Do Fixed or Mobile Bearing Implants Have Better Survivorship in Medial Unicompartmental Knee Arthroplasty? A Study From the Australian Orthopaedic Association National Joint Replacement Registry.

BACKGROUND: During the last 5 years, there has been an increase in the use of unicompartmental knee arthroplasty (UKA) to treat knee osteoarthritis in Australia, and these account for almost 6% of annual knee replacement procedures. However, there is debate as to whether a fixed bearing or a mobile bearing design is best for decreasing revision for loosening and disease progression as well as improving survivorship. Small sample sizes and possible confounding in the studies on the topic may have masked differences between fixed and mobile bearing designs. QUESTIONS/PURPOSES: Using data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), we selected the four contemporary designs of medial compartment UKA: mobile bearing, fixed modular, all-polyethylene, and fixed molded metal-backed used for the treatment of osteoarthritis to ask: (1) How do the different designs of unicompartmental knees compare with survivorship as measured by cumulative percentage revision (CPR)? (2) Is there a difference in the revision rate between designs as a function of patient sex or age? (3) Do the reasons for revision differ, and what types of revision procedures are performed when these UKA are revised? METHODS: The AOANJRR longitudinally maintains data on all primary and revision joint arthroplasties, with nearly 100% capture. The study population included all UKA procedures undertaken for osteoarthritis between September 1999 and December 2018. Of 56,628 unicompartmental knees recorded during the study period, 50,380 medial UKA procedures undertaken for osteoarthritis were included in the analysis after exclusion of procedures with unknown bearing types (31 of 56,628), lateral or patellofemoral compartment UKA procedures (5657 of 56,628), and those performed for a primary diagnosis other than osteoarthritis (560 of 56,628). There were 50,380 UKA procedures available for analysis. The study group consisted of 40% (20,208 of 50,380) mobile bearing UKA, 35% (17,822 of 50,380) fixed modular UKA, 23% (11,461 of 50,380) all-polyethylene UKA, and 2% (889 of 50,380) fixed molded metal-backed UKA. There were similar sex proportions and age distributions for each bearing group. The overall mean age of patients was 65 ± 9.4 years, and 55% (27,496 of 50,380) of patients were males. The outcome measure was the CPR, which was defined using Kaplan-Meier estimates of survivorship to describe the time to the first revision. Hazard ratios from Cox proportional hazards models, adjusted for sex and age, were performed to compare the revision rates among groups. The cohort was stratified into age groups of younger than 65 years and 65 years and older to compare revision rates as a function of age. Differences among bearing groups for the major causes and modes of revision were assessed using hazard ratios. RESULTS: At 15 years, fixed modular UKA had a CPR of 16% (95% CI 15% to 17%). In comparison, the CPR was 23% (95% CI 22% to 24%) for mobile bearing UKA, 26% (95% CI 24% to 27%) for all-polyethylene UKA, and 20% (95% CI 16% to 24%) for fixed molded metal-backed UKA. The lower revision rate for fixed modular UKA was seen through the entire period compared with mobile bearing UKA (hazard ratio 1.5 [95% CI 1.4 to 1.6]; p < 0.001) and fixed molded metal-backed UKA (HR 1.3 [95% CI 1.1 to 1.6]; p = 0.003), but it varied with time compared with all-polyethylene UKA. The findings were consistent when stratified by sex or age. Although all-polyethylene UKA had the highest revision rate overall and for patients younger than 65 years, for patients aged 65 years and older, there was no difference between all-polyethylene and mobile bearing UKA. When compared with fixed modular UKA, a higher revision risk for loosening was shown in both mobile bearing UKA (HR 1.7 [95% CI 1.5 to 1.9]; p < 0.001) and all-polyethylene UKA (HR 2.4 [95% CI 2.1 to 2.7]; p < 0.001). The revision risk for disease progression was higher for all-polyethylene UKA at all time points (HR 1.4 [95% CI 1.3 to 1.6]; p < 0.001) and for mobile bearing UKA after 8 years when each were compared with fixed modular UKA (8 to 12 years: HR 1.4 [95% CI 1.2 to 1.7]; p < 0.001; 12 or more years: HR 1.9 [95% CI 1.5 to 2.3]; p < 0.001). The risk of revision to TKA was higher for mobile bearing UKA compared with fixed modular UKA (HR 1.4 [95% CI 1.3 to 1.5]; p < 0.001). CONCLUSION: If UKA is to be considered for the treatment of isolated medial compartment osteoarthritis, the fixed modular UKA bearing has the best survivorship of the current UKA designs. LEVEL OF EVIDENCE: Level III, therapeutic study.

