Fenestrated Endovascular Repair With Large Device Diameters (34-36 mm) is Associated With Type 1 and 3 Endoleak and Reintervention.

BACKGROUND: Patients with abdominal aortic aneurysms undergoing EVAR with larger device diameters (34-36 mm) have worse outcomes due to proximal fixation failure and need for reintervention. We examine outcomes relating to standard fenestrated repair (FEVAR) with larger device diameters, and investigate whether a similar relationship exists. METHODS: Retrospective review of a prospectively maintained, single institution database of patients treated with the Cook ZFEN device between 2012-2017. Outcomes were stratified by device diameter into normal-diameter (ND,≤ 32 mm) and large-diameter (LD,34-36 mm). Primary endpoints were need for reintervention and composite type I/III endoleak. RESULTS: One-hundred consecutive patients treated were identified for inclusion. Overall mean age was 73.6 years and mean aortic diameter was 59.1 mm. Mean follow-up was 22 months. A total of 26 (26%) patients were treated with LD devices. Number of target vessels per patient was 2.8 in both groups. Infrarenal neck length and diameter were significantly different in the LD and ND patients, respectively (2.6 mm vs. 4.7 mm (P < 0.01) and 30.1 mm vs. 23.4 mm (P < 0.01)). Percent graft oversizing was lower in the LD cohort (19% vs. 24%; P = 0.006). No difference was seen in overall mortality at 30-days (0% vs. 2%; P = 0.4) or at latest follow up (6% vs. 14%; P = 0.6). Reinterventions were not significantly different at 30 days, but were significantly higher over the follow-up period in the LD cohort (46.2 vs. 17.6%; P = 0.002). LD diameter was associated with reintervention on univariate (HR 1.19, 95% CI 1.04-1.37), but not multivariate analysis. The composite endpoint of type I/III endoleak was higher in the LD cohort (15.4% vs. 2.7%; P = 0.004). CONCLUSIONS: FEVAR requiring 34- or 36-mm device diameters is associated with an increased risk of composite type I/III endoleak and reintervention. Patients undergoing fenestrated repair requiring LD devices should be closely monitored, with consideration for proximal or open repair.

Reduction of stent-associated morbidity by minimizing stent material: a prospective, randomized, single-blind superiority trial assessing a customized 'suture stent'.

OBJECTIVES: To compare a customized 'suture stent' with a standard ureteric stent regarding stent-related symptoms, safety and efficacy. MATERIALS AND METHODS: Patients with urolithiasis located proximal to the iliac vessel crossing, requiring stenting in preparation for secondary ureterorenoscopy (URS) were randomized to standard ureteric stenting or a suture stent. Secondary ureterorenoscopy was performed 2-6 weeks later. The Ureteral Stent Symptoms Questionnaire (USSQ) was completed after 1 week, on the day before URS and 2-6 weeks after stent removal. Stent efficacy and safety were systematically assessed. RESULTS: A total of 88 patients were included in the analysis. The median (range) suture stent length was 10 (5-25) cm vs 26 cm for standard stents. Operation time was longer for insertion of the suture stent (24.0 vs 14.5 min; P < 0.001). Patients with a suture stent had a significantly lower USSQ urinary symptoms score 1 week after stent insertion, adjusted for baseline symptoms by subtracting scores from the final visit without indwelling stent (mean 7.1 vs 13.7, difference -6.6, 95% confidence interval [CI] -3.4 to -9.8; P < 0.001). Prior to secondary URS (after 2-6 weeks), baseline-adjusted urinary symptoms (mean 4.7 vs 12.2, difference -7.5, 95% CI -4.5 to -10.4; P < 0.001) and pain subscores (11.5 vs 17.6, difference -6.1, 95% CI -0.7 to -11.6; P = 0.004) were significantly lower in the suture stent group. All other USSQ subscores showed no significant differences. Adverse events occurred in 15 patients and were similarly frequent in the two groups. No significant differences were found between the groups regarding ureteric access during secondary URS. CONCLUSION: Replacement of the distal part of ureteric stents by a suture can reduce stent-associated symptoms without restrictions regarding secondary stone removal or safety.

"Pumpology": the Realistic Issues Associated with Pump Placement in Prosthetic Surgery.

PURPOSE OF REVIEW: The goal of this paper was to discuss the issues and/or overt complications associated with the 3-piece inflatable penile prosthesis (3-IPP) pump. We also addressed how to resolve such issues with or without surgical intervention. RECENT FINDINGS: Numerous modifications of the 3-IPP pump have been introduced with multiple techniques to place the pump. These are largely dependent on the approach to place the 3-IPP. Pump issues may inevitably occur, and there are numerous special maneuvers that can be performed to resolve pump issues. It is important for urologists to know maneuvers for pump malfunctions to prevent unnecessary surgical procedures and pump revision. Several studies are reviewed regarding pump issues and patient satisfaction; however, a more structured prospective research project is warranted to further evaluate these issues.

Are Damage Modes Related to Microstructure and Material Loss in Severely Damaged CoCrMo Femoral Heads?

