Guideline for RSA and CT-RSA implant migration measurements: an update of standardizations and recommendations.

Opening remarks: These guidelines are the result of discussions within a diverse group of RSA researchers. They were approved in December 2023 by the board and selected members of the International Radiostereometry Society to update the guidelines by Valstar et al. [1]. By adhering to these guidelines, RSA studies will become more transparent and consistent in execution, presentation, reporting, and interpretation. Both authors and reviewers of scientific papers using RSA may use these guidelines, summarized in the Checklist, as a reference. Deviations from these guidelines should have the underlying rationale stated.

Osseointegration of minimally invasive sacroiliac joint fixation implants-A human retrieval study.

Minimally invasive sacroiliac joint fusion has become increasingly prevalent and is described to reduce pain and improve function. In some patients, pain can recur several months after primary surgery. Lack of early implant osseointegration might be a cause of pain and hence an indication for revision surgery. Triangular titanium implants are the most documented implant for minimally invasive sacroiliac joint fusion. There is, however, no knowledge of how triangular titanium implants osseointegrate in humans and whether fusion is induced over the sacroiliac joint. During planned revision surgery due to recurrent pain, six triangular titanium implants were retrieved from six different patients at median 9 months from primary surgery. All six implants were scanned using microcomputed tomography. The presence or absence of bone in-growth, on-growth, and through-growth of the implants was evaluated as an indication of implant osseointegration. Three of six implants showed no or minor signs of osseointegration. Of the three remaining implants, one showed partial osseointegration and two implants showed high degrees of osseointegration. This study showed that triangular titanium implants can osseointegrate into host bone in humans. When osseointegration occurs, triangular titanium implants can give fusion across the sacroiliac joint.

The effect of minimally invasive sacroiliac joint fusion compared to sham operation: a double-blind randomized placebo-controlled trial.

Background: Minimally invasive fusion of the sacroiliac joint as treatment for low back pain may reduce pain and improve function compared to non-operative treatment, although clear evidence is lacking. The aim of this trial was to evaluate the effect of minimally invasive sacroiliac joint fusion compared to sham surgery on sacroiliac joint pain reduction. Methods: In this double-blind randomized sham surgery-controlled trial patients with clinical diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection were included at two university hospitals in Sweden and Norway. Patients were randomized by the operating surgeon at each site to minimally invasive sacroiliac joint fusion or sham surgery. The primary endpoint was group difference in sacroiliac joint pain on the operated side at six months postoperatively, measured by the Numeric Rating Scale (0-10). Un-blinding and primary analysis were performed when all patients had completed six months follow-up. The trial is closed for new participants and was registered at clinicaltrials.gov: NCT03507049. Findings: Between September 1st, 2018 and October 22nd, 2021, 63 patients were randomized, 32 to the surgical group, 31 to the sham group. Mean age was 45 years (range 26-63) and 59 of 63 (94%) patients were female. The mean reduction in the operated sacroiliac joint from baseline to six months postoperative was 2.6 Numeric Rating Scale points in the surgical group and 1.7 points in the sham group (mean between groups difference -1.0 points; 95% CI, -2.2 to 0.3; p = 0.13). Interpretation: This double-blind randomized controlled trial could not prove that minimally invasive fusion of the sacroiliac joint was superior to sham surgery at six months postoperative. Funding: Sophies Minde Ortopedi supported a clinical research position for Engelke Marie Randers. Region Stockholm supported the cost for the Swedish ethical application and a clinical research appointment for Paul Gerdhem.

No benefit of the trochanteric stabilizing plate on loss of fracture reduction in AO/OTA 31-A2 trochanteric fractures.