Low revision rate of dual mobility cups after arthroplasty for acute hip fractures: report of 11,857 hip fractures in the Dutch Arthroplasty Register (2007-2019).

Background and purpose - Dislocation is one of the most frequent reasons for cup revision after total hip arthroplasty (THA) for an acute fracture. A dual mobility cup (DMC) might reduce this risk. We determined the cup revision rate after THA for an acute fracture according to type of cup.Patients and methods - All THAs for an acute fracture registered in the Dutch Arthroplasty Register (LROI) during 2007-2019 were included (n = 11,857). Type of cup was divided into DMC and unipolar cup (UC). Competing risk analyses were performed with cup revision for any reason as endpoint. Multivariable Cox regression analyses with outcome cup revision were performed adjusted for sex, age, ASA class, and surgical approach, stratified for UC THA with femoral head size of 32 mm and 22-28 mm.Results - A DMC was used in 1,122 (9%) hips. The overall 5-year cup revision rate for any reason after THA for acute fracture was 1.9% (95% CI 1.6-2.2). Cup revision for dislocation within 5 years was performed in 1 of 6 DMC THAs versus 108 of 185 (58%) UC THAs. Univariable Cox regression analyses showed no statistically significant difference in cup revision rate between DMC and UC (HR = 0.8; CI 0.4-1.5). Multivariable Cox regression analyses showed lower risk of cup revision in DMC THA (n = 1,122) compared with UC THA with 22-28 mm femoral head size (n = 2,727) (HR = 0.4; CI 0.2-0.8).Interpretation - The 5-year cup cumulative incidence of revision after THA for acute fracture was comparable for DMC and UC THA. However, DMC THA had a lower risk of cup revision than UC THA with 22-28 mm femoral head.

No difference in patient preference for medial pivot versus posterior-stabilized design in staged bilateral total knee arthroplasty: a prospective study.

PURPOSE: Medial pivot (MP) TKA has been shown to mimic normal knee kinematics with long-term survivorship comparable to most contemporary TKA. However, there are inadequate evidences to suggest its superiority in terms of patient preference and satisfaction. The aim of this study is to compare the MP with posterior-stabilized (PS) TKA in terms of patient preference and satisfaction. METHODS: 46 patients with staged bilateral TKA were recruited. TKA with MP or PS design was performed at interval of 6-12 months. Patient preference, patient satisfaction score (0-100), Forgotten Joint Score (FJS), range of motion (ROM), Pain Score, Knee Society Score (KSS), Knee Function Score (KFS) and WOMAC Score were compared at up to 12 months. RESULTS: The mean age was 70 and 69.6% were female. There was no difference in all preoperative parameters, operative time and length of stay between two knees. No difference was found in in range of motion and all outcome scores at 6 months and 12 months. Satisfaction score was similar for the two designs (82 vs 85, p = n.s.) at 1 year after the second TKA. Proportion of patients with preference on one design over another was not significantly different (28.9 vs 35.6%, p = n.s.). CONCLUSIONS: There is no evidence to support the superiority of MP TKA over PS TKA in terms of preference and satisfaction. The choice between MP TKA versus PS TKA maybe more a surgeon's preference than a patient's preference based on current evidence.

Prediction of wear performance in femoral and tibial conformity in patient-specific cruciate-retaining total knee arthroplasty.

