoperative CT plan sizing and final size were compared to determine the percentage of size and within one size accuracy.Introduction
Methods
Total knee arthroplasty (TKA) using conventional instrumentation has been shown to be a safe and effective way of treating end stage osteoarthritis by restoring function and alleviating pain. As robotic technology is developed to assist surgeons with intra-operative decision making such as joint balancing and component positioning, the safety of these advancements must be established. Furthermore, functional recovery and clinical outcomes should achieve comparable results to the gold standard of conventional instrumentation TKA. Eighty-seven subjects (89 knees) underwent robotic arm assisted TKA by one of three investigators as part of an FDA and IRB approved Investigational Device Exemption (IDE). To achieve the primary endpoint of intra-operative patient safety using a robotic arm assisted cutting tool, the investigators completed questionnaires to assess a series of complications related to soft tissue damage associated with conventional TKA. Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee Society Knee Scores (KSS) were collected pre-operatively and at three month follow-up.Introduction
Methods
Total knee arthroplasty (TKA) is a well established treatment option for patients with end stage osteoarthritis. Conventional TKA with manual instruments has been shown to be a cost effective and time efficient surgery. While robotic-assisted operative systems have been shown to have benefits in surgical accuracy, they have also been reported to have longer surgical times. The purpose of this work was to determine surgical time and learning curve for a novel robotic-assisted TKA platform. Eighty-five subjects underwent robotic-assisted TKA by one of three investigators as part of an FDA and IRB approved Investigational Device Exemption (IDE). All patients received a cruciate retaining total knee implant system. Intra-operative safety, Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee Society Scores (KSS) were collected pre-operatively and at three month follow-up. In addition, surgical times were collected as part of a TKA work flow. To identify activities related to surgical steps required for robotic procedures specific time stamps were determined from the system. Capture of the hip center to final bone cut was used to define case time and identify robotic learning curve. Descriptive statistics were used to analyze results.Introduction
Methods
Total knee arthroplasty (TKA) is one of the most common orthopaedic procedures performed, and is projected to exponentially increase over the next 20 years. As primary TKA cases increase, so does the frequency of revisions. The primary goals for all TKA cases include alleviating pain and improving overall knee function. The objective of this study was to evaluate the change in outcomes as measured by the Knee Society Score (KSS) between primary and revision TKA systems. This data was collected as part of three prospective, post-market, multicenter studies comparing preoperative to 6-week data. Patients were stratified into two groups based on type of single radius knee device; Posteriorly Stabilized (PS) group and Total Stabilizer (TS) group. Early clinical outcomes based on the KSS and operative data were used to compare groups.1) INTRODUCTION
2) METHODS
Total knee arthroplasty (TKA) is a common surgery to relieve knee pain and increase range of motion due to osteoarthritis (OA) in older patients. Minimally invasive, computer navigated techniques are gaining popularity for knee replacement surgery. These techniques may have potential to provide better functional outcomes over a shorter period of time. Little data exists comparing the early functional recovery of patients following total knee replacement surgery performed using various common approaches. This study compares the functional gait of patients two months after surgery performed using one of four common approaches to determine if differences exist in the immediate recovery. This knowledge will aid surgeons determine the best approach to use when performing surgery. This study was approved by the appropriate Institutional Review Board. Subjects volunteered to participate in the study and signed informed consent prior to testing. Subjects were excluded if the had significant diseases of the other joints of the lower extremity or a diagnosed disorder with gait disturbance. Patients were randomly assigned to receive unilateral primary TKA using standard parapatellar, mini-parapatellar, mini-midvastus, or mini-subvastus approaches. All patients received the same preoperative, perioperative, and postoperative critical pathways and standard orders. All incisions were five inches and all patients and examiners blinded to type of approach. Surgery was performed by one of two fellowship trained orthopedic surgeons. Patients visited the gait laboratory two months after receiving TKA. Motion data was captured using a ten-camera motion capture system (Motion Analysis Corp., Santa Rosa, CA). Three-dimensional force data was recorded using four floor embedded force platforms (AMTI Inc., Watertown, MA). Patients were asked to walk at a self selected speed along a 6.5 metre walkway. A minimum of five good foot strikes for each limb were recorded. Data were collected using EVaRT 5 software (Motion Analysis Corp., Santa Rosa, CA) and analyzed using OrthoTrak 6.2.8 (Motion Analysis Corp., Santa Rosa, CA) and MatLab software (The Mathworks Inc., Natick, MA). Statistical analysis was performed using SPSS 14.0 software (SPSS Inc., Chicago, Il) (α = 0.05). Fifty-two patients (72 ± 6 years) volunteered to participate in the study. The approaches used were: standard parapatellar – 12; mini-parapatellar – 12; mini-midvastus – 14; mini-subvastus – 14. Statistical analysis found no significant differences in any of the variables measured except minimum knee flexion angle during stance (p=.046). The variables measured included the maximum and minimum injured lower limb joint angles in all planes during both stance and swing phase of gait. Also measured were the maximum joint moments in all planes during stance and hip, knee, and ankle powers. Patients who received TKA using the mini-subvastus approach had greater knee extension through much of the single stance phase of the gait cycle which contributed to a lower (but not significant) peak knee flexion moment. These patients also had the highest ground reaction shear forces with higher ankle power absorption at foot strike and generation at push off. Mini-subvastus patients used a higher cadence to walk with a greater velocity then patients who received surgery using the other approaches. The results of this study show only minor differences in gait between patients who have received surgery using the different approaches. The limited numbers of patients in the study and the large variation in outcomes so soon after surgery mean that in most cases the differences that were measured do not reach significant level. This study shows that the surgical approach used to implant the device has no apparent effect on the ability of the person to ambulate following surgery, however further study with increased numbers of patients and observation over a longer period of time will allow a stronger conclusion. The knowledge gained from this and future studies will enable surgeons to make decisions on type of approach based on factors other than expectations of functional outcome.
