Risk of tibial baseplate loosening is low in patients following unrestricted kinematic alignment total knee arthroplasty using a cruciate-retaining medial conforming insert: A study using radiostereometric analysis at 2 years.

PURPOSE: Assessing the risk of tibial baseplate loosening in patients after unrestricted kinematically aligned (unKA) total knee arthroplasty (TKA) using a medially conforming insert is important because baseplates generally are aligned in varus which has been linked to an increased incidence of aseptic loosening following mechanically aligned TKA. Two limits that indicate long-term stability in patients are a change in maximum total point motion between 1 and 2 years (ΔMTPM) < 0.2 mm and anterior tilt at 2 years < 0.8°. The purposes were to determine: (1) the number of patients with ΔMTPM > 0.2 mm, (2) the number of patients with anterior tilt > 0.8° and (3) whether increased varus baseplate and limb alignment were associated with increased migration. METHODS: Thirty-five patients underwent cemented, caliper-verified, unKA TKA using a medially conforming tibial insert with posterior cruciate ligament (PCL) retention. Biplanar radiographs acquired on the day of surgery and at 1.5, 3, 6, 12 and 24 months were processed with model-based radiostereometric analysis (RSA) software to determine migration and the number of patients with migration above the two stability limits. Medial proximal tibial angle (MPTA), hip-knee-ankle angle (HKAA) and posterior slope angle (PSA) were analyzed for an association with migration in six degrees of freedom and in MTPM. RESULTS: Thirty-two of 35 patients were available for analysis at 2 years. One patient exhibited ΔMTPM > 0.2 mm. The same patient exhibited anterior tilt > 0.8°. Varus rotation (p = 0.048, r ≤ 0.34) and medial translation (p = 0.0273, r ≤ 0.29) increased with increased varus baseplate alignment. CONCLUSION: The results indicate low risk of long-term baseplate loosening in patients. Although varus rotation and medial translation increased with increased varus baseplate alignment, the magnitudes of the migrations were minimal and did not increase ΔMTPM and anterior tilt. LEVEL OF EVIDENCE: Level II, therapeutic prospective cohort study.

Better forgotten joint scores when the angle of the prosthetic trochlea is lateral to the quadriceps vector in kinematically aligned total knee arthroplasty.

PURPOSE: The primary aim was to analyze unrestricted kinematic alignment (unKA) total knee arthroplasty (TKA) and determine the frequency of medial deviation of the prosthetic trochlear angle (PTA) of the femoral component relative to the quadriceps vector (QV) that terminates at the anterior inferior iliac spine (AIIS), and whether patients with medial deviation had a worse Forgotten Joint Score (FJS) and Oxford Knee Score (OKS) relative to those with lateral deviation. The secondary aim was to determine the frequency of medial deviation for mechanical alignment (MA) TKA simulations. METHODS: From a database of a single surgeon, the study extracted de-identified data on 147 patients with a CT scanogram showing the pelvis and AIIS, a limb with an unKA TKA, and a native (i.e., healthy) opposite limb. On the scanogram, an examiner, blinded to the PROMs, measured the PTA-QV angle on the unKA TKA and on the opposite limb simulated MA TKA by drawing the PTA at 6° valgus relative to the femoral mechanical axis and measuring the PTA-QV angle. RESULTS: Medial deviation of the PTA occurred in 86% of patients with unKA TKA, and the 126 with medial deviation had a 17/1 point worse median FJS/OKS than the 21 with lateral deviation at a mean follow-up of 47 ± 8 months, respectively (p < 0.0001, p = 0.0053). In addition, 21%, 17%, and 8% of MA TKA had medial deviation after radiographic simulation using reported surgical errors for manual, patient-specific, and robotic instrumentation, respectively. CONCLUSION: In most patients with unKA TKA and a smaller proportion with MA TKA, a PTA of 6° valgus was medial to the QV, which, by excluding the patient's Q-angle, might alter patellofemoral kinematics like an incorrectly oriented trochleoplasty. The 17-point worse FJS in the patients with an unKA TKA and medial deviation of the PTA suggests the surgical target should be to orient the PTA lateral to the QV. LEVEL OF EVIDENCE: IV.

State of the Art in Radiostereometric Analysis for Tibial Baseplate Migration and Future Research Directions.