BACKGROUND: Articular surface curvature design is important in tibiofemoral kinematics and the contact mechanics of total knee arthroplasty (TKA). Thus far, the effects of articular surface curvature have not been adequately discussed with respect to conforming, nonconforming, and medial pivot designs in patient-specific TKA. Therefore, this study evaluates the underlying relationship between the articular surface curvature geometry and the wear performance in patient-specific TKA. METHODS: We compare the wear performances between conventional and patient-specific TKA under gait loading conditions using a computational simulation. Patient-specific TKAs investigated in the study are categorized into patient-specific TKA with conforming articular surfaces, medial pivot patient-specific TKA, and bio-mimetic patient-specific TKA with a patient's own tibial and femoral anatomy. The geometries of the femoral components in patient-specific TKAs are identical. RESULTS: The anterior-posterior and internal-external kinematics change with respect to different TKA designs. Moreover, the contact pressure and area did not directly affect the wear performance. In particular, conforming patient-specific TKAs exhibit the highest volumetric wear and wear rate. The volumetric wear in a conforming patient-specific TKA is 29% greater than that in a medial pivot patient-specific TKA. CONCLUSION: The findings in this study highlight that conformity changes in the femoral and tibial inserts influence the wear performance in patient-specific TKA. Kinematics and contact parameters should be considered to improve wear performance in patient-specific TKA. The conformity modification in the tibiofemoral joint changes the kinematics and contact parameters, and this affects wear performance.

Comparison of posterior-stabilized, cruciate-retaining, and medial-stabilized knee implant motion during gait.

Accurate knowledge of knee joint motion is needed to evaluate the effects of implant design on functional performance and component wear. We conducted a randomized controlled trial to measure and compare 6-degree-of-freedom (6-DOF) kinematics and femoral condylar motion of posterior-stabilized (PS), cruciate-retaining (CR), and medial-stabilized (MS) knee implant designs for one cycle of walking. A mobile biplane X-ray imaging system was used to accurately measure 6-DOF tibiofemoral motion as patients implanted with PS (n = 23), CR (n = 25), or MS (n = 26) knees walked over ground at their self-selected speeds. Knee flexion angle did not differ significantly between the three designs. Relative movements of the femoral and tibial components were generally similar for PS and CR with significant differences observed only for anterior tibial drawer. Knee kinematic profiles measured for MS were appreciably different: external rotation and abduction of the tibia were increased while peak-to-peak anterior drawer was significantly reduced for MS compared with PS and CR. Anterior-posterior drawer and medial-lateral shift of the tibia were strongly coupled to internal-external rotation for MS, as was anterior-posterior translation of the contact center in the lateral compartment. MS exhibited the least amount of paradoxical anterior translation of the femur relative to the tibia during knee flexion. The joint center of rotation in the transverse plane was located in the lateral compartment for PS and CR and in the medial compartment for MS. Substantial differences were evident in 6-DOF knee kinematics between the healthy knee and all three prosthetic designs. Overall, knee kinematic profiles observed for MS resemble those of the healthy joint more closely than PS and CR.

Polyethylene manufacturing characteristics have a major effect on the risk of revision surgery in cementless and hybrid total hip arthroplasties.

