Dose reduction does not impact the precision of CT-based RSA in tibial implants: a diagnostic accuracy study on precision in a porcine cadaver.

BACKGROUND AND PURPOSE: Radiostereometric analysis (RSA) is the gold standard for evaluation of migration of implants. CT-RSA has been shown to have precision at the level of RSA in hip, shoulder, and knee joint replacements. We aimed to assess the impact of dose reduction on precision of CT-RSA on tibial implants, comparing it with previously published data on precision of standard dose CT-RSA on tibial implants. MATERIAL AND METHODS: We performed a total knee arthroplasty on a porcine knee cadaver, and subsequent CT-RSA with low effective doses (0.02 mSv). We compared the results with previously published CT-RSA data with standard (0.08 mSv) dose. The primary outcome variable was the difference in precision of the maximum total translation (MTT). Secondary variables included ratios of variances and standard deviations, and precision of peripheral point translations, center-of-mass translations, and rotations. A difference of more than 0.1 mm in precision was defined as clinically relevant. Our hypothesis was that precisions of low and standard CT-RSA doses were equal. RESULTS: Low dose (mean 0.07, 95% confidence interval [CI] 0.06-0.08) and standard dose CT-RSA (0.08, CI 0.07-0.09) achieve similar precision, with difference in precision of MTT of 0.01, CI 0.00-0.02 mm. The F-statistic (0.99, CI 0.63-1.55) and sdtest (1.05, CI 0.43-2.58) also supported this. CONCLUSION: We conclude that the precision of low dose CT-RSA for tibial implants on a porcine cadaver is equal to standard dose CT-RSA. However, these findings should be confirmed in clinical trials.

CT-based migration analysis is more precise than radiostereometric analysis for tibial implants: a phantom study on a porcine cadaver.

BACKGROUND AND PURPOSE: Radiostereometric analysis (RSA) is the gold standard for migration analysis, but computed tomography analysis methods (CTRSA) have shown comparable results in other joints. We attempted to validate precision for CT compared with RSA for a tibial implant. MATERIAL AND METHODS: RSA and CT were performed on a porcine knee with a tibial implant. Marker-based RSA, model-based RSA (MBRSA), and CT scans from 2 different manufacturers were compared. CT analysis was performed by 2 raters for reliability evaluation. RESULTS: 21 double examinations for precision measurements for RSA and CT-based Micromotion Analysis (CTMA) were analysed. Mean (95% confidence interval) precision data for maximum total point motion (MTPM) using marker-based RSA was 0.45 (0.19-0.70) and 0.58 (0.20-0.96) using MBRSA (F-statistic 0.44 [95% CI 0.18-1.1], p = 0.07). Precision data for total translation (TT) for CTMA was 0.08 (0.03-0.12) for the GE scanner and 0.11 (0.04-0.19) for the Siemens scanner (F-statistic 0.37 [0.15-0.91], p = 0.03). When comparing the aforementioned precision for both RSA methods with both CTMA analyses, CTMA was more precise (p < 0.001). The same pattern was seen for other translations and migrations. Mean effective radiation doses were 0.005 mSv (RSA) (0.0048-0.0050) and 0.08 mSv (CT) (0.078-0.080) (p < 0.001). Intra- and interrater reliability were 0.79 (0.75-0.82) and 0.77 (0.72-0.82), respectively. CONCLUSION: CTMA is more precise than RSA for migration analysis of a tibial implant, has overall good intra- and interrater reliability but higher effective radiation doses in a porcine cadaver.

Early migration of a medially stabilized total knee arthroplasty : a radiostereometric analysis study up to two years.

