Total knee arthroplasty (TKA) is highly successful due to pain reduction, patient satisfaction, and increased range of motion (ROM) during activities of daily living (ADL). ROM recovery is critical for successful outcomes, however ROM values are typically captured during routine physical therapy (PT) appointments via simplified measures (e.g. goniometric maximum passive ROM). These measures are imprecise, potentially neglecting patients’ home experiences. Accordingly, improved measurement methods are necessary to realistically represent ROM recovery. A validated inertial measurement unit (IMU) method continuously capturing knee ROM was deployed assessing knee ROM recovery during PT appointments and during patients’ routine daily experiences. Our objectives were to 1) continuously capture knee ROM pre-/post-TKA via IMUs and 2) divide each day's data to PT/non-PT segments comparing ‘gold standard’ ROM measurements (PT periods) with non-invasive home measurements (non-PT periods). Given patients are verbally/physically encouraged during PT, we hypothesized PT and non-PT metrics would be significantly different including 1) greater kinematics, 2) shorter times, and 3) greater activity level during PT compared to non-PT. Following IRB approval, IMUs captured long duration, continuous (8–12 hours/day, ∼50 days) knee ROM pre-/post-TKA. Post-TKA metrics were subdivided to PT/non-PT time periods including maximum ROM, gait phase ROMs (stance/swing), gait times (stride/stance/swing), and activity level. Clinical ROM and patient reported outcome measures (PROMs) were also captured before/after TKA. Statistical comparisons were completed between pre-TKA, post-TKA PT, and post-TKA non-PT metrics. Correlation analyses were completed between IMU, clinical ROM, and PROMs.Introduction
Methods
With many stakeholders, healthcare decisions are complex. However, patient interests should be prioritized. This maximizes healthcare value (quality divided by cost), simultaneously minimizing costs (objective) and maximizing quality (subjective). Unfortunately, even ‘high value’ procedures like total knee arthroplasty (TKA) suffer from recovery assessment subjectivity (i.e. high assessment variability) and increasing costs. High TKA costs and utilization yield high annual expenditures (∼$22B), including postoperative physical therapy (PT) accounting for ∼10% of total costs (∼$2.3B annually). Post-TKA PT is typically homogenous across subjects ensuring most recover, however recent work shows outcomes unimpacted by PT. Accordingly, opportunities exist improving healthcare value by simultaneously reducing unnecessary PT expenditures and improving outcomes. However, discerning recovery completion relies on discrete ROM measures captured clinically and subjective clinician experience (i.e. intuition about recovery). Accordingly, our goal was developing objective post-TKA performance assessment methods utilizing gait knee ROM and statistical analyses to categorize patient recovery (‘accelerated,’ ‘delayed,’ or ‘normal’). We first established statistical reasons for current post-TKA rehabilitation including risk-reward tradeoffs between incorrectly ascribing ‘poor recovery’ to well-recovering patients (T1 error) or ‘good recovery’ to poorly-recovering patients (T2 error) using methods described by Mudge et al. and known TKA volumes/rehabilitation costs. Next, previously captured gait ROM data from well-healed patients was utilized establishing standard recovery curves. These were then utilized to assess newly captured patient recovery. Following IRB approval, we prospectively captured gait ROM from 10 TKA patients (3M, 69±13 years) 1-week pre-TKA and 6-weeks immediately post-TKA. Performance was compared to recovery curves via control charts/Shewhart rules (daily performance) as well as standard deviation thresholds (weekly performance) establishing recovery as ‘accelerated,’ ‘delayed,’ or ‘normal.’ The categorization was extrapolated to US TKA population and savings/expenses quantified. Statistical analyses were performed in Minitab with statistical significance set to α<0.05.Introduction
Methods
We introduce a novel active tensioning system that can be used for dynamic gap-based implant planning as well as for assessment of final soft tissue balance during implant trialing. We report on the concept development and preliminary findings observed during early feasibility testing in cadavers with two prototype systems. The active spacer (fig 1) consists of a motorized actuator unit with integrated force sensors, independently actuated medial and lateral upper arms, and a set of modular attachments for replicating the range of tibial baseplate and insert trial sizes. The spacer can be controlled in either force or position (gap) control and is integrated into the OMNIBoticsTM Robotic-assisted TKA platform (OMNI, MA, USA). Two design iterations were evaluated on eleven cadaver specimens by seven orthopaedic surgeons in three separate cadaver labs. The active spacer was used in a tibial-first technique to apply loads and measure gaps prior to and after femoral resections. To determine the range of forces applied on the spacer during a varus/valgus assessment procedure, each surgeon performed a varus/valgus stress test and peak medial and lateral forces were measured. Surgeons also rated the feel of the stability of the knee at 50N and 80N of preload using the following scale: 1 – too loose; 2 – slightly loose; 3 – ideal; 4 slightly tight; 5 – too tight. Final balanced was assessed with the spacer and with manual trial components.System description
Cadaver Study
Knee instability, stiffness, and soft-tissue imbalance are causes of aseptic revision and patient dissatisfaction following total knee arthroplasty (TKA). Surgical techniques that ensure optimal ligament balance throughout the range of motion may help reduce TKA revision for instability and improve outcomes. We evaluated a novel tibial-cut first gap balancing technique where a computer-controlled tensioner is used to dynamically apply a varying degree of distraction force in real-time as the knee is taken through a range of motion. Femoral bone cuts can then be planned while visualizing the predicted knee implant laxity throughout the arc of flexion. After registering the mechanical axes and morphology of the tibia and femur using computer navigation, the tibial resection was performed and a robotic tensioning tool was inserted into the knee prior to cutting the femur. The tool was programmed to apply equal loads in the medial and lateral compartments of the knee, but to dynamically vary the distraction force in each compartment as the knee is flexed with a higher force being applied in extension and a progressively lower force applied though mid-flexion up to 90° of flexion. The tension and predictive femoral gaps between the tibial cut and the femoral component in real-time was determined based on the planned 3D position and size of the femoral implant and the acquired pre-resection gaps (figure 1). Femoral resections were then performed using a robotic cutting guide and the trial components were inserted.Introduction
Surgical Technique Description
Proponents of quadriceps-sparing (QS) subvastus approach for total knee arthroplasty (TKA) suggest short-term advantages including better early functional results, less pain and shorter hospital stay. However, because of potentially reduced visibility and exposure, the QS approach may compromise component alignment – an important surgeon-controlled outcome affecting implant longevity. The purpose of this study was to determine if a QS approach resulted in compromised component alignment compared to a medial parapatellar arthrotomy (MPPA), when both were performed with contemporary minimally invasive surgery (MIS) principles including small incision (≤ 15 cm), MIS instrumentation, patellar subluxation without eversion, and in situ bone cuts. This prospective, randomized, double-blinded study enrolled 128 patients with knee osteoarthritis undergoing primary TKA using the same cemented, posterior-stabilized prosthesis. After skin incision, patients were randomized to MPPA (n = 66) or QS technique (n = 62), with all surgeries performed by two fellowship-trained arthroplasty surgeons. Using the Knee Society roentgenographic evaluation system, two reviewers blinded to the surgical approach evaluated post-operative radiographs to measure coronal and sagittal plane alignment using the standing femoral and tibial angles as well as the lateral femoral flexion and tibial angles. Inter-observer agreement was ensured by a secondary review of all x-rays where the two observers differed by more than 1 degree in their measurements of a specific radiograph. Differences in mean angles were evaluated using the general linear model and differences in proportions were evaluated using binary regression. All analyses were conducted with SAS 9.3 on the Windows Ultimate 64-bit operating system.Introduction:
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