AIMS: The aim of this study was to identify the effect of the manufacturing characteristics of polyethylene acetabular liners on the survival of cementless and hybrid total hip arthroplasty (THA). METHODS: Prospective cohort study using linked National Joint Registry (NJR) and manufacturer data. The primary endpoint was revision for aseptic loosening. Cox proportional hazard regression was the primary analytical approach. Manufacturing variables included resin type, crosslinking radiation dose, terminal sterilization method, terminal sterilization radiation dose, stabilization treatment, total radiation dose, packaging, and face asymmetry. Total radiation dose was further divided into G1 (no radiation), G2 (> 0 Mrad to < 5 Mrad), G3 (≥ 5 Mrad to < 10 Mrad), and G4 (≥ 10 Mrad). RESULTS: A total of 5,329 THAs were revised, 1,290 of which were due to aseptic loosening. Total radiation dose, face asymmetry, and stabilization treatments were found to significantly affect implant survival. G1 had the highest revision risk for any reason and for aseptic loosening and G3 and G4 the lowest. Compared with G1, the adjusted hazard ratio for G2 was 0.74 (95% confidence interval (CI) 0.64 to 0.86), G3 was 0.36 (95% CI 0.30 to 0.43), and G4 was 0.38 (95% CI 0.31 to 0.47). The cumulative incidence of revision for aseptic loosening at 12 years was 0.52 and 0.54 per 100 THAs for G3 and G4, respectively, compared with 1.95 per 100 THAs in G1. Asymmetrical liners had a lower revision risk due to aseptic loosening and reasons other than aseptic loosening compared with symmetric (flat) liners. In G3 and G4, stabilization with vitamin E and heating above melting point performed best. CONCLUSION: Polyethylene liners with a total radiation dose of ≥ 5 Mrad, an asymmetrical liner face, and stabilization with heating above the melting point demonstrate best survival. Cite this article: Bone Joint J 2020;102-B(1):90-101.

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.

Revision Risk for Total Knee Arthroplasty Converted from Medial Unicompartmental Knee Arthroplasty: Comparison with Primary and Revision Arthroplasties, Based on Mid-Term Results from the Danish Knee Arthroplasty Registry.

BACKGROUND: Medial unicompartmental knee arthroplasties (UKAs) have good clinical outcomes but implant survival is inferior to that of total knee arthroplasties (TKAs). Conversion to a TKA is a reliable option when UKA fails. However, there is controversy regarding these conversions. The aim of this study was to analyze the survival of TKAs converted from UKAs when compared with both primary and revision TKAs. METHODS: On the basis of registrations in the Danish Knee Arthroplasty Registry from 1997 to 2017, 1,012 TKAs converted from UKAs were compared with 73,819 primary TKAs and 2,572 revision TKAs. The primary outcome was the risk of revision. Secondarily, the study analyzed the influence of different implants, the indication for the UKA conversion, and surgical volume on the survival of TKA converted from UKA. Third, the study compared the indications for revision. RESULTS: The converted UKAs were mainly mobile-bearing (85%) and, at the time of conversion, the patients were younger (mean [standard deviation], 66 ± 10 years) and more were Charnley class A (55%) compared with patients with primary TKA (70 ± 9 years and 35% class A) or revision TKA (70 ± 10 years and 42% class A) (all p < 0.001). The survival of TKAs converted from UKAs was comparable with that of revision TKAs (p = 0.42) and significantly inferior to the survival of primary TKAs (p < 0.001). This relationship was unaffected by differences between the groups, with an adjusted hazard ratio of 0.94 (95% confidence interval [CI]: 0.74 to 1.19) compared with revision TKAs and 3.00 (95% CI: 2.47 to 3.66) compared with primary TKAs. The survival of TKA converted from UKA was unaffected by differences in the conversion implants (all p ≥ 0.47), experience with revision surgery (all p ≥ 0.06), and the indications for the UKA-to-TKA conversion (all p ≥ 0.27). Instability (26%) and unexplained pain (13%) were more frequent indications for revisions of TKA converted from UKA (p < 0.001). CONCLUSIONS: TKA converted from medial UKA has a 3-fold higher risk of revision when compared with primary TKA. The implant survival resembled that of revision TKA but with a higher prevalence of unexplained pain and instability. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Finite Element- and Design of Experiment-Derived Optimization of Screw Configurations and a Locking Plate for Internal Fixation System.