Radiostereometric analysis (RSA) measures movement (migration) of a baseplate relative to the underlying tibia after total knee arthroplasty (TKA) and has been used extensively to evaluate safety of new implant designs and/or surgical techniques regarding baseplate loosening. Because RSA is a complex methodology which involves various choices that researchers make, including whether to use marker-based or model-based methods, which migration metric to report, how to relate short-term migrations to long-term risk, and how these choices impact error, the objectives of this review were to: (1) lay out a comprehensive structure illustrating the multiple components/considerations for RSA and their interrelations, (2) review components of the structure using the latest RSA literature, and (3) use the preceding review as a context for identifying future areas of study. The components to be reviewed were structured using the following topics: type of RSA, migration metrics, sources of error, studies/reports of error, stability limits, and studies of error in stability limits. Based on the current RSA literature and knowledge gaps which exist, the following future research directions were identified: (1) revising the ISO standard to require reporting of clinical measurement error (bias) and recommending use of a local baseplate coordinate system, (2) identifying the migration metric and associated threshold most predictive of baseplate loosening for individual patients, (3) creating a method for data sharing to improve individual patient diagnostics, and (4) determining an appropriate stability limit for model-based RSA for group stability and individual patient diagnostics.

Conditions for Use and Implementation of Globally-Aligned Versus Local Baseplate Coordinate Systems When Computing Migration Using Radiostereometric Analysis.

Radiostereometric analysis can be used for computing movement of a tibial baseplate relative to the tibia (termed migration) to determine stability of fixation. Quantifying migration in six degrees of freedom requires establishing a coordinate system in which to express the movement. Establishing consistent migration directions among patients and baseplate designs remains challenging. Deviations in imaging alignment (tibia/baseplate alignment during image acquisition) and surgical alignment (baseplate alignment on tibia) will affect computed migrations when using the conventional globally-aligned baseplate coordinate system (BCS) (defined by calibration box). Computing migration using a local BCS (defined by baseplate) may be preferrable. This paper (1) summarizes the migration equations when using a globally-aligned versus local BCS, (2) proposes a method for defining a local BCS, and (3) demonstrates differences in the two BCSs for an example patient whose baseplate has rotational deviations due to imaging or surgical alignments. Differences in migration for the two BCSs ranged from about ±0.5 mm in translations and -0.4 deg to 0.7 deg in rotations. Differences were largest for deviations in internal-external rotation and smallest for deviations in varus-valgus rotation. An example demonstrated that the globally-aligned BCS resulted in migration being quantified as subsidence instead of liftoff, thereby changing fundamental interpretations. Because migrations computed using a local BCS are independent of imaging and surgical alignments and instead characterize migration using baseplate features, a local BCS enhances consistency in migration directions among patients and baseplate designs relative to the interface in which fixation may be compromised.

Low tibial baseplate migration 1 year after unrestricted kinematically aligned total knee arthroplasty using a medial conforming implant design.

PURPOSE: Varus alignment of the tibial baseplate and limb > 3° might adversely affect baseplate fixation after total knee arthroplasty (TKA), especially for unrestricted kinematically aligned (KA) TKA which aligns a majority of baseplates in varus. The purposes of this study were to determine whether baseplate migration at 1 year (1) was significantly less than a stability limit of 0.5 mm, (2) increased over time, and (3) was related to varus alignment of the baseplate and limb after unrestricted KA TKA. METHODS: Thirty-five patients underwent unrestricted KA TKA using a fixed-bearing, cemented, medial conforming tibial insert with posterior cruciate ligament retention. Using model-based radiostereometric analysis, maximum total point motion (MTPM) (i.e., largest displacement on the baseplate) was computed at 6 weeks, 3 months, 6 months, and 1 year postoperatively relative to the day of surgery. Baseplate and limb alignment were measured postoperatively on long-leg CT scanograms. RESULTS: At 1 year, mean MTPM of 0.35 mm was significantly less than the 0.5 mm stability limit (p = 0.0002). Mean MTPM did not increase from 6 weeks to 1 year (p = 0.3047). Notably, 89% (31/35) of tibial baseplates and 46% (16/35) of limbs were > 3° varus. Baseplate and limb alignment had no relationship to MTPM at 1 year (|r|≤ 0.173, p ≥ 0.3276). CONCLUSION: Low and non-progressive tibial baseplate migration 1 year after unrestricted KA TKA with a medial conforming design should allay any concern that unrestricted KA TKA increases risk of baseplate loosening due to varus alignment of the baseplate and limb. LEVEL OF EVIDENCE: Level II, therapeutic prospective cohort study.

Error in maximum total point motion of a tibial baseplate is lower with a reverse-engineered model versus a CAD model using model-based radiostereometric analysis.

