Genome-based taxonomic identification and safety assessment of an Enterococcus strain isolated from a homemade dairy product.

The aim of this study was to explore the taxonomic identification and evaluate the safety of a bacterium, Enterococcus lactis IDCC 2105, isolated from homemade cheese in Korea, using whole genome sequence (WGS) analysis. It sought to identify the species level of this Enterococcus spp., assess its antibiotic resistance, and evaluate its virulence potential. WGS analysis confirmed the bacterial strain IDCC 2105 as E. lactis and identified genes responsible for resistance to erythromycin and clindamycin, specifically msrC, and eatAv, which are chromosomally located, indicating a minimal risk for horizontal gene transfer. The absence of plasmids in E. lactis IDCC 2105 further diminishes the likelihood of resistance gene dissemination. Additionally, our investigation into seven virulence factors, including hemolysis, platelet aggregation, biofilm formation, hyaluronidase, gelatinase, ammonia production, and ß-glucuronidase activity, revealed no detectable virulence traits. Although bioinformatic analysis suggested the presence of collagen adhesion genes acm and scm, these were not corroborated by phenotypic virulence assays. Based on these findings, E. lactis IDCC 2105 presents as a safe strain for potential applications, contributing valuable information on its taxonomy, antibiotic resistance profile, and lack of virulence factors, supporting its use in food products.

Key factors for the survival of Lactiplantibacillus plantarum IDCC 3501 in manufacturing and storage.

Functional microbiome development has steadily increased; with this, the viability of microbial strains must be maintained not only after the manufacturing process but also at the time of consumption. Survival is threatened by various unavoidable factors during freeze-drying and shelf storage. Here, the aim was to optimize the manufacturing process of the functional strain Lactiplantibacillus plantarum IDCC 3501 after freeze-drying and storage. Explosive growth was achieved using a medium composition with two nitrogen sources and a mineral, and growth was drastically improved by neutralizing the medium pH during the culture of L. plantarum IDCC 3501. Culture optimization involved a smaller cell size, leading to less intracellular free water. Moreover, when maltodextrin (MD) powder was directly added to the harvested cells, some intracellular free water was extracted from the bacterial cells, resulting in a dramatic increase in the viability of L. plantarum IDCC 3501 after freeze-drying and subsequent storage. Furthermore, MD enhanced survival in a dose-dependent manner. Bacterial survival was correlated with lysozyme tolerance; therefore, the positive result might have been caused by the osmotic dehydration of intracellular free water, which would potentially damage the bacterial cells via ice crystallization and/or a phase transition during freeze-drying. These critical factors of L. plantarum IDCC 3501 processing provide perspectives on survival issues for manufacturing microbiome strains. KEY POINTS: • Culture conditions for probiotic bacteria were optimized for high growth yield. • Osmotic dehydration improved bacterial survival after manufacturing and shelf storage. • Reduction in intracellular free water content is crucial for intact survival.

Minimum 19-Year Clinical Results and Patient Satisfaction After Total Knee Arthroplasty.

BACKGROUND: Long-term (minimum 19-year) outcome data on clinical results and patient satisfaction after posterior-stabilized total knee arthroplasties (TKAs) are missing in the literature. The purpose of the study was to evaluate the clinical and radiographic results as well as patient satisfaction at a mean of 21.2 years after posterior-stabilized TKAs. METHODS: This study included 756 patients (1,350 knees) who had undergone TKAs. There were 96 men and 660 women (mean age, 58 years; range, 40 to 84). The mean follow-up was 21.2 years (range, 19 to 23). At each follow-up visit, the patients were assessed radiographically and clinically. Furthermore, patient satisfaction was determined. RESULTS: The Knee Society total, pain, function, and deformity scores were 42, 18, 33, and 5 points, respectively, at the final follow-up. The mean Western Ontario and McMaster Universities Arthritis Index score was 25 points at the final follow-up. With revision or aseptic loosening as the end point, the 23-year intimated survival for the implant was 96% (95% confidence interval, 91 to 100%). The overall patient satisfaction score at the final follow-up was 83.3 points (range, 81 to 86). Patient satisfaction scores with regard to pain, housework, recreation, and surgery were 84, 81, 82, and 86 points, respectively. CONCLUSIONS: The findings of the present, mean 21-year follow-up clinical study suggest excellent results with regard to the revision rates and survivorship of the posterior-stabilized total knee implants. However, consistent with the literature, we found that about 80% of patients expressed overall satisfaction with their primary TKAs. About 8% of patients were either somewhat or very dissatisfied with the procedure.