Aims: Despite limited clinical scientific backing, an additional trochanteric stabilizing plate (TSP) has been advocated when treating unstable trochanteric fractures with a sliding hip screw (SHS). We aimed to explore whether the TSP would result in less post operative fracture motion, compared to SHS alone. Methods: Overall, 31 patients with AO/OTA 31-A2 trochanteric fractures were randomized to either a SHS alone or a SHS with an additional TSP. To compare postoperative fracture motion, radiostereometric analysis (RSA) was performed before and after weightbearing, and then at four, eight, 12, 26, and 52 weeks. With the "after weightbearing" images as baseline, we calculated translations and rotations, including shortening and medialization of the femoral shaft. Results: Similar migration profiles were observed in all directions during the course of healing. At one year, eight patients in the SHS group and 12 patients in the TSP group were available for analysis, finding a clinically non-relevant, and statistically non-significant, difference in total translation of 1 mm (95% confidence interval -4.7 to 2.9) in favour of the TSP group. In line with the migration data, no significant differences in clinical outcomes were found. Conclusion: The TSP did not influence the course of healing or postoperative fracture motion compared to SHS alone. Based on our results, routine use of the TSP in AO/OTA 31-A2 trochanteric fractures cannot be recommended. The TSP has been shown, in biomechanical studies, to increase stability in sliding hip screw constructs in both unstable and intermediate stable trochanteric fractures, but the clinical evidence is limited. This study showed no advantage of the TSP in unstable (AO 31-A2) fractures in elderly patients when fracture movement was evaluated with radiostereometric analysis.

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.

A novel instrument for ligament balancing: a biomechanical study in human cadaveric knees.

PURPOSE: Ligament balancing is a prerequisite for good function and survival in total knee arthroplasty (TKA). Various balancing techniques exist, but none have shown superior results. The pie-crusting technique by Bellemans of the medial collateral ligament is commonly utilized; however, it can be difficult to achieve repeatable ligament lengthening with this technique. Therefore, we invented a novel instrument to standardize the pie-crusting technique of the superficial and deep medial collateral ligament (hereafter MCL). The purpose was to examine if pie-crusting with the instrument could produce repeatable ligament lengthening. METHODS: The MCL was isolated in 16 human cadaveric knees, and subjected to axial tension. The instrument was composed of a specific grid of holes in rows, used to guide sequential pie-crusting puncturing of the MCL with a Ø1.6 mm end-cutting cannula. Ligament lengthening was measured after each row of punctures. Regression analysis was performed on the results. RESULTS: Mean lengthening ± SD in human cadaveric MCL for puncturing of row 1 in the instrument was 0.06 ± 0.09 mm, 0.06 ± 0.04 mm for row 2, 0.09 ± 0.08 mm for row 3, 0.06 ± 0.05 mm for row 4 and 0.06 ± 0.04 mm for row 5, giving a mean total lengthening of 0.33 ± 0.20 mm. Linear regression revealed that MCLs were repeatably lengthened by 0.07 mm per row when punctured using the instrument. CONCLUSIONS: MCLs showed linear lengthening in human cadavers for subsequent use of the instrument. Our instrument shows promising results for repeatable ligament lengthening.

Effects of patient-specific positioning guides (PSPGs) vs. conventional instrumentation on patient-reported outcome in total knee arthroplasty: secondary analysis of a randomized controlled trial after 5 years.

BACKGROUND AND PURPOSE: The use of patient-specific positioning guides (PSPGs) in total knee arthroplasty (TKA) has been advocated as a means of improving patient outcomes, but the reception of PSPGs has been mixed. The aim of our study was to compare patient-reported outcomes (KOOS, NRS-11, EQ-5D-3L, EQ-VAS) after TKA using PSPG with conventional instrumentation (CI) to determine whether there is a discernible clinical benefit to using PSPGs. PATIENTS AND METHODS: This multicenter randomized controlled trial (RCT) followed 77 patients who were randomly assigned to 1 of 2 cohorts between September 2011 and January 2014-one receiving TKA with PSPGs (from Materialise NV) and one receiving TKA with CI-with each cohort followed up until 5 years after the operation. The Vanguard Cruciate Retaining Total Knee System and Refobacin Bone Cement R were used in all operations. KOOS was evaluated using confidence intervals, with differences of less than 10 KOOS units between the cohorts interpreted as indicating the absence of a clinically meaningful difference. RESULTS: No significant differences were found in any of the measured clinical outcomes-KOOS, NRS-11, EQ-5D-3L, EQ-VAS, range of motion, or radiolucent lines scoring-between the cohort operated on using PSPG and the cohort operated on using CI after 5 years of follow-up. CONCLUSION: There was no statistically significant effect of PSPGs on patient-reported outcomes or range of motion in TKA.