Previous studies ( This study was approved by the Sun Health Institutional Review Board. Subjects volunteered to participate in the study and signed informed consent prior to testing. Subjects were excluded if the had significant diseases of the other joints of the lower extremity or a diagnosed disorder with gait disturbance. Motion data was captured using a ten-camera motion capture system (Motion Analysis Corp., Santa Rosa, CA). Three-dimensional force data was recorded using four floor embedded force platforms (AMTI Inc., Watertown, MA). Patients were asked to walk at a self selected speed along a 6.5 meter walkway. A minimum of five good foot strikes for each limb were recorded. Data were collected using EVaRT 5 software (Motion Analysis Corp., Santa Rosa, CA) and analyzed using OrthoTrak 6.2.8 (Motion Analysis Corp., Santa Rosa, CA) and MatLab software (The Mathworks Inc., Natick, MA). Statistical analysis was performed using SPSS 14.0 software (SPSS Inc., Chicago, Il) (α = 0.05). Eighty-six patients (71 ± 7 years) along with sixty-four control subjects (65± 10 years) volunteered to participate in the study. All measured temporal and spatial parameters showed significant differences between the OA patients and the control group. The OA patients were found to walk at a significantly lower velocity (p<
.01) and cadence (p<
.01) using a wider step width (p<
.01) than the control subjects. Patients had their injured knee significantly more flexed at foot strike (p<
.01) but flexed the knee significantly less during swing (p<
.01) when compared to the control group. Patients had significantly higher knee flexion angles as well as hip flexion and abduction angles during stance. Knee varus angles were significantly higher for the OA patients during stance (p<
.01) but not during swing when compared to the control group. Significant increases in pelvic tilt and pelvic obliquity were measured during the stance phase. Hip abduction angles during stance were significantly lower for the OA group. Patients generated significantly lower vertical ground reaction forces during stance (p<
.01) while sagittal plane kinetic analysis showed significantly lower external knee flexion moments (p<
.01) and knee power generation (p<
.01) during this phase of the gait cycle. Analysis of frontal plane angles showed OA patients had a significantly higher maximum knee varus angle during stance as well as generating a higher external knee varus moment (p=.03) during this phase of the gait cycle. Changes in gait measured in this study support and enhance findings from previous studies. OA patients appeared to walk with a more crouched posture with higher knee and hip flexion angles through mid stance. This along with lower velocity and cadence and a larger step width would indicate a desire for more stability while walking. Patients also flexed their knees more at foot strike in an attempt to absorb the forces generated during weight acceptance. While knee flexion angles measured for the OA group were similar to the control subjects during the initial period of stance, the OA patients did not extend their knees as much during mid stance indicating a desire to reduce the angular rotation of the knee while in single support. Changes measured in frontal plane angles of the hip and pelvis may be an attempt to compensate for the different angles generated by the knee during stance. The differences in hip and knee angles measured during stance for patients and controls allowed patients to have reduced peak external knee flexion moments during initial stance but a higher knee flexion moment at mid stance. The reduction in knee angular change during stance and the reduced cadence meant power absorption during early and late stance and generation during mid stance was much lower for the OA patients than the control group. All the changes noted appear to be designed to limit the movement of the knee joint while loaded and reduce the peak loads in an effort to reduce pain at the affected joint while at the same time increase stability during gait. These data show the differences that exist between the gait patterns of patients with advanced osteoarthritis and healthy age-matched persons and highlight the changes that are necessary following knee replacement surgery and rehabilitation to return the gait of these patients to normal.