BACKGROUND: Fretting and corrosion in metal-on-polyethylene total hip arthoplasty (THA) modular junctions can cause adverse tissue reactions that are responsible for 2% to 5% of revision surgeries. Damage within cobalt-chromium-molybdenum (CoCrMo) alloy femoral heads can progress chemically and mechanically, leading to damage modes such as column damage, imprinting, and uniform fretting damage. At present, it is unclear which of these damage modes are most detrimental and how they may be linked to implant alloy metallurgy. The alloy microstructure exhibits microstructural features such as grain boundaries, hard phases, and segregation bands, which may enable different damage modes, higher material loss, and the potential risk of adverse local tissue reactions. QUESTIONS/PURPOSES: In this study, we asked: (1) How prevalent is chemically dominated column damage compared with mechanically dominated damage modes in severely damaged metal-on-polyethylene THA femoral heads made from wrought CoCrMo alloy? (2) Is material loss greater in femoral heads that underwent column damage? (3) Do material loss and the presence of column damage depend on alloy microstructure as characterized by grain size, hard phase content, and/or banding? METHODS: Surgically retrieved wrought CoCrMo modular femoral heads removed between June 2004 and June 2019 were scored using a modified version of the Goldberg visually based scoring system. Of the total 1002 heads retrieved over this period, 19% (190 of 1002) were identified as severely damaged, exhibiting large areas of fretting scars, black debris, pits, and/or etch marks. Of these, 43% (81 of 190) were excluded for metal-on-metal articulations, alternate designs (such as bipolar, dual-mobility, hemiarthroplasty, metal adaptor sleeves), or previous sectioning of the implant for past studies. One sample was excluded retroactively as metallurgical analysis revealed that it was made of cast alloy, yielding a total of 108 for further analysis. Information on patient age (57 ± 11 years) and sex (56% [61 of 108] were males), reason for removal, implant time in situ (99 ± 78 months), implant manufacturer, head size, and the CoCrMo or titanium-based stem alloy pairing were collected. Damage modes and volumetric material loss within the head tapers were identified using an optical coordinate measuring machine. Samples were categorized by damage mode groups by column damage, imprinting, a combination of column damage and imprinting, or uniform fretting. Metallurgical samples were processed to identify microstructural characteristics of grain size, hard phase content, and banding. Nonparametric Mann-Whitney U and Kruskal-Wallis statistical tests were used to examine volumetric material loss compared with damage mode and microstructural features, and linear regression was performed to correlate patient- and manufacturer-specific factors with volumetric material loss. RESULTS: Chemically driven column damage was seen in 48% (52 of 108) of femoral heads, with 34% (37 of 108) exhibiting a combination of column damage and imprinting, 12% (13 of 108) of heads displaying column damage and uniform fretting, and 2% (2 of 108) exhibiting such widespread column damage that potentially underlying mechanical damage modes could not be verified. Implants with column damage showed greater material loss than those with mechanically driven damage alone, with median (range) values of 1.2 mm3 (0.2 to 11.7) versus 0.6 mm3 (0 to 20.7; p = 0.03). Median (range) volume loss across all femoral heads was 0.9 mm3 (0 to 20.7). Time in situ, contact area, patient age, sex, head size, manufacturer, and stem alloy type were not associated with volumetric material loss. Banding of the alloy microstructure, with a median (range) material loss of 1.1 mm3 (0 to 20.7), was associated with five times higher material loss compared with those with a homogeneous microstructure, which had a volume loss of 0.2 mm3 (0 to 4.1; p = 0.02). Hard phase content and grain size showed no correlation with material loss. CONCLUSION: Chemically dominated column damage was a clear indicator of greater volume loss in this study sample of 108 severely damaged heads. Volumetric material loss strongly depended on banding (microstructural segregations) within the alloy. Banding of the wrought CoCrMo microstructure should be avoided during the manufacturing process to reduce volumetric material loss and the release of corrosion products to the periprosthetic tissue. CLINICAL RELEVANCE: Approximately 30% of THAs rely on wrought CoCrMo femoral heads. Most femoral heads in this study exhibited a banded microstructure that was associated with larger material loss and the occurrence of chemically dominated column damage. This study suggests that elimination of banding from the alloy could substantially reduce the release of implant debris in vivo, which could potentially also reduce the risk of adverse local tissue reactions to implant debris.

Adverse Local Tissue Reactions are Common in Asymptomatic Individuals After Hip Resurfacing Arthroplasty: Interim Report from a Prospective Longitudinal Study.

