Risk factors for early septic failure after two-stage exchange total knee arthroplasty for treatment of periprosthetic joint infection.

BACKGROUND: The cause of early septic failure after two-stage exchange revision total knee arthroplasty (TKA) for chronic periprosthetic joint infection (PJI) and the factors affecting it are not well known. The purpose of this study was to determine the surgical outcomes and the risk factors for early septic failure after two-stage revision TKA for chronic PJI. METHODS: We identified a total of 246 adult patients who met the Musculoskeletal Infection Society (MSIS) diagnostic criteria for chronic PJI at two academic tertiary hospitals from March 2012 to December 2018. Finally, 151 patients who consecutively received two-stage exchange revision TKA for chronic PJI and who had a minimum 3-year follow-up were enrolled and retrospectively reviewed. Successful surgical treatment was evaluated for two-stage revision TKA and risk factors for early septic failure were identified. RESULTS: Early septic failures occurred within 3 years after reimplantation in 48 patients (31.8%). After accounting for potentially confounding variables, we found that male patient [odds ratio (OR): 2.753, 95% confidence interval (CI) 1.099-6.893, p = 0.031], fungus or mycobacterial infection (OR: 5.224, 95% CI 1.481-18.433, p = 0.01), and positive culture at reimplantation (OR: 4.407, 95% CI 1.255-15.480, p = 0.021) were independently associated with early septic failure after two-stage exchange revision TKA. CONCLUSION: Male patients, fungus or mycobacterial infection, and positive culture at reimplantation were independently associated with an increased risk of early septic failure after two-stage exchange revision TKA despite normal C-reactive protein values prior to reimplantation. Further prospective and high-quality studies are needed to determine the risk factors of two-stage exchange revision TKA for chronic PJI. LEVEL OF EVIDENCE: level IV; retrospective comparison; treatment study.

Clinical Efficacy and Safety of the Intra-articular Injection of Autologous Adipose-Derived Mesenchymal Stem Cells for Knee Osteoarthritis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Intra-articular injection of autologous culture-expanded adipose-derived mesenchymal stem cells (ADMSCs) has introduced a promising treatment option for knee osteoarthritis. Although the clinical efficacy and safety of ADMSCs have been reported, the treatment remains controversial owing to the small sample sizes and heterogeneous osteoarthritis grades in previous studies. PURPOSE: To assess the efficacy and safety of intra-articular injection of ADMSCs as compared with placebo in alleviating pain and improving functional capacity in a large sample of patients with knee osteoarthritis of Kellgren-Lawrence (K-L) grade 3. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This phase III multicenter clinical trial was a double-blind randomized controlled study that included 261 patients with K-L grade 3 symptomatic knee osteoarthritis who were administered a single injection of autologous culture-expanded ADMSCs or placebo. Clinical data were assessed at baseline and at 3 and 6 months after the injection. The primary endpoints were improvements in 100-mm visual analog scale (VAS) for pain and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for function at 6 months after the injection. The secondary endpoints included clinical and radiologic examinations and safety after injection. The changes in cartilage defects after injection were assessed by magnetic resonance imaging at 6 months. RESULTS: The ADMSC and control groups included 125 and 127 patients available for follow-up, respectively. At 6 months, the ADMSC group showed significantly better improvements in 100-mm VAS (ADMSC vs control, 25.2 vs 15.5; P = .004) and total WOMAC score (21.7 vs 14.3; P = .002) as compared with the control group. The linear mixed model analysis indicated significantly better improvements in all clinical outcomes in the ADMSC group after 6 months. At 6 months, the ADMSC group achieved significantly higher proportions of patients above the minimal clinically important difference in 100-mm VAS and WOMAC score. Radiologic outcomes and adverse events did not demonstrate significant differences between the groups. No serious treatment-related adverse events were observed. Magnetic resonance imaging revealed no significant difference in change of cartilage defects between the groups at 6 months. CONCLUSION: Intra-articular injection of autologous culture-expanded ADMSCs provided significant pain relief and functional improvements in patients with K-L grade 3 osteoarthritis. Long-term results are needed to determine the disease-modifying effects of ADMSCs, such as structural changes, and the duration of effect of intra-articular injection of ADMSCs in knee osteoarthritis. REGISTRATION: NCT03990805 (ClinicalTrials.gov identifier).

Silicone ring tourniquet could be a substitute for a conventional tourniquet in total knee arthroplasty with a longer surgical field: a prospective comparative study in simultaneous total knee arthroplasty.