Minimum 30-Year Results of Bilaterally Implanted Cemented and Cementless Total Hip Arthroplasty in Patients Younger Than 50 Years.

BACKGROUND: The rate of failure of cemented and cementless total hip arthroplasty (THA) in younger patients is higher than that in elderly patients. The purpose of this study is to document the long-term clinical results of THA with the so-called third-generation cementing and the results of second-generation cementless THA in patients <50 years of age. METHODS: This study included 106 patients who had had bilateral THA with a cemented stem in one hip and a cementless stem in the other. There were 78 men and 28 women. Their mean age was 47 years (range, 21-49). The average follow-up duration was 31 years (range, 30-32.5). RESULTS: There were similar mean Harris Hip Scores (90 versus 91 points) between the groups at the final follow-up. Forty-six acetabular components (43%) in the cemented group and 48 acetabular components (45%) in the cementless group were revised. Five femoral components (5%) in the cemented group and 4 femoral components (4%) in the cementless group were revised. Survivorship of the acetabular component at 30.8 years was similar in both groups (57% in the cemented group versus 55% in the cementless group). Survivorship of the femoral component at 30.8 years was also similar in both groups (95% in the cemented group versus 96% in the cementless group). CONCLUSION: Long-term fixation of the cemented or cementless femoral stem was outstanding. There was a high rate of the acetabular component revision due to conventional polyethylene wear and periacetabular osteolysis in both hybrid and fully cementless THA groups.

Is Highly Cross-Linked Polyethylene Safe for Use in High-Flexion Posterior Stabilized Total Knee Arthroplasty?

BACKGROUND: Application of highly cross-linked polyethylene (HXLPE) to a posterior cruciate-substituting total knee arthroplasty (TKA) might add the risk of fracture and failure of the tibial polyethylene insert. The purpose of this study is to evaluate the long-term (up to 19 years) clinical and radiographic results of posterior cruciate-substituting TKAs with HXLPE or conventional polyethylene. METHODS: This study analyzed the results of 1,217 patients (444 men and 773 women; mean age of 65 ± 7 years, range, 31-85) (2,434 knees) who had received a NexGen LPS-Flex prosthesis with a conventional tibial insert in one knee and the same prosthesis with an HXLPE tibial insert in the contralateral knee. The mean duration of follow-up was 17 years (range, 15-19). RESULTS: The 2 groups did not differ significantly (P > .05) with regard to the clinical and radiographic results. No knee in either group had a fracture of the tibial polyethylene post or failure of the locking mechanism of the tibial polyethylene insert or osteolysis. Twenty-eight knees (2.3%) in the HXLPE group and 26 knees (2.1%) in the conventional polyethylene group were revised. The estimated survival rate at 17 years was 97.7% in the HXLPE group and 97.9% in the conventional polyethylene group. CONCLUSION: The data suggest that clinical and radiographic findings at a mean of 17 years after posterior cruciate-substituting TKA are the same for patients treated with HXLPE and those treated with conventional polyethylene.

Long-Term Results (Minimum of 20 Years) of a Pure Proximal-Loading Metaphyseal-Fitting Anatomic Cementless Stem Without Distal Stem Fixation in Hip Arthroplasty.

BACKGROUND: There are no reported results for more than 20 years of a pure proximal-loading anatomic cementless femoral stem without diaphyseal stem fixation. The purpose of this study was to evaluate the long-term (minimum 20 years) clinical results, bone remodeling, revision rate, and survivorship of these implants in patients aged less than 60 years. METHODS: We included 523 patients (657 hips), including 319 men and 204 women. The mean body mass index was 26.7 (range, 23-29 kg/m2). The mean age of patients at index surgery was 55 years (range, 20-59 years). The Harris Hip Score, the Western Ontario and McMaster Universities Osteoarthritis Index, and the University of California, Los Angeles activity score were recorded preoperatively and at each follow-up. Mean follow-up was 23.5 years (range, 20-27 years). RESULTS: The Harris Hip Score at the final follow-up was a mean 93 points (range, 70-100 points). The Western Ontario and McMaster Universities Osteoarthritis Index and University of California, Los Angeles activity scores at the final follow-up were 16 and 7.6 points, respectively. Five femoral components (0.8%) and 13 acetabular components (2.0%) were revised. All cases in the current series had grade 2 stress shielding; no hips had grade 3 or 4 stress shielding. Kaplan-Meier survivorship of the implants at 23.5 years was 98.0% (95% confidence interval 92%-100%) for the acetabular component and 99.2% (95% confidence interval 93%-100%) for the femoral component. CONCLUSION: A pure proximal-loading metaphyseal-fitting anatomic cementless stem with alumina-on-alumina ceramic bearing couples functioned well, with no osteolysis or mild stress-shielding at an average 23.5-year follow-up.