CT-based radiostereometric analysis for assessing midfoot kinematics: precision compared with marker-based radiostereometry.

BACKGROUND AND PURPOSE: 3-dimensional midfoot motion is hard to evaluate in clinical practice. We present a new computed tomography (CT)-based radiostereometric analysis (CT-RSA) technique to examine in vivo midfoot kinematics during single-leg stance and compare it with marker-based radiostereometry (RSA). PATIENTS AND METHODS: 8 patients were examined with bilateral non- and full-weight-bearing CT images of the midfoot. 1st tarsometatarsal motion was analyzed using a surface-registration technique (CT-RSA). As all patients had unilateral tantalum markers in the 1st cuneiform (C1) and 1st metatarsal (M1), comparison of precision with markerbased RSA was performed. CT-RSA precision was evaluated with surface registration of both C1-M1 bone and C1-M1 tantalum markers, while RSA precision was determined with C1-M1 markers only. Additionally, to remove motion bias, we evaluated intrasegmental CT-RSA precision by comparing proximal with distal part of M1. RESULTS: Under physical load, the primary movement for the 1st tarsometatarsal joint was M1 dorsiflexion (mean 1.4°), adduction (mean 1.4°), and dorsal translation (mean 1.1 mm). CT-RSA precision, using surface bone or markers, was in the range of 0.3-0.7 mm for translation and 0.6-1.6° for rotation. In comparison, RSA precision was in the range of 0.4-0.9 mm for translation and 1.0-1.7° for rotation. Finally, intrasegmental CT-RSA precision was in the range of 0.1-0.2 mm for translation and 0.4-0.5° for rotation. CONCLUSION: CT-RSA is a valid and precise, non-invasive method to measure midfoot kinematics when compared with conventional RSA.

Computed tomography-based radiostereometric analysis in orthopedic research: practical guidelines.

Early implant migration is an indicator of the long-term survival/failure of implants. CT-based radio-stereometric analysis (CT-RSA) is a precise method for measuring and visualizing implant migration in vivo using image processing of CT scans. This makes the method widely applicable to orthopedic researcher. Since its development in the early 2000s, CT-RSA has benefited from breakthroughs in CT and computing technology. These advancements have allowed for the acquisition of images with higher resolution at a much lower radiation dose. As a result, the measurement precision of CT-RSA is now comparable to that of the current gold standard technology while still compatible with most ethical considerations regarding radiation exposure. In this review we present bests practices for the successful execution of CT-RSA research projects. These practices are based on experience from projects on the hip, knee, shoulder, lower back, cervical spine, foot, pelvis, and wrist.

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.

Does temporary bridge plate fixation preserve joint motion after an unstable Lisfranc injury?

BACKGROUND: Recently, temporary bridge plate fixation has gained popularity in the treatment of unstable Lisfranc injuries. The technique aims to reduce the risk of posttraumatic osteoarthritis, and after plate removal, the goal is to regain joint mobility. Here we explore marker-based radiostereometric analysis (RSA) to measure motion in the 1st tarsometatarsal (TMT) joint and asses the radiological outcome in patients treated with this surgical technique. METHOD: Ten patients with an unstable Lisfranc injury were included. All were treated with a dorsal bridge plate over the 1st TMT joint and primary arthrodesis of the 2nd and 3rd TMT joints. The plate was removed four months postoperatively. Non- and weight-bearing RSA images were obtained one and five years postinjury to assess joint mobility and signs of osteoarthritis. RESULTS: Detectable 1st TMT joint motion was observed in 2/10 patients after one year, and 6/9 patients after five years. At the final follow-up, mean 1st TMT dorsiflexion was 2.0°. Radiologically, the incidence of posttraumatic osteoarthritis was present in 4/10 patients after one year, and 5/9 patients after five years. All patients had observed TMT joint stability throughout the follow-up period. CONCLUSION: Preservation of joint motion can be achieved with a temporary bridge plate fixation over the 1st TMT joint. TYPE OF STUDY/LEVEL OF EVIDENCE: Prospective cohort study/Therapeutically level IV.