Because model-based radiostereometric analysis (MBRSA) identifies tibial baseplate designs which increase risk of baseplate loosening, and because registration errors for computer-aided design (CAD) models are large relative to a 6-month stability limit, 3D models more representative of the geometry of implanted baseplates are needed to minimize error. This study tested whether (1) each of three reverse-engineered (RE) models of the same nominal size reduced registration error relative to the equivalent size CAD model, and (2) RE models of multiple sizes reduced registration error relative to CAD models of corresponding sizes. Registration error, quantified as mean artifactual maximum total point motion (aMTPM), was computed between double biplanar radiographs (i.e., two pairs of independent biplanar radiographs from the same day) for thirty-five patients. Double biplanar radiographs were analyzed four times for the most common baseplate size (i.e., size 5) using three RE models and the corresponding CAD model (1st hypothesis) and twice for all patients using one RE model and the equivalent size CAD model (2nd hypothesis). For all three size 5 RE models, mean aMTPM was less than that of the CAD model, though only one RE model reached statistical significance. For multiple size models, mean aMTPM was reduced by 24% when using RE models instead of CAD models, which could mean the difference between categorizing a baseplate as at-risk versus not at-risk relative to a 6-month stability limit. Since error reduction is related to geometry of specific baseplate designs, other baseplate designs should be evaluated using methods presented herein.

Measurement Error Versus Repeated Measurements: A Guide Describing Two Methods for Computing Bias and Precision of Migration Measurements From Double Examinations Using Radiostereometric Analysis.

Radiostereometric analysis is a method to measure implant migration where an ISO standard recommends double examinations (i.e., acquisition of two independent sets of biplanar images on the same day) to compute bias (i.e., mean) and precision (i.e., standard deviation) of differences in repeated migration measurements (termed repeated measurement statistics). However, repeated measurement statistics do not provide information regarding trueness of the measurements. Double examinations also can be used to compute measurement error statistics (i.e., mean and standard deviation of migration measurements relative to trueness). Our objectives were to derive measurement error and repeated measurement population parameters in six degrees of freedom (6DOF) and in maximum total point motion (MTPM), demonstrate quantitative differences by computing measurement error and repeated measurement statistics from a clinical study for an example implant, and demonstrate the importance of determining mean measurement error in MTPM. Three key findings were: (1) in 6DOF, measurement error and repeated measurement statistics were nearly identical; (2) for MTPM, measurement error and repeated measurement statistics had different means of 0.21 mm and 0.00 mm, respectively, but similar standard deviations; and (3) mean measurement error in MTPM is important for drawing conclusions about early implant stability. Because measurement error statistics are the same as repeated measurement statistics in 6DOF but provide additional information in the form of mean measurement error in MTPM, researchers should report measurement error instead of repeated measurement statistics. Furthermore, the ISO standard should be revised to include measurement error statistics.

Previously Unrecognized Source of Error in the Change in Maximum Total Point Motion to Determine Continuous Migration of Unstable Tibial Baseplates.

In radiostereometric analysis (RSA), continuous migration denoted as ΔMTPM is the difference between maximum total point motion (MTPM) at 2 years relative to time zero and MTPM at 1 year relative to time zero. Continuous migration has been used to diagnose tibial baseplates as stable versus unstable when compared to a specified stability limit (i.e., value of ΔMTPM). If the same point experiences MTPM at 2 years and at 1 year (usually the case for marker-based RSA), then an implicit assumption is that the migration path between 2 years and 1 year is the same as the path between 1 year and time zero. This article uses vector analysis to demonstrate a source of error in ΔMTPM not previously recognized and estimates the magnitude of error based on the interplay of independent variables which affect the error. The two independent variables which affect the error are the angle between the two migration vectors (i.e., MTPM between time zero and 2 years and MTPM between time zero and 1 year) and the difference in magnitude of the two vectors. The relative error increased in an absolute sense as the angle between the vectors increased and decreased for larger differences in the magnitudes of the two vectors. For magnitude ratios ranging from 1.25 to 2, relative errors ranged from -21% to -3% at 10 deg and from -78% to -42% at 60 deg, respectively. Knowledge of these errors highlights a limitation in the use of ΔMTPM not previously recognized.

Propagation of registration error into maximum total point motion to analyze tibial baseplate stability at six months using marker-based and model-based RSA.