Long-Term (up to 38 Years) Failure Modes of Total Hip Arthroplasty in Adult Patients Who Had Childhood Infection of Hip.

BACKGROUND: The long-term failure modes of total hip arthroplasty (THA) in adult patients who had childhood infection have not been documented. The purpose of this study is to analyze the longer term clinical and radiographic results, prevalence of osteolysis, and survival rate of THA. METHODS: We reviewed the results of 142 patients (145 hips) (mean age 41.9 years). The age of the patients at the time that the infection was contracted was an average of 7.1 years (range 1-11). The average interval between active infection and THA was 34.5 years. All but 2 hips (1 patient) had a quiescent period of infection of more than 10 years. The average duration of follow-up after THA was 31.5 years (range 25-38). RESULTS: All but 2 hips with more than 10 years of quiescent infection had no recurrence of infection. The remaining 2 hips in the 1 patient with only 7 years of quiescent infection had a recurrence of infection. Seventy-eight of 145 hips (54%) underwent isolated cup revision for loosening, or osteolysis, or dislocation. Thirty (21%) femoral components were revised for aseptic loosening and/or osteolysis. The Kaplan-Meier survivorship curve at 31.5 years showed that the survival rate of the acetabular component was 46% (95% confidence interval 39-74) and that of the femoral component was 79% (95% confidence interval 73-89). CONCLUSION: Contributing factors to the high failure rate of THAs were less than optimal prostheses and poor quality of polyethylene during the time period of this study.

Long-Term Follow-Up of Management of the Hypoplastic Femur With Femoral Episiotomy and Onlay Allograft During Total Hip Arthroplasty.

BACKGROUND: To insert the regular-sized stem for a dysplastic femoral canal, controlled episiotomy of the femur can be performed. The purpose of this study is to determine the long-term (up to 19 years) results of total hip arthroplasties (THAs) using strut allografts combined with an episiotomy over an extensively porous-coated stem. METHODS: We reviewed the results of 65 total hip arthroplasties in 63 patients (mean age 42.1 years; range 21-61) with dysplastic femur after childhood sepsis. The patients were treated using controlled episiotomy of the femur to widen the femoral canal, extensively porous-coated femoral stems, and cortical strut allografts because primary axial or rotational stability could not be achieved without grafting. The mean follow-up was 17.1 years (range 15-19). RESULTS: The mean Harris Hip Score at the final follow-up was 85 ± 15 points (range 45-100). The mean Western Ontario and McMaster Universities Osteoarthritis Index score was 23 ± 15 points (range 13-53). The mean University of California, Los Angeles score was 6.3 points (range 5-8). A Kaplan-Meier survivorship analysis at 19 years of follow-up showed that the survival rate of the femoral components was 92% (95% confidence interval 89-98), and it was 88% (95% confidence interval 85-92) for the acetabular component with aseptic loosening or revision for any reason. CONCLUSION: We found good results in terms of longevity and functional outcome using this technique. Future mechanical studies, in addition to controlled clinical studies, are warranted.

Does an Ultra-Short Anatomic Cementless Femoral Stem Improve Long-Term (Up to 17 Years) Results in Patients Younger Than 30 Years?