OBJECTIVES: The optimization for the screw configurations and bone plate parameters was studied to improve the biomechanical performances such as reliable internal fixation and beneficial callus growth for the clinical treatment of femoral shaft fracture. METHODS: The finite element analysis (FEA) of internal fixation system under different screw configurations based on the orthogonal design was performed and so was for the different structural parameters of the locking plate based on the combination of uniform and orthogonal design. Moreover, orthogonal experiment weight matrixes for four evaluation indexes with FEA were analyzed. RESULTS: The analytical results showed the optimal scheme of screw configuration was that screws are omitted in the thread holes near the fracture site, and single cortical screws are used in the following holes to the distal end, while the double cortical screws are fixed in thread holes that are distal to the fracture; in the other words, the length of the screws showed an increasing trend from the fracture site to the distal end in the optimized configuration. The plate structure was optimized when thread holes gap reached 13 mm, with a width of 11 mm and 4.6 mm and 5 mm for thickness and diameter of the screw, respectively. The biomechanical performance of the internal fixation construct was further improved by about 10% based on the optimal strain range and lower stress in the internal fixation system. CONCLUSIONS: The proposed orthogonal design and uniform design can be used in a more efficient way for the optimization of internal fixation system, which can reduce the simulation runs to about 10% compared with comprehensive test, and the methodology can be also used for other types of fractures to achieve better internal fixation stability and optimal healing efficiency, which may provide a method for an orthopedist in choosing the screw configurations and parameters for internal fixation system in a more efficient way.

Comparison of Fixed-Bearing and Mobile-Bearing Unicompartmental Knee Arthroplasty: A Systematic Review and Meta-Analysis.

BACKGROUND: Prior studies have compared fixed-bearing unicompartmental knee arthroplasty (FB-UKA) with mobile-bearing UKA (MB-UKA), suggesting that both procedures have good clinical outcomes. However, which treatment is more beneficial for patients is controversial. The purpose of our study is to evaluate the postoperative outcomes, including the revision rate, complications, functional results, range of motion, and femoral-tibial angle, between the 2 procedures. METHODS: We searched the MEDLINE, EMBASE, Cochrane Library, and Web of Science databases starting from August 2017 to May 2018. The publication date of articles was not restricted. Before we submit our contribution, we have re-searched it again. Articles that directly compared the postoperative outcomes of the 2 prosthesis type were included. RESULTS: A total of 15 comparative studies were included in our meta-analysis. The pooled data indicated no differences between the 2 operation modes in terms of revision rates, complications, and knee function, but earlier failure occurred more frequently with the MB design. CONCLUSION: Both the arthroplasty types provided satisfactory clinical results for patients with classic indications. However, MB-UKA tended to fail in early postoperative years whereas fixed-bearing UKA in later postoperative years. Therefore treatment options should be carefully considered for each patient, and surgeons should still use their personal experience when deciding between these options.

Prevalence of Postoperative Periprosthetic Femur Fractures Between Two Different Femoral Component Designs Used in Direct Anterior Total Hip Arthroplasty.

BACKGROUND: Periprosthetic femur fractures are a well-documented complication following direct anterior uncemented total hip arthroplasty. The purpose of this study is to compare the prevalence of postoperative periprosthetic femur fractures between 2 different femoral component designs used in direct anterior total hip arthroplasty. METHODS: Beginning in February 2015, a single fellowship-trained adult reconstruction surgeon performed 361 consecutive direct anterior total hip replacements using a flat, single-taper, wedged femoral implant. In June 2016, that same surgeon, using the exact same surgical technique and postoperative weight-bearing protocol, began using a dual-taper, hydroxyapatite-coated implant for 789 consecutive hips. The patients were carefully monitored for 3 months after surgery to identify the frequency of periprosthetic femur fractures. A Fisher's exact test was used to determine if the prevalence of periprosthetic femur fractures differed between the 2 implant designs. RESULTS: Five of 361 (1.4%) patients sustained proximal femur fractures at an average of 19.6 days postoperatively in the first group, all demonstrating a Vancouver type B2 periprosthetic fracture and requiring femoral revision. No patients (0/789, 0%) in the second cohort sustained a postoperative, periprosthetic fracture (P = .006). CONCLUSION: In this comparison of 2 consecutive cohorts, the dual-taper, hydroxyapatite-coated implant had a statistically significant lower postoperative periprosthetic fracture rate than a flat, single-taper, wedged design.