Comparison of the in-vivo kinematics of three different knee prosthesis designs during a step-up movement.

BACKGROUND: There is no consensus on the importance of the kinematics of the prosthetic joint for the clinical outcome after total knee arthroplasty. A 3-armed randomized controlled trial was done to determine and compare the in vivo kinematics of a posterior cruciate-retaining and two posterior cruciate-sacrificing (Anterior-Stabilized and Posterior-Stabilized) prosthetic designs from the same total knee arthroplasty system. Since the anterior-stabilized and posterior-stabilized designs are posterior cruciate ligament-sacrificing designs, we hypothesized they would have similar contact-point kinematics. Further, we hypothesized that the cruciate-retaining design would have contact-point kinematics different from the anterior-stabilized and the posterior-stabilized designs, but comparable to a native knee. METHODS: Thirty-nine patients with a well-functioning total knee arthroplasty one year postoperatively underwent kinematic analysis of a weight-bearing step-up movement under fluoroscopic recording. Model-based radiostereometric analysis was used to determine anteroposterior contact-point translations and rotations through the movement path to assess knee kinematics. FINDINGS: The cruciate-retaining and anterior-stabilized groups' medial and lateral contact-points displayed similar paradoxical posterior translations during step-up in the magnitude of 7 and 2 mm, respectively. In contrast, the posterior-stabilized group's contact-points translated anteriorly by 4 and 10 mm throughout the movement and were significantly more posterior than the cruciate-retaining and the anterior-stabilized groups from >100° to 40° of flexion. The femur rotated internally with all designs. INTERPRETATION: The cruciate-retaining and anterior-stabilized designs displayed similar contact-point translation patterns during a step-up movement. Only the posterior-stabilized design showed a pattern comparable to native knees. Conversion from a cruciate-retaining to an anterior-stabilized design because of posterior cruciate ligament insufficiency will not change knee kinematics.

A randomized controlled trial comparing two modern total wrist arthroplasties : improved function with stable implants, but high complication rates in non-rheumatoid wrists at two years.

AIMS: To analyze the short-term outcome of two types of total wrist arthroplasty (TWA) in terms of wrist function, migration, and periprosthetic bone behaviour. METHODS: A total of 40 patients suffering from non-rheumatoid wrist arthritis were enrolled in a randomized controlled trial comparing the ReMotion and Motec TWAs. Patient-rated and functional outcomes, radiological changes, blood metal ion levels, migration measured by model-based radiostereometric analysis (RSA), bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA), complications, loosening, and revision rates at two years were compared. RESULTS: Patient-Rated Wrist and Hand Evaluation (PRWHE) scores, abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire scores, and pain improved similarly and significantly in both groups. Wrist motion improved significantly in the Motec group only, and forearm rotation in the ReMotion group only. Cobalt (Co) and chromium (Cr) blood ion levels were significantly higher in the metal-on-metal (MoM) Motec group than in the metal-on-polyethylene (MoP) ReMotion group. Mean total translation was 0.65 mm (95% confidence interval (CI) 0.26 to 1.12) and 0.27 mm (95% CI 0.14 to 0.47) for the ReMotion carpal and radial components, and 0.32 mm (95% CI 0.22 to 0.45) and 0.26 mm (95% CI 0.20 to 0.34) for the Motec metacarpal and radial components, respectively. Apart from dorsal and volar tilts, which were significantly higher for the radial ReMotion than for the Motec component, no significant differences in absolute migration occurred. BMD around the radial components never returned to baseline. Almost one-third of patients required reoperation due to complications. Two ReMotion implants were revised to Motec TWAs due to carpal component loosening, and three Motec MoM articulations were revised to metal-on-polyether ether ketone due to painful synovitis. CONCLUSION: Both implants provided matched function and were stable at short-term follow-up, but with a high complication rate. This procedure should be restricted to specialist centres undertaking prospective analysis until its role is clarified.Cite this article: Bone Joint J 2022;104-B(10):1132-1141.