BACKGROUND: The purpose of this long-term (up to 17 years) follow-up study was to determine: (1) clinical results and evidence of clicking or squeaking sounds; (2) radiographic results, including rates of osseointegration, bone remodeling, and osteolysis; (3) rates of complications including thigh pain, periprosthetic fracture, and ceramic fracture; (4) rates of revision; and (5) survival rates of implants in patients younger than 30 years. METHODS: We analyzed the results of 240 consecutive primary total hip arthroplasty in 180 patients (118 men and 62 women who had a mean age of 27 years (range, 21 to 30 years)). The mean follow-up was 16 years (range, 14 to 17 years). RESULTS: Mean Harris hip score, Western Ontario and McMaster Universities score, and University of California, Los Angeles activity score were 93 points, 18 points, and 7 points, respectively, at final follow-up. Radiographically, all of the acetabular components and all but two femoral components were well-fixed at the final follow-up. No hip had osteolysis or exhibited Grade 3 stress shielding. All but two patients had no groin or thigh pain. No hip had a periprosthetic or ceramic fracture. Eight hips (3%) exhibited squeaking sounds. Two acetabular components and two femoral stems were revised. The survival of the acetabular and femoral component was 99.2% (95% confidence interval, 94 to 100%). CONCLUSION: The results of the present long-term study of ultra-short anatomic cementless femoral stems suggest excellent clinical and radiographic results in patients younger than 30 years.

Long-Term Clinical and Radiographic Results of an Ultra-Short Metaphyseal-Fitting Non-Anatomic Cementless Stem in Patients with Femoral Neck Fracture.

BACKGROUND: The purpose of this study is to determine the clinical and radiographic outcomes, mortality rate, complication rate, and revision rate of this ultra-short non-anatomic cementless femoral stem in elderly patients with a femoral neck fracture. METHODS: We reviewed the results of 284 total hip arthroplasties performed with an ultra-short non-anatomic cementless stem in 280 previously active patients with a mean age of 72.8 ± 13 years (range 49-83). The mean follow-up was 9.3 years (range 7-13). RESULTS: The mean Harris Hip Score was 86 ± 14 points at final follow-up. The mean Western Ontario and McMaster Universities Osteoarthritis Index score was 24 ± 6 points at the final follow-up. The mean University of California, Los Angeles activity score was 6 points at final follow-up. Osseointegration was seen in all acetabular (100%) and in 276 femoral components (97%). Kaplan-Meier survivorship analysis revealed that the survival rate of the femoral component at 8.3 years was 97% (95% confidence interval 91-100) and that of the acetabular component was 100% (95% confidence interval 94-100) with aseptic loosening or revision as the end point. CONCLUSION: An ultra-short non-anatomic cementless femoral stem in patients with good bone quality (Dorr A and some Dorr type B bone) is a safe treatment for femoral neck fracture. In patients with poor bone quality (Dorr C type), the results were very poor, and use of this stem should be avoided.

Combined Strut Onlay Allografting, Reduction Osteotomy, and Extensively Porous-Coated Stem for Reconstruction of Severe Femoral Defects During Revision Hip Arthroplasty.

BACKGROUND: The purpose of this study is to determine the long-term (up to 27 years) results of a modified technique applying strut allografts combined with a reduction osteotomy over an extensively porous-coated stem. METHODS: We reviewed the results of 399 revision total hip arthroplasties (for aseptic loosening in 390 hips and septic loosening in 9 hips) in 369 patients (mean age 58 ± 13 years, range 22-65) performed with an extensively porous-coated femoral stem combined with a cortical strut onlay allograft. The mean follow-up was 23 years (range 20-27). RESULTS: The mean Harris Hip Score was 84 ± 16 points (range 35-100) at the final follow-up. The mean Western Ontario and McMaster Universities Osteoarthritis Index score was 21 ± 16 points (range 12-53) at the final follow-up. The mean University of California Los Angeles activity score was 6.1 points (range 5-8). A Kaplan-Meier survivorship analysis at 23 years of follow-up showed that the survival rate of the femoral component was 95.5% (95% confidence interval 89-98) with aseptic loosening or revision for any reason and it was 91.5% (95% confidence interval 85-95) if septic loosening was included. CONCLUSION: We found good results in terms of longevity and functional outcome using this modified technique. Future mechanical studies in addition to controlled clinical studies are warranted.

The 22 to 25-Year Survival of Cemented and Cementless Total Knee Arthroplasty in Young Patients.