Evaluación multicéntrica del sobredimensionamiento de la prótesis transcatéter SAPIEN 3. Impacto en el fallo del dispositivo y nuevos implantes de marcapasos / Multicenter evaluation of prosthesis oversizing of the SAPIEN 3 transcatheter heart valve. Impact on device failure and new pacemaker implantations

Introducción y objetivos: Para lograr el éxito del dispositivo, se recomienda cierto sobredimensionamiento de la prótesis (SP) SAPIEN 3. Sin embargo, un aumento en el SP puede incrementar las tasas de implante de marcapasos definitivo (IMD). Por lo tanto, se investiga la influencia del SP en el fallo del dispositivo y el IMD. Métodos: Se trató con SAPIEN 3 a 804 pacientes en 3 centros. El SP, determinado mediante tomografía computarizada multicorte, se calculó y analizó como variable continua y categorizada en incrementos del 5%, con -4% a 0 como referencia. Resultados: Se produjo fallo del dispositivo en el 8,8% de los pacientes. La mediana de SP fue menor en los pacientes con fallo del dispositivo que en aquellos con éxito (el +4 frente al +8%; p=0,038). El SP mostró un patrón de riesgo no lineal, con una tasa de fallo del dispositivo significativamente reducida para valores entre el +4 y el +22%. No hubo ningún caso de fuga paravalvular II+ entre un +10 y un +20% de SP. La tasa general de IMD fue del 16,2% y la mediana de SP fue significativamente mayor en los pacientes con IMD (IMD, el +9% frente a no IMD, el +7%; p=0,025), mientras que la profundidad del implante no varió entre pacientes con y sin IMD (6,9+/-1,7 frente a 6,6+/-1,9mm; p=0,101). El riesgo de IMD aumentó con el aumento del SP y fue mayor en las 2 categorías más altas. Conclusiones: El incremento en el SP reduce el riesgo de fallo del dispositivo, pero aumenta el de IMD. No se halló un intervalo de SP ideal para minimizar los riesgos de fallo del dispositivo e IMD

Introduction and objectives: A certain degree of prosthesis oversizing (OS) is recommended for the SAPIEN 3 to achieve device success. However, an increase in OS may increase permanent pacemaker implantation (PPI) rates. We therefore investigated the influence of OS on device failure and PPI. Methods: A total of 804 patients were treated with SAPIEN 3 at 3 centers. Multislice computed tomography-derived OS was calculated and analyzed both as a continuous variable and categorized in 5% increments with −4% to 0% as reference. Results: Device failure occurred in 8.8% of patients. Median OS was lower in patients with device failure vs those with device success (+4% vs +8%; P=.038). A nonlinear risk pattern was shown for OS with a significantly reduced device failure rate within 4% to +22% of OS. There was no case of paravalvular leakage II+ between +10% to +20% of OS. The overall PPI rate was 16.2% and the median OS was significantly larger in patients with PPI (PPI: +9% vs no PPI: +7%; P = .025), while implantation depth did not vary in patients with vs without PPI (6.9+/-1.7 mm vs 6.6+/-1.9 mm; P=.101). The risk of PPI increased with increasing OS and was highest in the 2 highest categories. Conclusions: An increase in OS reduces the risk for device failure but increases the risk for PPI. There was no ideal range of OS to minimize both device failure and PPI

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. METHODS: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. RESULTS: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. CONCLUSIONS: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.

Implementation of 3D Printing Technology in the Field of Prosthetics: Past, Present, and Future.

There is an interesting and long history of prostheses designed for those with upper-limb difference, and yet issues still persist that have not yet been solved. Prosthesis needs for children are particularly complex, due in part to their growth rates. Access to a device can have a significant impact on a child's psychosocial development. Often, devices supporting both cosmetic form and user function are not accessible to children due to high costs, insurance policies, medical availability, and their perceived durability and complexity of control. These challenges have encouraged a grassroots effort globally to offer a viable solution for the millions of people living with limb difference around the world. The innovative application of 3D printing for customizable and user-specific hardware has led to open-source Do It Yourself "DIY" production of assistive devices, having an incredible impact globally for families with little recourse. This paper examines new research and development of prostheses by the maker community and nonprofit organizations, as well as a novel case study exploring the development of technology and the training methods available. These design efforts are discussed further in the context of the medical regulatory framework in the United States and highlight new associated clinical studies designed to measure the quality of life impact of such devices.