Risk factors for revision surgery due to dislocation within 1 year after 111,711 primary total hip arthroplasties from 2005 to 2019: a study from the Norwegian Arthroplasty Register.

BACKGROUND AND PURPOSE: Dislocation of a hip prosthesis is the 3rd most frequent cause (after loosening and infection) for hip revision in Norway. Recently there has been a shift in surgical practice including preferred head size, surgical approach, articulation, and fixation. We explored factors associated with the risk of revision due to dislocation within 1 year and analyzed the impact of changes in surgical practice. PATIENTS AND METHODS: 111,711 cases of primary total hip arthroplasty (THA) from the Norwegian Arthroplasty Register were included (2005-2019) after primary THA with either 28 mm, 32 mm, or 36 mm femoral heads, or dualmobility articulations. A flexible parametric survival model was used to calculate hazard ratios for risk factors. Kaplan-Meier survival rates were calculated. RESULTS: There was an increased risk of revision due to dislocation with 28 mm femoral heads (HR 2.6, 95% CI 2.0-3.3) compared with 32 mm heads. Furthermore, there was a reduced risk of cemented fixation (HR 0.6, CI 0.5-0.8) and reverse hybrid (HR 0.6, CI 0.5-0.8) compared with uncemented. Also, both anterolateral (HR 0.5, CI 0.4-0.7) and lateral (HR 0.6, CI 0.5-0.7) approaches were associated with a reduced risk compared with the posterior approach. The time-period 2010-2014 had the lowest risk of revision due to dislocation. The trend during the study period was towards using larger head sizes, a posterior approach, and uncemented fixation for primary THA. INTERPRETATION: Patients with 28 mm head size, a posterior approach, or uncemented fixation had an increased risk of revision due to dislocation within 1 year after primary THA. The shift from lateral to posterior approach and more uncemented fixation was a plausible explanation for the increased risk of revision due to dislocation observed in the most recent time-period. The increased risk of revision due to dislocation was not fully compensated for by increasing femoral head size from 28 to 32 mm.

Stable glenoid component of reverse total shoulder arthroplasty at 2 years as measured with model-based radiostereometric analysis (RSA).

Background and purpose - Reverse total shoulder arthroplasty (TSA) is used for treating cuff arthropathy, displaced proximal humeral fractures (PHF), and in revision shoulder surgery, despite sparse evidence on long-term results. We assessed stability of the glenoid component in reverse TSA, using model-based RSA.Patients and methods - 20 patients (mean age 76 years, 17 female), operated on with reverse TSA at Oslo University Hospital, in 2015-2017 were included. Indications for surgeries were PHFs, malunion, cuff arthropathy, and chronic shoulder dislocation. RSA markers were placed in the scapular neck, the coracoid, and the acromion. RSA radiographs were conducted postoperatively, at 3 months, 1 year, and 2 years. RSA analysis was performed using RSAcore with Reversed Engineering (RE) modality, with clinical precision < 0.25 mm for all translations (x, y, z) and < 0.7° for rotations (x, z). Scapular "notching" was assessed in conventional radiographs.Results - 1 patient was excluded due to revision surgery. More than half of the patients displayed measurable migration at 2 years: 6 patients with linear translations below 1 mm and 8 patients who showed rotational migration. Except for one outlier, the measured rotations were below 2°. The migration pattern suggested implant stability at 2 years. 10 patients showed radiolographic signs of "notching", and the mean Oxford Shoulder Score (OSS) at 2 years was 29 points (15-36 points).Interpretation - Stability analysis of the glenoid component of reversed total shoulder arthroplasty using reversed engineering (RE) model-based RSA indicated component stability at 2 years.

Hip disorders in children and adolescents ­ assessment and treatment of sequelae. / Hoftelidelser hos barn og unge ­ utredning og behandling av senfølger.

The consequences of hip disorders and hip injuries in children and adolescents may require surgical intervention. Joint-preserving procedures performed between the ages of 12 and 21 years often give good long-term results and may postpone the need for prostheses. In patients aged less than 21 years, more than 90 % of modern hip prostheses implanted in the last two decades are intact after ten years.