BACKGROUND: Despite cementless total knee arthroplasties (TKAs) have potential advantages over cemented TKAs, there are conflicting results. The purpose of the present study is to determine the long-term clinical and radiographic results, the survival rate, and the prevalence of osteolysis of cemented vs cementless TKAs. METHODS: A total of 261 patients (522 knees) who underwent bilateral simultaneous TKAs were included in the present study (mean age, 62.5 ± 5.5 years). Patients were evaluated clinically, radiographically, and also using computed tomography scans. A mean follow-up period was 23.8 years (range, 22-25 years). RESULTS: There were no significant differences between the Knee Society total score, change in total score, knee function score, and Western Ontario and McMaster Universities Osteoarthritis Index score in the 2 groups. In total, 8 knees (3%) were revised in the cementless group and 5 knees (2%) in the cemented group. Radiographs and computed tomography scans showed no femoral, tibial, or patellar osteolysis in either group. The rate of survival at 25 years was 97% (95% confidence interval [CI], 92%-100%) in the cementless group and 98% (95% CI, 94%-100%) in the cemented group, with reoperation for any reason as the end point. The rate of survival at 25 years was 98% (95% CI, 94%-100%), with reoperation for aseptic loosening as the end point in both groups. CONCLUSIONS: At this length of follow-up, cementless TKA has comparable outcomes and survivorship to cemented TKA.

20-Year Minimum Outcomes and Survival Rate of High-Flexion Versus Standard Total Knee Arthroplasty.

BACKGROUND: There are conflicting reports of early and mid-term results of the high-flexion total knee arthroplasties (TKAs). The purpose of the present long-term follow-up study was to determine the long-term (minimum 20 years) clinical and radiographic and CT scan results, and the survival rates of high-flexion versus standard TKAs. METHODS: Ninety-five patients (190 knees) were included (mean age, 65 ± 6.5 years). The mean follow-up was 20.3 years (range, 20 to 20.6 years). RESULTS: Revision of the TKA was performed in 5 knees (5.2%) with high-flexion TKA and in 3 knees (3.2%) with standard TKA. The rate of survival at 20 years was 94.8% (95% CI, 91%-98%) in the high-flexion TKA group and 96.8% (95% CI, 92%-100%) in the standard TKA group with reoperation for any reason. No knee had osteolysis in either group. CONCLUSIONS: At this length of follow-up, high-flexion TKA has comparable outcomes and survivorship to standard TKA.

A Prospective, Randomized Comparison of the Long-Term Clinical and Radiographic Results of an Ultra-Short vs a Conventional Length Cementless Anatomic Femoral Stem.

BACKGROUND: The purpose of this study is to compare the long-term clinical and radiographic results, survival rates, and complication rates of an ultra-short vs a conventional length cementless anatomic femoral stem. METHODS: We reviewed 759 patients (858 hips) (mean age, 56.3 ± 12.9 y) who had an ultra-short cementless anatomic stem and 759 patients (858 hips) (mean age, 54.8 ± 12.3 y) who had a conventional length cementless anatomic stem. The mean follow-up was 16.5 years (range 14-17) in the ultra-short stem group and 17.5 years (range 17-20) in the conventional stem group. RESULTS: At the latest follow-up, there were no significant differences between the 2 groups in terms of the Harris Hip Scores (92 ± 6 vs 91 ± 7 points, P = .173), Western Ontario and McMaster Universities Osteoarthritis scores (12 ± 8 vs 13 ± 7 points, P = .972), University of California Los Angeles activity scores (7.6 vs 7.8 points, P = .841), patient satisfaction scores (7.7 ± 2.3 vs 7.5 ± 2.5 points, P = .981), and survival rates (97.6% vs 96.6%). However, incidence of thigh pain (P = .031) and stress shielding (P = .001) was significantly higher in the conventional length stem group than in the ultra-short anatomic stem group. Complication rates were similar (1.8% vs 2.7%) between the 2 groups. CONCLUSION: Although an ultra-short cementless anatomic femoral stem confers equivalent clinical and radiographic outcomes, survival rates, and complication rates to conventional length cementless anatomic stem, the incidence of thigh pain and stress shielding was significantly lower in the ultra-short cementless anatomic stem. LEVEL OF EVIDENCE: Therapeutic Level I.

Long-Term Survival (up to 34 Years) of Retained Cementless Anatomic Femoral Stem in Patients <50 Years Old.