Nonmodular Stems Are a Viable Alternative to Modular Stems in Revision Total Hip Arthroplasty.

BACKGROUND: Nonmodular and modular femoral stems have been associated with complications after revision total hip arthroplasty (rTHA). As such, the ideal femoral component for rTHA remains undecided. This study aims to report outcomes of titanium, tapered-fluted, modular and nonmodular femoral components in rTHA. METHODS: From January 1, 2013 to September 30, 2017, all rTHAs using modular or nonmodular femoral stems were identified. Demographic data including age, gender, and American Society of Anesthesiologists scores were collected. Surgical details including operative time and implant cost were also collected. Clinical outcomes including length of stay, dislocation, infection, fracture, reoperation, and re-revision were collected. Statistical analysis was performed using chi-square test and Student's t-test for all categorical and continuous variables, respectively. RESULTS: One hundred forty-six rTHA cases (103 modular and 43 nonmodular) were identified with an average follow-up of 29 months (range 3-59 months). Nonmodular stems had a significantly lower cost when compared to modular implants (modular stems 120.8% higher cost; P < .001). The surgical time of nonmodular components was significantly greater (193 minutes vs 163 minutes; P = .029). There were no differences observed in any other surgical details or clinical outcomes assessed, including length of stay (P = .323), rate of re-revision of the femoral implant (P = .389), rate of re-operation (P = .383), and postop complications (P = .241), including infection (P = .095), dislocation (P = .778), and fracture (P = .959). CONCLUSIONS: Nonmodular components provide encouraging clinical results with significantly lower costs compared to modular implants in rTHA. The use of titanium, tapered-fluted, nonmodular components may offer a more cost-effective approach to rTHA compared to their modular counterparts.

Multicenter Evaluation of a Modular Dual Mobility Construct for Revision Total Hip Arthroplasty.

INTRODUCTION: Modular Dual Mobility (MDM) constructs in total hip arthroplasty (THA) offer increased hip stability compared with constrained liners, without compromising hip range of motion. The purpose of this study was to evaluate outcomes of revision THA using MDM. METHODS: The study was a multiinstitutional retrospective cohort study of 315 hips that underwent revision THA using MDM between 2011 and 2017. Clinical outcomes and reasons for failure were collected. RESULTS: Three hundred fifteen patients met 1-year minimum follow-up (mean 3.3 years). Nine hips had instability postoperatively (2.9%), and 30 hips required reoperation (9.5%). Seven had recurrent instability (6.5%) which was associated with liner-only exchange (P = .021) and liner outer diameter of ≤ 38 mm (P = .016). CONCLUSION: Revision THA with MDM provided a low rate of instability and reoperation in a revision cohort. Recurrent instability following use of MDM in revision THA was associated with retention of the acetabular component and polyethylene outer diameter ≤ 38 mm. LEVEL OF EVIDENCE: Therapeutic Level III.

Femoral side-only revision options for the Birmingham resurfacing arthroplasty.

BACKGROUND: The Birmingham Hip Resurfacing (BHR) system (Smith and Nephew) was developed as an alternative to conventional total joint replacement for younger, more active patients. Among other complications exists the risk for femoral component failure. The only marketed revision option for such a complication involves exchange of all components for a total replacement arthroplasty. This presents as a considerable and potentially unnecessary operative burden where revision of only the femoral prosthesis would suffice. We have analysed revision options for BHR in the context of periprosthetic femoral fractures with a stable acetabular component. METHODS: Technical details of dual mobility hip systems available in Australia were collated and analysed to assess for potential 'off label' use with an existing BHR acetabular component. These data were then compared with the custom-made Smith and Nephew dual mobility implant with respect to clearance and sizing. RESULTS: Two dual mobility articulation modalities from two companies were identified as appropriate for potential usage with four products analysed in detail. These two demonstrated acceptable sizing and clearance measurements. CONCLUSION: Comparison between readily available dual mobility prostheses with custom-made implants showed off label dual mobility prosthetic use to be a viable alternative for femoral-only revisions with in situ BHR. Single component revision has several advantages which include: a less complex surgical procedure, shorter operative time, decreased blood loss and the expectation of resultant lower morbidity. Furthermore, this less complex revision surgery should give comparable results to that of primary total hip arthroplasty.