Maximum total point motion (MTPM) of a tibial baseplate at 6 months is used to predict long-term aseptic loosening after total knee arthroplasty. However, the propagation of registration error into MTPM for stable baseplates (i.e. baseplates with MTPM < 0.5 mm) manifested as bias (i.e. systematic error) and precision (i.e. random error) has not been quantified and compared to the 6-month stability limit for marker-based and model-based RSA, which have different magnitudes of registration error. To determine the bias and precision in MTPM for stable baseplates, registration errors in six degrees of freedom reported in the literature for marker-based and model-based RSA were applied to an example baseplate using computer simulations. Results revealed that the bias in MTPM for stable baseplates with model-based RSA is three to four times that of marker-based RSA, and that the precision in MTPM for stable baseplates with model-based RSA is double that of marker-based RSA. This assessment of bias and precision in MTPM for stable baseplates led to a method for adjusting the 6-month stability limit for model-based RSA where half the width of the 95% confidence interval on the mean MTPM and the bias in MTPM for marker-based RSA were subtracted from 0.5 mm to compute true MTPM. The bias in MTPM and half the width of the 95% confidence interval on the mean MTPM for model-based RSA were then added to the true MTPM to obtain the adjusted stability limit for model-based RSA which ranged from 0.57 mm to 0.64 mm.

Maximum Total Point Motion of Five Points Versus All Points in Assessing Tibial Baseplate Stability.

Maximum total point motion (MTPM), the point on a baseplate that migrates the most, has been used to assess the risk of tibial baseplate loosening using radiostereometric analysis (RSA). Two methods for determining MTPM for model-based RSA are to use either five points distributed around the perimeter of the baseplate or to use all points on the three-dimensional model. The objectives were to quantify the mean difference in MTPM using five points versus all points, compute the percent error relative to the 6-month stability limit for groups of patients, and determine the dependency of differences in MTPM on baseplate size and shape. A dataset of 10,000 migration values was generated using the mean and standard deviation of migration in six-degrees-of-freedom at 6 months from an RSA study. The dataset was used to simulate the migration of three-dimensional models (two baseplate shapes and two baseplate sizes) and calculate the difference in MTPM using five virtual points versus all points and the percent error (i.e., the difference in MTPM/stability limit) relative to the 6-month stability limit. The difference in the MTPM was about 0.02 mm, or 4% relative to the 6-month stability limit, which is not clinically important. Furthermore, results were not affected by baseplate shape or size. Researchers can decide whether to use five points or all points when computing MTPM for model-based RSA. The authors recommend using five points to maintain consistency with marker-based RSA.

Propagation of registration errors into the change in maximum total point motion for determining stability of tibial baseplates.

The change in maximum total point motion (ΔMTPM) is used to predict long-term risk of tibial baseplate loosening, however, effects of registration error on ΔMTPM have not been quantified for marker-based and model-based radiostereometric analysis (RSA). Registration errors for marker-based and model-based RSA were applied to a stable tibial baseplate in MATLAB simulations to determine the bias and precision in ΔMTPM and the proportions of baseplates which fell above the continuous migration stability limit. No bias error occurred, however, the precision of ΔMTPM was twice as large for model-based RSA than marker-based RSA, resulting in about 25% of stable baseplates falling above the continuous migration stability limit for model-based RSA. Reseachers should be aware of these limitations when applying this stability limit to assess tibial baseplate stability using model-based RSA.

Reorienting the tibial baseplate improves the registration accuracy of model-based radiostereometric analysis.

Accuracy of model-based radiostereometric analysis (MBRSA) in calculating tibial baseplate migration depends on baseplate shape and orientation relative to the imaging planes. The primary objectives were to introduce a new method for determining the optimal baseplate orientation to minimize bias error during MBRSA and to demonstrate the clinical usefulness of the method using a knee positioning guide to repeatably orient the baseplate. A tibia phantom was rotated to achieve 24 different orientations with three pairs of radiographs acquired at each orientation. Radiographs were processed in MBRSA software and the mean maximum total point motion (MTPM), an indicator of bias error during model registration, was plotted as a function of the rotation angles to determine the optimal orientation and a range of acceptable orientations. The bias error decreased 85% between the reference orientation and the optimal orientation. An acceptable range of orientations was defined by a decrease in bias error more than 50%. Future researchers can use this method to determine the optimal orientation and a range of acceptable orientations for their specific baseplate to minimize bias error. Clinical usefulness was demonstrated by repeatedly imaging a knee model placed in a knee positioning guide (simulated clinical positioning) and demonstrating that the mean orientation ± one standard deviation fell within the acceptable range of orientations. Thus, use of a knee positioning guide was an effective tool for repeatable patient positioning and should be considered for future RSA studies to maintain consistent positioning during a longitudinal study.