BACKGROUND: There is a paucity of studies longer than 30 years to determine clinical and radiographic results of retained cementless anatomic stem. The purpose of this study is to determine the long-term (up to 34 years) survival rate of the retained cementless anatomic femoral stem in patients <50 years of age. METHODS: Isolated cup revision was performed with retaining primary cementless anatomic femoral stem in 206 patients (149 men and 57 women). Clinical and radiographic results were monitored at each follow-up. At the latest follow-up, computed tomography scans were carried out in all hips to determine the prevalence of osteolysis. The mean follow-up of the retained femoral stem was 30.3 years (range 27-34). The mean follow-up of the revised cup was 25.5 years (range 22-29). RESULTS: The mean Harris Hip Score was 91 ± 7.8 points (range 71-100) and the mean Western Ontario and McMaster Universities Osteoarthritis score was 16 ± 7 points (range 7-34) at the final follow-up. The mean University of California, Los Angeles activity score was 7 ± 4 points (range 5-10) at the final follow-up. The overall survival rate of retained cementless femoral stems was 98.9% (95% confidence interval 91-100) at 30.3 years. The survival rate of the revised cup was 93% (95% confidence interval 89-98) at 25.5 years. CONCLUSION: The rate of aseptic loosening of already osseointegrated femoral stem remains low with ceramic-on-ceramic bearing in young active patients.

Long-Term (Up to 27 Years) Prospective, Randomized Study of Mobile-Bearing and Fixed-Bearing Total Knee Arthroplasties in Patients <60 Years of Age With Osteoarthritis.

BACKGROUND: Our study determined long-term (up to 27 years) results of fixed-bearing vs mobile-bearing total knee arthroplasties (TKAs) in patients <60 years with osteoarthritis. METHODS: This study included 291 patients (582 knees; mean age 58 ± 5 years), who received a mobile-bearing TKA in one knee and a fixed-bearing TKA in the other. The mean duration of follow-up was 26.3 y (range 24-27). RESULTS: At the latest follow-up, the mean Knee Society knee scores (91 ± 9 vs 89 ± 11 points, P = .383), Western Ontario and McMaster Universities Osteoarthritis Index (35 ± 7 vs 37 ± 6 points, P = .165), range of knee motion (128° ± 13° vs 125° ± 15°, P = .898), and University of California, Los Angeles activity score (6 ± 4 vs 6 ± 4 points, P = 1.000) were below the level of clinical significance between the 2 groups. Revision of mobile-bearing and fixed-bearing TKA occurred in 16 (5.5%) and 20 knees (6.9%), respectively. The rate of survival at 27 years for mobile-bearing and fixed-bearing TKA was 94.5% (95% confidence interval 89-100) and 93.1% (95% confidence interval 88-98), respectively, and no significant differences were observed between the groups. Osteolysis was identified in 4 knees (1.4%) in each group. CONCLUSION: There were no significant differences in functional outcomes, rate of loosening, osteolysis, or survivorship between the 2 groups.

A randomized trial of Lactobacillus rhamnosus IDCC 3201 tyndallizate (RHT3201) for treating atopic dermatitis.

BACKGROUND: Probiotic therapies, mainly live bacteria, have been proven to be effective in treating atopic dermatitis (AD) with some controversies. Killed probiotics or postbiotics would have immunomodulatory effect in allergic diseases including AD. This study was performed to evaluate the therapeutic effect and safety of tyndallized Lactobacillus rhamnosus (IDCC 3201, isolated from the feces of a Korean breastfed infant, repeated heat-treated and incubated, RHT3201) in children with AD. METHODS: In a randomized, double-blind, placebo-controlled study, RHT3201 at a dose of 1.0 × 1010  CPU/d or placebo was given in children (aged 1-12 years) with moderate AD for 12 weeks. SCORing of AD (SCORAD) scores, allergic inflammatory markers, and safety parameters were evaluated. RESULTS: For evaluating the therapeutic effects of RHT3201, 33 subjects in each group were analyzed. The change of SCORAD total score at 12 weeks (primary outcome) from baseline was significantly greater in the RHT3201 group (-13.89 ± 10.05) compared to the control group (-8.37 ± 9.95). Levels of eosinophil cationic protein (ECP) and interleukin (IL)-31 showed tendency to decrease in the RHT3201 group and significant decreases in subgroup analysis in AD for ≥50 months. For safety analysis, a total of 100 subjects (50 in the treated group and 50 in the control group) were evaluated, and there were no significant differences in safety parameters between two groups. CONCLUSION: In children with moderate AD, oral administration of RHT3201 showed the therapeutic effect on AD, the effects in part correlated with decrement of ECP and IL-31, and the effect was more remarkable in subgroup analysis.

Does Robotic-assisted TKA Result in Better Outcome Scores or Long-Term Survivorship Than Conventional TKA? A Randomized, Controlled Trial.