BACKGROUND: The evaluation of the natural history prevalence of adverse local tissue reactions (ALTRs) using MRI has focused only on metal-on-metal (MoM) bearing surfaces without comparison to nonMoM bearing surfaces. QUESTIONS/PURPOSES: To determine (1) the longitudinal changes and differences in blood metal ion levels in patients with hip resurfacing arthroplasty (HRA), ceramic-on-ceramic (CoC) THA, and metal-on-polyethylene (MoP) THA compared with those undergoing ceramic-on-polyethylene (CoP) THA; (2) how the longitudinal change of synovial reaction classification in patients with HRA, CoC THA, and MoP THA compares with those undergoing CoP THA, and whether there is an association between the presence of an ALTR or metallosis on MRI with corresponding patient-reported outcomes, or the presence of capsular dehiscence; and (3) differences in blood metal ion levels between patients undergoing HRA with an ALTR or metallosis on MRI and those with HRA without these conditions. METHODS: Between March 2014 and February 2019, 22,723 patients underwent primary HRA and THA at one center. Patients received an HRA based on their desired athletic level after surgery and the presence of normal acetabular and proximal femoral bone morphology without osteopenia or osteoporosis. Two percent (342 of 22,723) of patients were contacted to participate, and 71% (243 of 342 hips in 206 patients) were enrolled for analysis at baseline. The patients underwent arthroplasty for degenerative joint disease, and 25 patients withdrew over the course of the study. We included patients who were more than 1 year postarthroplasty. All participants had an MRI examination and blood serum ion testing and completed a Hip Disability and Osteoarthritis Outcome Score survey annually for four years (baseline, year 1, year 2, year 3). Morphologic and susceptibility-reduced MR images were evaluated by a single radiologist not involved in the care of patients for the presence and classification of synovitis (Gwet AC1: 0.65 to 0.97), synovial thickness, and volume (coefficient of repeatability: 1.8 cm3). Linear mixed-effects models were used to compare the mean synovial thickness, synovial volume, and Hip Disability and Osteoarthritis Outcome Score subscales between bearing surfaces at each timepoint and within each bearing surface over time. Marginal Cox proportional hazards models were used to compare the time to and the risk of developing ALTR only, metallosis only, and ALTR or metallosis between bearing surfaces. All models were adjusted for age, sex, BMI, and length of implantation based on known confounders for hip arthroplasty. Adjustment for multiple comparisons was performed using the Dunnett-Hsu method. RESULTS: Patients with unilateral HRA had higher cobalt and chromium serum ion levels (baseline: 1.8 ± 0.8 ppb, year 1: 2.0 ± 1.5 ppb, year 2: 2.1 ± 1.2 ppb, year 3: 1.6 ± 0.7 ppb) than those with unilateral CoP bearings (baseline: 0.0 ± 0.1 ppb, year 1: 0.1 ± 0.3 ppb, year 2: 0.0 ± 0.2 ppb, year 3: 0.0 ± 0.0 ppb) at all timepoints (p < 0.001 for each time point). More patients who received an HRA developed ALTR or metallosis on MRI than did patients with CoP bearings (hazard ratio 4.8 [95% confidence interval 1.2 to 18.4]; p = 0.02). There was no association between the longitudinal change of synovial reaction to ALTR or metallosis on MRI with patient-reported outcomes. In addition, there was no association between the presence of dehiscence at baseline and the subsequent development of ALTR or metallosis, as seen on MRI. There were elevated cobalt (4.7 ± 3.5 ppb) and chromium (4.7 ± 2.6 ppb) serum levels in patients with unilateral HRA who had an ALTR or metallosis present on MRI at year 1 compared with patients without an ALTR or metallosis on MRI (cobalt: 1.8 ± 1.0 ppb, mean difference 4.7 ppb [95% CI 3.3 to 6.0]; p < 0.001; chromium: 2.3 ± 0.5 ppb, mean difference 3.6 ppb [95% CI 2.2 to 5.0]; p < 0.001) as well as for chromium at year 3 (3.9 ± 2.4 ppb versus 2.2 ± 1.1 ppb, mean difference 1.3 ppb [95% CI 0.3 to 2.4]; p = 0.01). CONCLUSION: We found a higher proportion of ALTR or metallosis on MRI in patients with HRA compared with patients with CoP, even when patient self-assessed symptomatology of those with an ALTR or metallosis on MRI was not different than the absence of these features. MRI detected ALTRs in high-function patients, emphasizing that an annual clinical assessment dependent on survey or blood ion testing alone may not detect soft tissue complications. The results of this study are in line with prior consensus recommendations of using MRI as part of a routine follow-up protocol for this patient population. LEVEL OF EVIDENCE: Level III, therapeutic study.

The influence of bearing surfaces on revisions due to dislocations in total hip arthroplasty.

INTRODUCTION: Recurrent dislocations are still the most frequent reason for revision in total hip arthroplasty (THA). The impact of bearing surfaces on dislocations is still controversial. We hypothesized that: (1) bearing surfaces influence the revisions due to dislocations; (2) ceramic-on-ceramic reduced the revisions for dislocations in adjusted models; (3) Delta-on-Delta bearings reduced the revisions for dislocations in comparison to surfaces with cross-linked polyethylene. MATERIALS AND METHODS: The regional arthroplasty registry was enquired about bearing surfaces and revisions for dislocations and instability. Unadjusted and adjusted rates were provided, including sex, age (<65 years or ≥65 years), head diameter (≤28 mm or >28 mm; <36 mm or ≥36 mm) as variables. 44,065 THAs were included. RESULTS: The rate of revisions for dislocations was significantly lower in ceramic-on-ceramic and metal-on-metal bearings (unadjusted rates). After adjusting for age, sex, and head size (36 and 28 mm), hard-on-hard bearings were protective (p < 0.05): ceramic-on-ceramic had a lower risk of revisions due to dislocation than ceramic-on-polyethylene (HR 1.6, 95% CI 1.2-2.2 p = 0.0009). The rate of revisions for dislocation was similar in bearings with cross-linked polyethylene and Delta-on-Delta articulations, in unadjusted and adjusted models. CONCLUSION: Bearings with conventional polyethylene were more predisposed to dislocations. Currently adopted bearings exerted no significant influence on revisions due to dislocations. These findings could be primarily related to wear, but due to the time distribution, soft tissue envelopes and surface tension may also play a role. Pre-clinical biomechanical evaluations and prospective matched cohort studies are required to draw definitive conclusions.