AIMS: Medial pivot (MP) total knee arthroplasties (TKAs) were designed to mimic native knee kinematics with their deep medial congruent fitting of the tibia to the femur almost like a ball-on-socket, and a flat lateral part. GMK Sphere is a novel MP implant. Our primary aim was to study the migration pattern of the tibial tray of this TKA. METHODS: A total of 31 patients were recruited to this single-group radiostereometric analysis (RSA) study and received a medial pivot GMK Sphere TKA. The distributions of male patients versus female patients and right versus left knees were 21:10 and 17:14, respectively. Mean BMI was 29 kg/m2 (95% confidence interval (CI) 27 to 30) and mean age at surgery was 63 years (95% CI 61 to 66). Maximum total point motions (MTPMs), medial, proximal, and anterior translations and transversal, internal, and varus rotations were calculated at three, 12, and 24 months. Patient-reported outcome measure data were also retrieved. RESULTS: MTPMs at three, 12, and 24 months were 1.0 mm (95% CI 0.8 to 1.2), 1.3 mm (95% CI 0.9 to 1.7), and 1.4 mm (0.8 to 2.0), respectively. The Forgotten Joint Score was 79 (95% CI 39 to 95) and Knee Injury and Osteoarthritis Outcome Score obtained at two years was 94 (95% CI 81 to 100), 86 (95% CI 75 to 93), 94 (95% CI 88 to 100), 69 (95% CI 48 to 88), and 81 (95% CI59 to 100) for Pain, Symptoms, Activities of Daily Living, Sport & Recreation, and Quality of Life, respectively. CONCLUSION: In conclusion, we found that the mean increase in MTPM was lower than 0.2 mm between 12 and 24 months and thus apparently stable. Yet the GMK Sphere had higher migration at one and two years than anticipated. Based on current RSA data, we therefore cannot conclude on the long-term performance of the implant, pending further assessment. Cite this article: Bone Jt Open 2021;2(9):737-744.

Decreased Survival of Medial Pivot Designs Compared with Cruciate-retaining Designs in TKA Without Patellar Resurfacing.