BACKGROUND: Robotic-assisted TKA was introduced to enhance the precision of bone preparation and component alignment with the goal of improving the clinical results and survivorship of TKA. Although numerous reports suggest that bone preparation and knee component alignment may be improved using robotic assistance, no long-term randomized trials of robotic-assisted TKA have shown whether this results in improved clinical function or survivorship of the TKA. QUESTIONS/PURPOSES: In this randomized trial, we compared robotic-assisted TKA to manual-alignment techniques at long-term follow-up in terms of (1) functional results based on Knee Society, WOMAC, and UCLA Activity scores; (2) numerous radiographic parameters, including component and limb alignment; (3) Kaplan-Meier survivorship; and (4) complications specific to robotic-assistance, including pin-tract infection, peroneal nerve palsy, pin-site fracture, or patellar complications. METHODS: This study was a registered prospective, randomized, controlled trial. From January 2002 to February 2008, one surgeon performed 975 robotic-assisted TKAs in 850 patients and 990 conventional TKAs in 849 patients. Among these patients 1406 patients were eligible for participation in this study based on prespecified inclusion criteria. Of those, 100% (1406) patients agreed to participate and were randomized, with 700 patients (750 knees) receiving robotic-assisted TKA and 706 patients (766 knees) receiving conventional TKA. Of those, 96% (674 patients) in the robotic-assisted TKA group and 95% (674 patients) in the conventional TKA group were available for follow-up at a mean of 13 (± 5) years. In both groups, no patient older than 65 years was randomized because we anticipated long-term follow-up. We evaluated 674 patients (724 knees) in each group for clinical and radiographic outcomes, and we examined Kaplan-Meier survivorship for the endpoint of aseptic loosening or revision. Clinical evaluation was performed using the original Knee Society knee score, the WOMAC score, and the UCLA activity score preoperatively and at latest follow-up visit. We also assessed loosening (defined as change in the position of the components) using plain radiographs, osteolysis using CT scans at the latest follow-up visit, and component, and limb alignment on mechanical axis radiographs. To minimize the chance of type-2 error and increase the power of our study, we assumed the difference in the Knee Society score to be 25 points to match the MCID of the Knee Society score with a SD of 5; to be able to detect a difference of this size, we calculated that a total of 628 patients would be needed in each group in order to achieve 80% power at the α = 0.05 level. RESULTS: Clinical parameters at the latest follow-up including the Knee Society knee scores (93 ± 5 points in the robotic-assisted TKA group versus 92 ± 6 points in the conventional TKA group [95% confidence interval 90 to 98]; p = 0.321) and Knee Society knee function scores (83 ± 7 points in the robotic-assisted TKA group versus 85 ± 6 points in the conventional TKA group [95% CI 75 to 88]; p = 0.992), WOMAC scores (18 ± 14 points in the robotic-assisted TKA group versus 19 ± 15 points in the conventional TKA group [95% CI 16 to 22]; p = 0.981), range of knee motion (125 ± 6° in the robotic-assisted TKA group versus 128 ± 7° in the conventional TKA group [95% CI 121 to 135]; p = 0.321), and UCLA patient activity scores (7 points versus 7 points in each group [95% CI 5 to 10]; p = 1.000) were not different between the two groups at a mean of 13 years' follow-up. Radiographic parameters such as the femorotibial angle (mean 2° ± 2° valgus in the robotic-assisted TKA group versus 3° ± 3° valgus in the conventional TKA group [95% CI 1 to 5]; p = 0.897), femoral component position (coronal plane: mean 98° in the robotic-assisted TKA group versus 97° in the conventional TKA group [95% CI 96 to 99]; p = 0.953; sagittal plane: mean 3° in the robotic-assisted TKA group versus 2° in the conventional TKA group [95% CI 1 to 4]; p = 0.612) and tibial component position (coronal plane: mean 90° in the robotic-assisted TKA group versus 89° in the conventional TKA group [95% CI 87 to 92]; p = 0.721; sagittal plane: 87° in the robotic-assisted TKA group versus 86° in the conventional TKA group [95% CI 84 to 89]; p = 0.792), joint line (16 mm in the robotic-assisted TKA group versus 16 mm in the conventional TKA group [95% CI 14 to 18]; p = 0.512), and posterior femoral condylar offset (24 mm in the robotic-assisted TKA group versus 24 mm in the conventional TKA group [95% CI 21 to 27 ]; p = 0.817) also were not different between the two groups (p > 0.05). The aseptic loosening rate was 2% in each group, and this was not different between the two groups. With the endpoint of revision or aseptic loosening of the components, Kaplan-Meier survivorship of the TKA components was 98% in both groups (95% CI 94 to 100) at 15 years (p = 0.972). There were no between-group differences in terms of the frequency with which complications occurred. In all, 0.6% of knees (four) in each group had a superficial infection, and they were treated with intravenous antibiotics for 2 weeks [corrected]. No deep infection occurred in these knees. In the conventional TKA group, 0.6% of knees (four) had motion limitation (< 60°) [corrected]. CONCLUSIONS: At a minimum follow-up of 10 years, we found no differences between robotic-assisted TKA and conventional TKA in terms of functional outcome scores, aseptic loosening, overall survivorship, and complications. Considering the additional time and expense associated with robotic-assisted TKA, we cannot recommend its widespread use. LEVEL OF EVIDENCE: Level I, therapeutic study.