Impact of Coronary Stent Design in Proximal Balloon Edge Dilation Technique for Bifurcation Percutaneous Coronary Intervention.

The proximal optimizing technique (POT) -proximal balloon edge dilation (PBED) sequence for side branch (SB) dilatation with cross-over single-stent implantation decreases both strut obstruction at the SB ostium and stent deformation at the main branch (MB).The purpose of this experimental bench test was to assess the impact of stent design on stent deformation, obstruction by stent struts at a jailed SB ostium, and stent strut malapposition in the POT-PBED sequence.Fractal coronary bifurcation bench models (60- and 80-degree angles) were used, and crossover single-stent implantation (3-link stent: XIENCE Sierra, Abbott Vascular, Santa Clara, CA, n = 10; 2-link stent: Synergy, Boston Scientific, Marlborough, MA, n = 10) was performed from the MB using the POT-PBED sequence. Jailing rates at the SB ostium, stent deformation, and stent strut malapposition of the bifurcation segment were assessed using videoscopy and optical coherence tomography.After SB dilatation using the PBED technique, jailing rates at the SB ostium and stent deformation did not differ significantly between the two types of stents. Conversely, the rate of malapposed struts of the bifurcation segment after the PBED procedure was significantly lower with 3-link stents than with 2-link stents for both 60- and 80-degree angles (60-degree angle: 4.3% ± 4.4% versus 22.0% ± 11.1%, P = 0.044; 80-degree angle: 20.8% ± 15.1% versus 57.2% ± 17.0%, P < 0.001, respectively).In the POT-PBED sequence, 3-link stents might be a preferable coronary bifurcation stent, maintaining a jailed SB ostium while significantly reducing stent strut malapposition of the bifurcation segment when compared with 2-link stents.

Damage patterns in polyethylene fixed bearings of retrieved total ankle replacements.

INTRODUCTION: Poor long-term outcomes continue to hinder the universal adoption of total ankle replacements (TAR) for end stage arthritis. In the present study, polyethylene inserts of TARs retrieved at revision surgery were analyzed for burnishing, scratching, mechanical damage, pitting, and embedded particles. METHODS: Fourteen retrieved polyethylene inserts from a fixed bearing total ankle replacement design currently in clinical use were analyzed. Duration of time in vivo was between 11.5 months and 120.1 months. Three investigators independently graded each articular surface in quadrants for five features of damage: burnishing, scratching, mechanical damage, pitting, and embedded particles. RESULTS: No correlation was found for burnishing between the anterior and posterior aspects (p = 0.47); however, scratching and pitting were significantly higher on the posterior aspect compared to the anterior aspect (p < 0.03). There was a high correlation between burnishing and in vivo duration of the implant (anterior: R = 0.67, p = 0.01, posterior: R = 0.68, p = 0.01). CONCLUSION: The higher concentration of posterior damage on these polyethylene inserts suggested that prosthesis-related (design) or surgeon-related (technique) factors might restrict the articulation of the implant. The resulting higher stresses in the posterior articular surfaces may have contributed to the failure of retrieved implants Keywords: Retrieval, Polyethylene Damage, Total Ankle Replacement.

Haemodynamics of Different Configurations of a Left Subclavian Artery Stent Graft for Thoracic Endovascular Aortic Repair.

OBJECTIVE: Branched stent grafts represent a viable option for left subclavian artery (LSA) revascularisation in patients treated by thoracic endovascular aortic repair (TEVAR) for Zone 2 lesions. This study investigated the haemodynamic performance of different LSA branched stent graft configurations as potential determinants of thrombotic and stroke risks. METHODS: A three dimensional aortic arch geometry extracted from post-operative computed tomography images of a TEVAR patient using a single LSA branched aortic endograft was modified in silico to obtain ten potential LSA branched stent graft configurations: five down facing (0-5 - 10 mm aortic protrusion with 10-12 mm internal diameter), four curved (30-60° with antegrade/retrograde orientation), and one LSA orifice misalignment. The 0 mm down facing stent graft was considered base configuration. Computational fluid dynamic analyses were performed to identify differences in pressure, energy, and wall shear stress (WSS) based parameters. RESULTS: Total pressure drop and energy loss variations among configurations were not greater than 5 mmHg (6% of mean arterial pressure) and 5.7 mW (0.7% of cardiac power), respectively. Protrusions up to 5 mm created clinically insignificant flow disturbances. However, stent graft protrusions further into the aortic lumen created more complex haemodynamics, characterised by larger energy loss and more prominent flow recirculation. Protrusion greater than 5 mm into the lumen was associated with larger areas of elevated maximum WSS (>20 Pa) along the outer surface of the branched stent graft. CONCLUSION: Arterial haemodynamic characteristics are affected by LSA branched stent graft configurations, with pressure drops and energy losses likely to be clinically insignificant. The length of the stent graft protrusion into the aortic lumen generated the largest haemodynamic variations in the aortic system. Protrusions up to 5 mm have smaller risk of potential thrombus generation. Conversely, larger protrusions into the aortic lumen showed more disturbed haemodynamics, suggesting a greater risk of potential thrombus formation, which may be clinically important over time.