Results of a randomized controlled trial with five-year radiostereometric analysis results of vitamin E-infused highly crosslinked versus moderately crosslinked polyethylene in reverse total hip arthroplasty.

AIMS: Vitamin E-infused highly crosslinked polyethylene (VEPE) has been introduced into total hip arthroplasty (THA) with the aim of further improving the wear characteristics of moderately and highly crosslinked polyethylenes (ModXLPE and HXLPE). There are few studies analyzing the outcomes of vitamin E-infused components in cemented arthroplasty, though early acetabular component migration has been reported. The aim of this study was to measure five-year polyethylene wear and acetabular component stability of a cemented VEPE acetabular component compared with a ModXLPE cemented acetabular component. METHODS: In a prospective randomized controlled trial (RCT), we assessed polyethylene wear and acetabular component stability (primary outcome) with radiostereometric analysis (RSA) in 68 patients with reverse hybrid THA at five years follow-up. Patients were randomized to either a VEPE or a ModXLPE cemented acetabular component. RESULTS: Mean polyethylene wear in the proximal direction was 0.17 mm (SD 0.15) for the VEPE group and 0.20 mm (SD 0.09) for the ModXLPE group (p = 0.005) at five years. Annual proximal wear rates were 0.03 mm/year (VEPE) and 0.04 mm/year (ModXLPE). Total 3D wear was 0.21 mm (SD 0.26) and 0.23 mm (SD 0.10) for the VEPE and ModXLPE groups, respectively (p = 0.009). Total 3D cup translation was 0.72 mm (SD 0.70) (VEPE) and 0.50 mm (SD 0.44) (ModXLPE) (p = 0.409). CONCLUSION: At five years, there was less polyethylene wear in the VEPE group than in the ModXLPE group. Both VEPE and ModXLPE cemented components showed low annual wear rates. Component stability was similar in the two groups and remained constant up to five years. Whether these results will equate to a lower long-term revision rate is still unknown. Cite this article: Bone Joint J 2020;102-B(12):1646-1653.

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.

Component Placement in Direct Lateral vs Minimally Invasive Anterior Approach in Total Hip Arthroplasty: Radiographic Outcomes From a Prospective Randomized Controlled Trial.

BACKGROUND: End-stage coxarthrosis is increasingly common; however, limited evidence exists on the effect of direct lateral approach (DLA) and minimally invasive direct anterior approach (MIDA) on component placement in total hip arthroplasty (THA). We therefore conducted a prospective, randomized controlled trial to determine the component placement in DLA vs MIDA in THA. METHODS: Between January 2012 and June 2013, 164 patients with clinically and radiologically confirmed coxarthrosis aged 20-80 years were randomized to either DLA or MIDA (active comparator). Excluded were patients with previous ipsilateral hip surgery, a body mass index >35 kg/m2, and/or mental disability. Primary clinical outcomes have been published elsewhere. Secondary outcomes included radiographic assessment of the acetabular component (cement-mantle thickness, inclination, and anteversion), femoral stem position (varus/valgus and THA index), offset restoration, and leg length discrepancy. RESULTS: The mean cement-mantle was significantly thicker in zone 1 in the MIDA group (mean difference = 0.51 mm, 95% confidence interval [CI] 0.09-0.93, P = .018), and the mean degrees of inclination and anteversion were higher in the MIDA group (mean difference = 2.5°, 95% CI 0.3-4.6, P = .023 and mean difference = 3.6°, 95% CI 2.2-5.0, P < .0001, respectively). According to the defined reference range, cup inclination was more often adequate in the DLA group (67.9% (53/78) in the DLA group vs 52.4% (43/82) in the MIDA group, P = .045). There were no differences in frontal or lateral femoral stem position, global offset restoration, or leg length discrepancy. CONCLUSION: In this population of Norwegian patients with coxarthrosis, radiographic assessment showed limited differences in component placement between MIDA and DLA. The findings suggest that component placement is similar in the 2 surgical approaches.