Evaluation of the patellofemoral joint in total knee arthroplasty: Validation of the weight bearing merchant radiographic view.

BACKGROUND: Standard radiographic views for patellofemoral joint assessment do not reflect loading at which TKA patients may describe post-operative anterior symptoms. A novel weight bearing (WB) Merchant view has been described and demonstrated a number of tracking changes that correlated with clinical outcomes. In this study, we aim to validate the WB Merchant view and assess relationships with patient outcome scores. METHODS: Patients were randomly allocated to receive one of the three commonly used patellar implants with a single TKA prosthesis. Patients were evaluated at six months post-operatively using both NWB and WB Merchant views. Indicators of patellar tracking were correlated with improvement in KOOS, WOMAC and Kujala scores. For reliability assessment, radiographs were assessed twice by two readers. RESULTS: The WB Merchant view showed a reduction in the percentage of outliers of tracking indices in comparison to the NWB view (Congruence angle: NWB = 37%, WB = 24%; Displacement: NWB = 2%, WB = 0%; Tilt angle: NWB = 60%, WB = 56%). There was an increase in the lateral contact state with the WB Merchant view (Type I: NWB = 19%, WB = 28%; Type II: NWB = 3%, WB = 4%). The state of lateral contact had a consistent and statistically significant correlation with the improvement in KOOS, WOMAC and Kujala scores (p value = 0.01, 0.01 and 0.03, respectively). All radiographic indices had good reliability with accepted variability. CONCLUSION: The WB Merchant radiograph is an easy to perform and reliable view for the evaluation of patellar tracking and may provide additional information to the routinely used NWB view.

Surgery of complex craniofacial defects: A single-step AM-based methodology.

BACKGROUND AND OBJECTIVE: The purpose of the present paper is to pave the road to the systematic optimization of complex craniofacial surgical intervention and to validate a design methodology for the virtual surgery and the fabrication of cranium vault custom plates. Recent advances in the field of medical imaging, image processing and additive manufacturing (AM) have led to new insights in several medical applications. The engineered combination of medical actions and 3D processing steps, foster the optimization of the intervention in terms of operative time and number of sessions needed. Complex craniofacial surgical intervention, such as for instance severe hypertelorism accompanied by skull holes, traditionally requires a first surgery to correctly "resize" the patient cranium and a second surgical session to implant a customized 3D printed prosthesis. Between the two surgical interventions, medical imaging needs to be carried out to aid the design the skull plate. Instead, this paper proposes a CAD/AM-based one-in-all design methodology allowing the surgeons to perform, in a single surgical intervention, both skull correction and implantation. METHODS: A strategy envisaging a virtual/mock surgery on a CAD/AM model of the patient cranium so as to plan the surgery and to design the final shape of the cranium plaque is proposed. The procedure relies on patient imaging, 3D geometry reconstruction of the defective skull, virtual planning and mock surgery to determine the hypothetical anatomic 3D model and, finally, to skull plate design and 3D printing. RESULTS: The methodology has been tested on a complex case study. Results demonstrate the feasibility of the proposed approach and a consistent reduction of time and overall cost of the surgery, not to mention the huge benefits on the patient that is subjected to a single surgical operation. CONCLUSIONS: Despite a number of AM-based methodologies have been proposed for designing cranial implants or to correct orbital hypertelorism, to the best of the authors' knowledge, the present work is the first to simultaneously treat osteotomy and titanium cranium plaque.