Breast Tissue Expander With Radiofrequency Identification Port: Assessment of MRI Issues.

OBJECTIVE. Breast tissue expanders with magnetic ports are MRI unsafe, preventing patients from benefiting from the diagnostic capabilities of MRI. A tissue expander was recently developed with a radiofrequency identification (RFID) port used for needle location and expansion that may be acceptable for a patient undergoing MRI. The purpose of this investigation was to evaluate MRI issues using standardized techniques and well-accepted methods for this tissue expander with RFID port. MATERIALS AND METHODS. The breast tissue expander with RFID port (Motiva Flora Tissue Expander, Establishment Labs) was assessed for magnetic field interactions (translational attraction and torque, 3 T), MRI-related heating (1.5 T/64 MHz and 3 T/128 MHz), artifacts (3 T), and functional changes associated with different MRI conditions (1.5 T/64 MHz and 3 T/128 MHz). RESULTS. Magnetic field interactions were minor (deflection angle of 2° and no torque) and thus will not pose a risk. At 1.5 T/64 MHz and 3 T/128 MHz, the highest temperature elevations (1.7°C and 1.9°C, respectively) were physiologically inconsequential. The tissue expander with RFID port exhibited relatively small artifacts on MRI. Exposures of the tissue expander with RFID port to different MRI conditions did not impact the ability to localize the RFID port or to read the electronic serial number. CONCLUSION. The findings indicated that this tissue expander with RFID port is "MR Conditional" for a patient referred for MRI at 1.5 T or 3 T. Importantly, the relatively small artifact associated with this implant offers potential advantages for patients undergoing MRI compared with tissue expanders that have magnetic ports that create substantial signal losses and distortions on MR images.

Reoperation rates for pelvic organ prolapse repairs with biologic and synthetic grafts in a large population-based cohort.

INTRODUCTION AND HYPOTHESIS: As the long-term complications of synthetic mesh become increasingly apparent, re-evaluation of alternative graft options for pelvic organ prolapse (POP) repairs is critical. We sought to compare the long-term reoperation rates of biologic and synthetic grafts in POP repair. METHODS: Using the California Office of Statewide Health Planning and Development database, we identified all women who underwent index inpatient POP repair with either a synthetic or biologic graft between 2005 and 2011 in the state of California. ICD-9 and CPT codes were used to identify subsequent surgeries in these patients for either recurrent POP or a graft complication. RESULTS: A total of 14,192 women underwent POP repair with a biologic (14%) or synthetic graft (86%) during the study period. Women with biologic grafts had increased rates of surgery for recurrent pelvic organ prolapse (3.6% vs 2.5%, p = 0.01), whereas women with synthetic grafts had higher rates of repeat surgery for a graft complication (3.0 vs 2.0%, p = 0.02). There were no significant differences between the overall risk of repeat surgery between the groups (5.7% vs 5.6%, p = 0.79). These effects persisted in multivariate modeling. CONCLUSIONS: We demonstrate in a large population-based cohort that biologic grafts are associated with an increased rate of repeat surgery for POP recurrence whereas synthetic mesh is associated with an increased rate of repeat surgery for a graft complication. These competing risks result in an equivalent overall any-cause repeat surgery rate between the groups. These data suggest that neither type of graft should be excluded from use and encourage a personalized risk assessment.

Are Lipped Polyethylene Liners Associated with Increased Revision Rates in Patients with Uncemented Acetabular Components? An Observational Cohort Study.

BACKGROUND: Recurrent dislocation after THA remains a serious complication that carries with it a high risk of revision surgery. Previous studies have shown reduced dislocation rates with the use of lipped polyethylene (PE) liners in modular uncemented acetabular components, but there may be increased wear because of impingement, which may lead to aseptic loosening in the longer term; whether the aggregate benefit of lipped PE liners outweighs the risks associated with their use remains controversial. QUESTIONS/PURPOSES: We used data from the New Zealand Joint Registry to (1) compare Kaplan-Meier survival rates, (2) rates of revisions for dislocation between neutral and lipped PE liners, and (3) revision rates for aseptic loosening for the four most commonly used modular uncemented cups. METHODS: We used data from the New Zealand Joint Registry (NZJR) to identify 31,247 primary THAs using the four most commonly used uncemented modular acetabular implants from January 1, 1999 to December 31, 2018. The lipped liner group comprised 49% males (9924 of 20,240) compared with 42% (4669 of 11,007) in the neutral group (p < 0.001); 96% (19,382 of 20,240) of patients in the liner group had OA versus 95% (10,450 of 11,007) in the neutral group (p < 0.001). There was no difference in other patient characteristics such as age (mean 66.9 years), BMI (mean 29 ± 6 kg/m) and American Society of Anesthesiologists grade. The mean follow-up was 5.1 years (SD 3.9) and longest follow-up 19.3 years. The NZJR has more than 96% capture rate and data entry is a mandatory requirement of members of the New Zealand Orthopaedic Association. Kaplan-Meier survival rates were compared between 20,240 lipped and 11,007 neutral PE liners. Highly cross-linked polyethylene was used in 99% of lipped liner cups and 85% of neutral liner cups. Associated hazard ratios were calculated using a Cox regression analysis with a Kaplan-Meier revision-free estimates plot. RESULTS: The Kaplan-Meier survival at 10 years for lipped PE liners was 96% (95% confidence interval 95.4 to 96.2) and for neutral liners 95% (95% CI 94.7 to 95.9). After controlling for age, gender approach, femoral head size, and the use of image guidance, the all-cause revision risk was greater for neutral PE liners than that for lipped PE liners (HR 1.17 [95% CI 1.06 to 1.36]; p = 0.032). There was a higher risk of revision for dislocation in those with neutral PE liners than in those with lipped liners (HR 1.84 [95% CI 1.41 to 2.41]; p < 0.001) but no difference in the revision rate for aseptic acetabular component loosening (HR 0.85 [95% CI 0.52 to 1.38]; p = 0.511). CONCLUSIONS: The use of a lipped PE liner is not associated with a higher rate of aseptic loosening in patients who undergo primary THA compared with a neutral PE liner. Lipped PE liners are associated with lower rates of dislocation and lower all-cause revision rates without any increased association with revision rates for wear and aseptic loosening. LEVEL OF EVIDENCE: Level III, therapeutic study.