Comparison of Modular Conventional and High-Flexion Posterior-Stabilized Total Knee Arthroplasties in the Same Patients at a Mean Follow-Up of 15 Years.

BACKGROUND: As previous studies are limited to short-term clinical data on conventional and high-flexion total knee arthroplasties (TKAs), long-term clinical data on these TKAs remain unclear. Therefore, we evaluated long-term functional outcome, range of knee motion, revision rate, implant survival, and the prevalence of osteolysis after conventional and high-flexion TKAs in the same patients. METHODS: The authors evaluated a cohort of 1206 patients with a mean age of 65.3 ± 7 years (range: 22-70) who underwent bilateral simultaneous sequential TKAs. One knee received a conventional TKA and the other received a high-flexion TKA. The mean duration of follow-up was 15.6 years (range: 14-17). RESULTS: No significant differences were found between the 2 groups at the latest follow-up with respect to Knee Society score (93 vs 92 points, P = .765), pain score (45 vs 44 points, P = .641), range of knee motion (125° vs 126°, P = .712), and radiographic and computed tomography scan results. Furthermore, no significant revision rate differences were found between the 2 groups (1.3% for conventional TKA vs 1.6% for high-flexion TKA; P = .137). There was no osteolysis recorded in either group. The rate of survivorship free of implant revision or aseptic loosening was 98.7% (95% CI = 91-100) for conventional TKA and 98.4% (95% CI = 91-100) for high-flexion TKA at 17 years. CONCLUSION: At the latest follow-up, we were not able to demonstrate any significant difference between conventional and high-flexion TKAs with respect to functional outcome scores, range of knee motion, revision rate, implant survival, and prevalence of osteolysis.

Ultra-Short Anatomic Uncemented Femoral Stem and Ceramic-on-Ceramic Bearing in Patients With Idiopathic or Ethanol-Induced Femoral Head Osteonecrosis.

BACKGROUND: Long-term result of the ultra-short anatomic cementless stem in the patients with idiopathic or ethanol-induced osteonecrosis of the femoral head has not been assessed. The aim of this study is to evaluate the long-term clinical, radiographic, computed tomography scan, and dual-energy X-ray absorptiometry scanning results, and survivorship of this specific femoral stem in patients with idiopathic or ethanol-induced femoral head osteonecrosis. METHODS: Two hundred fifty-six patients (335 hips) with an average age of 49.8 years (range 20-63) were enrolled in the current study. All patients underwent dual-energy X-ray absorptiometry scanning of the acetabulum and proximal femur preoperatively and at final follow-up. Computed tomography scan was obtained in all patients at final follow-up. The mean follow-up was 14.7 years (range 13-16). RESULTS: At final follow-up, the average Harris hip score, Western Ontario and McMaster Universities Osteoarthritis Index score, and University of California, Los Angeles activity score were 94 points, 12 points, and 8 points, respectively. Four stems (1%) underwent revision for aseptic loosening. One acetabular component (0.3%) was revised for recurrent dislocation. No hip was revised for squeaking or clicking sound. Survivorship of the femoral stem was 99.0% (95% confidence interval 94-100) and that of the acetabular component was 99.4% (95% confidence interval 95-100) at 14.7 years. CONCLUSION: Ultra-short proximal loading anatomic uncemented femoral stems with ceramic-on-ceramic bearings have excellent survivorship free from aseptic loosening and good clinical results at long term. LEVEL OF EVIDENCE: Level IV.