Recent advances in 3D printing enable the use of custom patient-specific instruments to place drill guides and cutting slots for knee replacement surgery. However, such techniques limit the ability to intra-operatively adjust an implant plan based on soft-tissue tension and/or joint pathology observed in the operating room, e.g. cruciate ligament integrity. It is hypothesized that given the opportunity, a skilled surgeon will make intra-operative adjustments based on intra-operative information not captured by the hard tissue anatomy reconstructed from a pre-operative CT scan or standing x-ray. For example, tibiofemoral implant gaps measured intra-operatively are an indication of soft-tissue tension in the patient's knee, and may influence a surgeon to adjust implant position, orientation or size. This study investigates the frequency and magnitude of intra-operative adjustments from a single orthopedic surgeon during 38 unicondylar knee arthroplasty (UKA) cases. For each patient, a pre-operative plan was created based on the bony anatomy reconstructed from the pre-operative CT. This plan is analogous to a plan created with patient-specific cutting blocks or customized implants. With robotic technology that utilizes pre-operative imaging, intra-operative navigation and robotic execution, this “anatomic” plan can be fine-tuned and adjusted based on the soft tissue envelop measured intra-operatively. The relative positions of the femur and the tibia are measured intra-operatively under a valgus load (for medial UKA, varus load for lateral UKA) for each patient from extension to deep knee flexion and used to compute the predicted space between the implants (gaps) throughout flexion. The planned position, orientation and size of the components can then be adjusted to achieve an optimal dynamic ligament balance prior to any bony cuts. This is the plan that is then executed under robotic guidance. Intra-operative adjustments are defined as any size, position or orientation changes occurring intra-operatively to the pre-operative anatomic plan.Introduction
Methods
Bicompartmental knee arthroplasty (BKA) is an alternative to total knee arthroplasty (TKA) for degenerative joint disease when present in only two compartments. BKA spares the cruciate ligaments and preserves bone in the healthy compartment, possibly leading to better knee kinematics and clinical outcomes when compared to TKA. While BKA is a technically demanding procedure when performed with manual instrumentation, robotic assistance allows for accurate implant placement and soft tissue balancing of the joint. Robotic unicompartmental knee arthroplasty (UKA) has shown favorable clinical outcomes and survivorship at short term (2 year) follow up compared to manual UKA. The purpose of this study is to evaluate the short term functional outcomes and survivorship of patients undergoing robotically assisted BKA. 45 patients (48 knees) were identified in an initial and consecutive single surgeon series receiving robotically assisted BKA to correct disease in the medial and patellofemoral compartments. As part of an IRB approved study, every patient in the series was contacted at a minimum two year (±2 months) follow up and asked a series of questions to determine implant survivorship and functional outcomes (using the patient portion of the Knee Society Score). 9 patients were lost to follow up and 1 patient was deceased. 35 patients (38 knees) at a minimum two year follow up enrolled in the study for an enrollment rate of 79%. There are 22 male patients and 13 female patients; the average age at time of surgery is 67.0 ± 6.8 and the average BMI is 29.5 ± 4.6. Five patients in this series also qualified for a 5 year follow up assessment.INTRODUCTION
METHODS
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
Bicompartmental knee arthroplasty (BKA) is an alternative to total knee arthroplasty (TKA) for degenerative joint disease when present in only two compartments. BKA spares the cruciate ligaments and preserves bone in the healthy compartment, possibly leading to better knee kinematics and clinical outcomes when compared to TKA. While BKA is a technically demanding procedure when performed with manual instrumentation, robotic assistance allows for accurate implant placement and soft tissue balancing of the joint. Robotic unicompartmental knee arthroplasty (UKA) has shown favorable clinical outcomes and survivorship at short term (2 year) follow up compared to manual UKA. The purpose of this study is to evaluate the short term functional outcomes and survivorship of patients undergoing robotically assisted BKA. 45 patients (48 knees) were identified in an initial and consecutive single surgeon series receiving robotically assisted BKA to correct disease in the medial and patellofemoral compartments. As part of an IRB approved study, every patient in the series was contacted at a minimum two year (±2 months) follow up and asked a series of questions to determine implant survivorship and functional outcomes (using the patient portion of the Knee Society Score). 9 patients were lost to follow up and 1 patient was deceased. 35 patients (38 knees) at a minimum two year follow up enrolled in the study for an enrollment rate of 79%. There are 22 male patients and 13 female patients; the average age at time of surgery is 67.0 ± 6.8 and the average BMI is 29.5 ± 4.6. Five patients in this series also qualified for a 5 year follow up assessment.INTRODUCTION
METHODS
Unicompartmental Knee Arthroplasty (UKA) has been offered as a tissue sparing alternative to total knee arthroplasty (TKA) for treatment of early to mid-stage osteoarthritis (OA). While the spared tissue and retention of cruciate ligaments may result in faster recovery, smaller incision, less bone resection, decreased pain and blood loss and more normal kinematics and function, UKA has shown unpredictable results in practice, which may be due to variations in surgical techniques1. Recently a robotic-assisted technique has been introduced as a means to provide more consistent and reproducible surgical results. In this study, the early return to function was measured to determine proposed benefits between UKA and TKA. Patients requiring either UKA or TKA were prospectively enrolled in this IRB approved study. Each patient received pre-operative education regarding their expected physical therapy (PT) regimen, which was uniform for all patients. PT was determined to be concluded when each patient reached an achievable functional endpoint with each of the following 5 criteria: range of motion from 5 to 115 degrees, recovery of flexion and extension strength to 4/5 of pre-operative strength, gait with minimal limp and without an assistive device for 250 feet and ability to ascend and descend a flight of stairs with step over gait and good control. The number of PT visits to reach each functional goal was recorded.Introduction
Methods
Unicompartmental knee arthroplasty (UKA) can achieve excellent clinical and functional results for patients suffering from single compartment osteoarthritis. However, UKA is considered to be more technically challenging to perform, and malalignment of the implant components has been shown to significantly contribute to UKA failures. The purpose of this investigation was to determine the clinically realized accuracy of UKA component placement using surgical navigation and dynamically referenced tactile-robotics. Pre-op CT, post-op CT, and surgical plan were available for 22 knees out of the first 45 procedures performed using a new tactile-guided robotic system. 3D component placement accuracy was assessed by comparing the pre-operative plan with the post-operative implant placement (desired versus actual). Bone and implant models were obtained from postoperative CT scans taken immediately following the surgery. A 3D to 3D iterative closest point registration procedure was performed and the measured implant position was directly compared to the preoperative plan. Errors were assessed as single axis root-mean-square (RMS) entities.INTRODUCTION
METHODS