Are There Differences in Micromotion on Radiostereometric Analysis Between Bicruciate and Cruciate-retaining Designs in TKA? A Randomized Controlled Trial.

BACKGROUND: Bicruciate-retaining TKA has been proposed to improve clinical outcomes by maintaining intrinsic ACL function. However, because the unique design of the bicruciate-retaining tibial component precludes a tibial stem, fixation may be compromised. A radiostereometric analysis permits an evaluation of early migration of tibial components in this setting, but to our knowledge, no such analysis has been performed. QUESTIONS/PURPOSES: We performed a randomized controlled trial using a radiostereometric analysis and asked, at 2 years: (1) Is there a difference in tibial implant migration between the bicruciate-retaining and cruciate-retaining TKA designs? In a secondary analysis, we asked: (2) Is there a difference in patient-reported outcomes (Oxford Knee Score [OKS] and Forgotten Joint Score [FJS] between the bicruciate-retaining and cruciate-retaining TKA designs? (3) What is the frequency of reoperations and revisions for the bicruciate-retaining and cruciate-retaining TKA designs? METHODS: This parallel-group trial (ClinicalTrials.gov: NCT01966848) randomized 50 patients with an intact ACL who were eligible to undergo TKA to receive either a bicruciate-retaining or cruciate-retaining TKA. Patients were blinded to treatment allocation. The primary outcome was the maximum total point motion (MTPM) of the tibial component measured with model-based radiostereometric analysis (RSA) at 2 years postoperatively. The MTPM is a translation vector defined as the point in the RSA model that has the greatest combined translation in x-, y- and z-directions. A 1-year postoperative mean MTPM value of 1.6 mm has been suggested as a threshold for unacceptable increased risk of aseptic loosening after both 5 and 10 years. The repeatability of the MTPM was found to be 0.26 mm in our study. Patient-reported outcome measures were assessed preoperatively and at 2 years postoperatively with the OKS (scale of 0-48, worst-best) and FJS (scale of 0-100, worst-best). Baseline characteristics did not differ between groups. At 2 years postoperatively, RSA images were available for 22 patients who underwent bicruciate-retaining and 23 patients who underwent cruciate-retaining TKA, while patient-reported outcome measures were available for 24 patients in each group. The study was powered to detect a 0.2-mm difference in MTPM between groups (SD = 0.2, significance level = 5%, power = 80%). RESULTS: With the numbers available, we found no difference in MTPM between the bicruciate-retaining and cruciate-retaining groups. The median (interquartile range [IQR]) MTPM was 0.52 mm (0.35 to 1.02) and 0.42 mm (0.34 to 0.70) in the bicruciate-retaining and cruciate-retaining groups, respectively (p = 0.63). There was no difference in the magnitude of improvement in the OKS from preoperatively to 2 years postoperative between the groups (median delta [IQR] for bicruciate-retaining 18 [14 to 23] versus cruciate-retaining 18 [15 to 21], difference of medians 0; p = 0.96). Likewise, there was no difference in the magnitude of improvement in the FJS score from preoperatively to 2 years postoperative between the groups (mean ± SD for bicruciate-retaining 46 ± 32 versus cruciate-retaining 48 ± 16, mean difference, 2; p = 0.80). Three patients in the bicruciate-retaining group underwent arthroscopically assisted manipulation at 3 to 4 months postoperatively, and one patient in the bicruciate-retaining group sustained a tibial island fracture during primary surgery and underwent a revision procedure after 6 months. There were no reoperations or revisions in the cruciate-retaining group. CONCLUSIONS: With the numbers available, we found no differences between the bicruciate-retaining and the cruciate-retaining implants in terms of stable fixation on RSA or patient-reported outcome measure scores at 2 years, and must therefore recommend against the routine clinical use of the bicruciate-retaining device. The complications we observed with the bicruciate-retaining device suggest it has an associated learning curve and the associated risks of novelty with no demonstrable benefit to the patient; it is also likely to be more expensive in most centers. Continued research on this implant should only be performed in the context of controlled trials. LEVEL OF EVIDENCE: Level II, therapeutic study.