BACKGROUND: The medial pivot TKA design was introduced in the 1990s. These are fixed-bearing, medial-conforming implants with virtually no translation in the medial part of the knee, in contrast to the flat lateral part of the insert allowing for translation similar to the native knee during flexion and extension. Most primary TKAs performed in Norway and Australia are cruciate-retaining. All of the medial pivot implants in our study are cruciate-sacrificing but without a post-cam mechanism. The medial pivot implant design was developed to more closely mimic native knee motion, in the hope of improving function, and not primarily as a more constrained knee for difficult cases. In the past 10 to 12 years, a second-generation medial-pivot design has emerged, but there are no larger registry studies on the survival of these implants. Both cruciate-retaining and medial pivot designs are reported in the Australian and Norwegian registries, allowing for large-scale, comparative survivorship studies. QUESTIONS/PURPOSES: (1) Is there any difference in survival between the medial pivot design and the three most commonly used cruciate-retaining TKA designs? (2) Is there any difference in survival among the different medial pivot implant designs? (3) What are the main indications for revision of medial pivot TKAs? METHODS: Registry data from the Australian Orthopaedic Association National Joint Replacement Registry and Norwegian Arthroplasty Register from 2005 until the end of 2017 were used to compare the five different brands of medial pivot TKA designs (total primary TKAs assessed: 6310). In Australia, the study group of medial pivot implants represented 9% (6012 of 72,477) of the total number of cemented/hybrid TKAs without patellar resurfacing; 345 had cementless femoral components. In Norway, the study group represented 1% (298 of 47,820) of the total number of TKAs with cemented tibias without patellar resurfacing; all had cemented femoral components. The control group consisted of the three most commonly used cruciate-retaining TKA designs (n = 70,870; Australia n = 54,554; Norway n = 16,316). All TKAs used a fixed-bearing, cemented tibial component and did not involve patella resurfacing. Kaplan-Meier survival analysis was assessed to estimate survivorship. We compared the groups by calculating the hazard ratios (HR) using Cox regression adjusted for age, gender and preoperative diagnosis with 95% CI. To answer our third question, we calculated the percentage of each revision indication from the total number of revisions in each group, and used a Cox regression analysis to compare revision causes and HRs. Analyses were performed separately by each registry. Accounting for competing risks (Fine and Gray) did not alter our findings []. RESULTS: After controlling for potential confounding variables such as gender, age and preoperative diagnosis, we found an increased revision risk for the medial pivot compared with cruciate-retaining TKA designs in Australia (HR 1.4 [95% CI 1.2 to 1.7]; p < 0.001), but not in Norway (HR 1.5 [95% CI 0.9 to 2.4]; p = 0.1). Two brands of the medial pivot design reported to the AOANJRR showed an increased risk of revision compared with cruciate-retaining designs: the Advance® II MP (HR 1.7 [95% CI 1.2 to 2.6]; p = 0.004) and the GMK® Sphere (HR 2.0 [95% CI 1.5 to 2.6]; p < 0.001), whereas the MRK (HR 0.7 [95% CI 0.4 to 1.5]; p = 0.4), the Evolution® MP (HR 1.4 [95% CI 1.0 to 1.9]; p = 0.06) and the SAIPH® (HR 0.9 [95% CI 0.5 to 1.5]; p = 0.7) showed no difference. The most common reasons for revision of medial pivot implants in Australia were infection (27%), pain alone (19%), patellar erosion (13%), loosening/lysis (12%); in Norway the primary indications were loosening/lysis (28%), instability (28%), malalignment (11%) and pain alone (11%). CONCLUSIONS: The medial pivot TKA design as a group had a higher revision rate than cruciate-retaining fixed-bearing controls in TKA performed without patellar component resurfacing. By brand, the Advance II MP and the GMK Sphere had inferior survivorship, whereas the MRK, the SAIPH and the Evolution MP had no differences in survivorship compared with cruciate-retaining controls. In Australia, TKAs with the medial pivot design without patella resurfacing had a higher rate of revisions for instability, malalignment, and patella erosion. In Norway, there was an increased risk of revision for lysis and loosening compared with the cruciate-retaining design. Several of these implants had short follow-up in this study. Further registry studies with longer follow up are therefore necessary. LEVEL OF EVIDENCE: Level III, therapeutic study.

A 2-year RSA study of the Vanguard CR total knee system: A randomized controlled trial comparing patient-specific positioning guides with conventional technique.

Background and purpose - There is some concern regarding the revision rate of the Vanguard CR TKA in 1 registry, and the literature is ambiguous about the efficacy of patient-specific positioning guides (PSPGs). The objective of this study was to investigate the stability of the cemented Vanguard CR Total Knee using 2 different surgical techniques. Our hypothesis was that there is no difference in migration when implanting the Vanguard CR with either PSPGs or conventional technique. We hereby present a randomized controlled trial of 2-year follow-up with radiostereometric analysis (RSA). Patients and methods - 40 TKAs were performed between 2011 and 2013 with either PSPGs or the conventional technique and 22 of these were investigated with RSA. Results - The PSPG (8 knees) and the conventional (14 knees) groups had a mean maximum total point motion (MTPM) (95% CI) of 0.83 (0.48-1.18) vs. 0.70 (0.43-0.97) mm, 1.03 (0.60-1.43) vs. 0.86 (0.53-1.19), and 1.46 (1.07-1.85) vs. 0.80 (0.52-1.43) at 3, 12, and 24 months respectively (p = 0.1). 5 implants had either an MTPM >1.6 mm at 12 months and/or a migration of more than 0.2 mm between 1- and 2-year follow-ups. 2 of these also had a peripheral subsidence of more than 0.6 mm at 2 years. Interpretation - 5 implants (3 in the PSPG group) were found to be at risk of later aseptic loosening. The PSPG group continuously migrated between 12 and 24 months. The conventional group had an initial high migration between postoperative and 3 months, but seemed more stable after 1 year. Although the difference was not statistically significant, we think the migration in the PSPG group is of some concern.