Early bioprosthetic tricuspid valve stenosis due to size mismatch in Ebstein anomaly-Successful transcatheter treatment.

Patients with congenital heart disease are surviving well into adulthood thanks to advances in medical and clinical care. We present a patient with Ebstein anomaly who underwent surgical tricuspid valve replacement and suffered early valve stenosis due to her unique anatomy. This case highlights the importance of the "unnatural" anatomy that can be encounter in this challenging patient population.

Sleep improvement after hip arthroplasty: a study on short-stem prosthesis.

PURPOSE: The purpose of this study was to evaluate sleep disturbance prospectively before and after short-stem hip arthroplasty. METHODS: A prospective study on 25 patients undergoing a primary unilateral total short-stem hip replacement was conducted. Patients were observed for six months. To evaluate the sleep quality and daytime sleepiness, the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale were used. To assess the general physical health status, we used the Short Form 36 Health Survey (SF-36). Pain was recorded on a visual analog scale. RESULTS: The physical health status of the patients improved significantly (p < 0.05) during the six month follow-up period in seven out of nine categories. During the first post-operative week, the sleep quality stayed on an equal level to the pre-operative state, following a steady improvement over the next months (6 months p = 0.00). The daytime sleepiness showed a significant improvement during all the follow-ups (6 months p = 0.00). Pain decreased significantly from baseline to six months post-operatively (p = 0.00). There was no correlation between pain and sleep quality or pain and daytime sleepiness. CONCLUSION: According to our results, patients undergoing short-stem total hip arthroplasty can expect a 50% improvement of sleep quality and physical function six months after surgery.

Incidence and pattern of periprosthetic hip fractures around the stem in different stem geometry.

BACKGROUND: The number of total hip arthroplasties (THA) is expected to increase worldwide; thus, complications are likely to increase at the same ratio. In this scenario, periprosthetic femoral fractures (PFFs) are an increasing concern. Identifying the predisposing factors is important in order to prevent as much as possible the risk of PFF in the future. PATIENTS AND METHODS: The purpose of this study was to correlate the risk of periprosthetic femoral fractures to the most common patients' comorbidities and stem geometry. We reviewed all THA for non-oncologic indications between 2004 and 2014 with a mean follow-up of six years (range, 2-12). Three thousand two hundred forty-eight patients (3593 implants) were enrolled in the study, and 45 PFF were registered during this time period. Two thousand five hundred seventy-seven implants (71%) were straight stems, and 1015 (28.3%) were anatomic stems. All X-rays were then analyzed and classified according to the modified Vancouver classification. RESULTS: Periprosthetic femoral fractures incidence was associated with anatomic stem geometry (p < 0.001, OR = 2.2), BMI (p < 0.001), and diabetes (p < 0.001, OR = 5.18). PFFs were not significantly associated with age, gender, and all the other variables. Fracture pattern was different between straight and anatomic stems. Clamshell fractures were more likely to occur in anatomic stems compared to straight stems (p < 0.005). CONCLUSIONS: Periprosthetic femoral fractures are highly associated with obesity and osteoporosis. Anatomic stems reported a higher incidence of PPF than straight stems. The typical fracture type for anatomical stems is the clamshell pattern, while straight stems are more likely affected by type B fractures.

Migration of the uncemented Echo Bi-Metric and Bi-Metric THA stems: a randomized controlled RSA study involving 62 patients with 24-month follow-up.

Background and purpose - Despite the good results after total hip arthroplasty (THA), new implants are continuously being developed to improve durability. The Echo Bi-Metric (EBM) THA stem is the successor to the Bi-Metric (BM) THA stem. The EBM stem includes many of the features of the BM stem, but minor changes in the design might improve the clinical performance. We compared the migration behavior with radiostereometric analysis (RSA) of the EBM stem and the BM stem at 24 months and evaluated the clinical outcome. Patients and methods - We randomized 62 patients with osteoarthritis (mean age 64 years, female/male 28/34) scheduled for an uncemented THA to receive either an EBM or a BM THA stem. We performed RSA within 1 week after surgery and at 3, 6, 12, and 24 months. The clinical outcome was evaluated using Harris Hip Score (HHS) and Oxford Hip Score (OHS). Results - At 24 months, we found no statistically significant differences in migration between the two implants. During the first 3 months both the EBM and the BM stems showed visible subsidence (2.5 mm and 2.2 mm respectively), and retroversion (2.5° and 2.2° respectively), but after 3 months this stabilized. The expected increase in HHS and OHS was similar between the groups. Interpretation - The EBM stem showed a migration at 24 months not different from the BM stem, and both stems display satisfying clinical results.

Does cup position differ between trabecular metal and titanium cups? A radiographic propensity score matched study of 300 hips.

Background and purpose - The use of trabecular metal cups in primary total hip arthroplasty (THA) is increasing, despite the survival of Continuum cups being slightly inferior compared with other uncemented cups in registries. This difference is mainly explained by a higher rate of dislocation revisions. Cup malpositioning is a risk factor for dislocation and, being made of a highly porous material, Continuum cups might be more difficult to position. We evaluated whether Continuum cups had worse cup positioning compared with other uncemented cups. Patients and methods - Based on power calculation, 150 Continuum cups from 1 center were propensity score matched with 150 other uncemented cups from 4 centers. All patients had an uncemented stem, femoral head size of 32 mm or 36 mm, and BMI between 19 and 35. All operations were done for primary osteoarthrosis through a posterior approach. Patients were matched using age, sex, and BMI. Cup positioning was measured from anteroposterior pelvic radiograph using the Martell Hip Analysis Suite software. Results - There was no clinically relevant difference in mean inclination angle between the study group and the control group (43° [95% CI 41-44] and 43° [CI 42-45], respectively). The study group had a larger mean anteversion angle compared with the control group, 19° (CI 18-20) and 17° (CI 15-18) respectively. Interpretation - Continuum cups had a greater anteversion compared with the other uncemented cups. However, the median anteversion was acceptable in both groups and this difference does not explain the larger dislocation rate in the Continuum cups observed in earlier studies.

Long-term migration of a cementless stem with different bioactive coatings. Data from a "prime" RSA study: lessons learned.

Background and purpose - Little is known about the long-term migration pattern of cementless stems in total hip arthroplasty (THA). Furthermore, the role of bioactive coatings in fixation, and thus migration, remains uncertain. Hydroxyapatite (HA) is the most commonly used bioactive coating. However, delamination of the coating might induce loosening. Alternatively, fluorapatite (FA) has proved to be more thermostable than HA, thereby potentially increasing longevity. We assessed the long-term migration of cementless stems with different coatings using radiostereometric analysis (RSA), thereby establishing a reference for acceptable migration. Patients and methods - 61 THAs in 53 patients were randomized to receive either a HA, FA, or uncoated Mallory-Head Porous stem during the years 1992 to 1994. Primary outcome was stem migration measured using RSA and secondary outcome was the Harris Hip Score (HHS). Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 25 and 52 weeks, and annually thereafter. At the 25-year follow-up, 12 patients (17 THAs) had died and 1 patient (1 THA) was lost to follow-up. Due to the high number of missing second-day postoperative RSA radiographs, the 1-year postoperative RSA radiograph was used as baseline for the comparative analyses. Results - Mean follow-up was 17 years (SD 6.6). All stems showed initial rapid migration with median subsidence of 0.2 mm (-0.1 to 0.6) and median retroversion of 0.9° (-3.2 to 2) at 12 months, followed by stable migration reaching a plateau phase. No stem was revised, albeit 1 stem showed continuous subsidence up to 1.5 mm. Comparing the different coatings, we could not find a statistically significant difference in overall 25-year migration (p-values > 0.05). Median subsidence at 15-year follow-up was for HA -0.1 mm (-0.4 to 0.2), for FA 0 mm (-0.1 to 0.2), and for uncoated stems 0.2 mm (-0.1 to 0.5). Median internal rotation at 15-year follow-up was for HA not available, for FA 1.1° (-0.5 to 2.6), and for uncoated stems 0° (-0.5 to 0.4). HHS were also comparable (p-values > 0.05), with at 15-year follow-up for HA 85 points (41-99), for FA 76 points (61-90), and for uncoated stems 79 points (74-90). Interpretation - The long-term migration pattern of cementless stems using different bioactive coatings has not previously been described. No beneficial effect, or side effect at long-term follow-up of bioactive coatings, was found. The provided migration data can be used in future research to establish thresholds for acceptable migration patterns cementless stem designs.

A vitamin E blended highly cross-linked polyethylene acetabular cup results in less wear: 6-year results of a randomized controlled trial in 199 patients.

Background and purpose - Survivorship of total hip arthroplasty (THA) with the ultra-high molecular weight polyethylene (UHMWPE) monoblock cup has been limited due to periprosthetic osteolysis and aseptic loosening, secondary to wear of the UHMWPE. In response, a vitamin E blended highly cross-linked polyethylene (HXLPE) cup was developed. This study set out to compare the wear and clinical 6-year outcomes of vitamin E blended HXLPE with UHMWPE in an isoelastic monoblock cup in patients with hip osteoarthritis who underwent uncemented THA. The 2-year results have been reported previously. Patients and methods - For this randomized controlled trial 199 patients were included. 102 patients received the vitamin E blended HXLPE uncemented acetabular cup and 97 patients the uncemented UHMWPE monoblock cup. Clinical and radiographic parameters were obtained preoperatively, directly postoperatively, and at 3, 12, 24, and 72 months. Wear rates were compared using the femoral head penetration (FHP) rate. Results - 173 patients (87%) completed the 6-year follow-up. The mean NRS scores for rest pain, load pain, and patient satisfaction were 0.3 (SD 1), 0.6 (SD 1), and 8.6 (SD 1) respectively. The mean Harris Hip Score was 93 (SD 12). The FHP rate was lower in the vitamin E blended HXLPE cup (0.028 mm/year) compared with the UHMWPE cup (0.035 mm/year) (p = 0.002). No adverse reactions associated with the clinical application of vitamin E blended HXLPE were observed. 15 complications occurred, equally distributed between the two cups. The 6-year survival to revision rate was 98% for both cups. There was no aseptic loosening. Interpretation - This study shows the superior performance of the HXLPE blended with vitamin E acetabular cup with clinical and radiographic results similar to the UHMWPE acetabular cup.