INTRODUCTION: This study aimed to compare the clinical outcomes of silicon ring tourniquets and conventional pneumatic tourniquets in total knee arthroplasty (TKA). The study compared the operation time, total bleeding amount, length from the tourniquet distal end to the patella superior pole (L_TP), and complications related to the two tourniquet application methods and attempted to determine whether the silicon ring tourniquet has advantages over conventional pneumatic tourniquets. MATERIALS AND METHODS: This prospective comparative study included 30 patients who underwent bilateral simultaneous TKA for degenerative osteoarthritis in August to December 2021. All patients underwent TKA on one side with a conventional pneumatic tourniquet, while TKA on the other side with a silicon ring tourniquet. The primary outcomes were the L_TP, operation time, tourniquet time, total bleeding amount, total drainage amount, and postoperative visual analog scale (VAS) score of the tourniquet applied site at 6, 24, and 48 h postoperatively. The secondary outcome was tourniquet-related complications in both groups. RESULTS: L_TP was significantly longer in the silicon ring tourniquet group compared with that in the pneumatic tourniquet group (20.22 ± 2.74 cm versus 15.12 ± 2.40, p < 0.001). No significant difference was found in other results. The tourniquet applied site pain was less in the silicon ring tourniquet group (p = 0.037). CONCLUSIONS: Silicon ring tourniquet application resulted in better clinical outcomes than conventional pneumatic tourniquets in TKA. Because we can obtain a wider surgical field using silicon ring tourniquets without complications, silicon ring tourniquets could be a substitute for conventional pneumatic tourniquets in total knee arthroplasty or distal femoral surgeries.

Evaluation of lateral and anterior center-edge angles according to sex and anterior pelvic plane tilt angle: a three-dimensional quantitative analysis.

BACKGROUND: This study aimed to quantitatively evaluate lateral center-edge angle (LCEA) and anterior center-edge angle (ACEA) according to sex and the anterior pelvic plane (APP) tilt angle and analyze the correlation between these measurements and acetabular coverage. METHODS: Computed tomography scans of 71 adults (38 men and 33 women) with normal hip joints were obtained. LCEA, anterior ACEA, and acetabular coverage were measured with APP tilt every 5° from - 30° to + 30° and were compared between the sexes. The correlation between acetabular coverage and LCEA/ACEA was also analyzed. RESULTS: (1) LCEA, ACEA, and acetabular coverage were statistically larger in men than in women at all APP tilt angles (with the exception of acetabular coverage ≥ 25°). (2) LCEA, ACEA, and acetabular coverage differed according to APP tilt angle. LCEA and acetabular coverage showed maximum values at 10°. ACEA showed a tendency to increase by an average of 3.6° for every 5° increase in the APP tilt angle. LCEA demonstrated strong and very strong associations across all APP tilting angles, whereas ACEA showed a moderate association at angles ≥ 15° in men and ≥ 30° in women. CONCLUSIONS: The LCEA and ACEA are adequate measurement methods that reflect actual acetabular coverage unless the pelvis is tilted excessively anteriorly. While pelvic tilting does not need to be considered for LCEA within the physiologic range, it should always be taken into account for ACEA, as it increases by an average of 3.6° for every 5° increase in APP tilt angle. LEVEL OF EVIDENCE: Level III: retrospective cohort study.

Sex differences in the anatomy of the anterior-superior acetabular rim in relation to pincer-type femoroacetabular impingement in Koreans: a three-dimensional quantitative analysis.

PURPOSE: The aim of this study was to compare the anatomical structures of the acetabular rim around the anterior inferior iliac spine (AIIS) ridge that indicate anterior focal coverage of acetabulum between the sexes using a three-dimensional (3D) model. METHODS: 3D models of 71 adults (38 men and 33 women) with normal hip joints were used. Based on the location of the inflection point (IP) of the acetabular rim around the AIIS ridge, the patients were classified into anterior and posterior types, and the ratios thereof for each sex were compared. Coordinates for the IP, the most anterior point (MAP), and the most lateral point (MLP) were obtained and compared between the sexes and between anterior and posterior types. RESULTS: Coordinates for IPs in men were located anterior and inferior to those in women. MAP coordinates for men were located inferior to those for women, and MLP coordinates for men were located lateral and inferior to those for women. Comparing AIIS ridge types, we noted that coordinates for IPs of the anterior type were located medial, anterior, and inferior to those of the posterior type. Meanwhile, MAP coordinates of the anterior type were located inferior to those of the posterior type, and MLP coordinates of the anterior type were located lateral and inferior to those of the posterior type. CONCLUSION: Anterior focal coverage of the acetabulum appears to differ between the sexes, and this difference may affect the development of pincer-type femoroacetabular impingement (FAI). Additionally, we found that anterior focal coverage differs according to anterior or posterior positioning of the bony prominence around the AIIS ridge, which may affect development of FAI.

The influence of radiologic bone transparency after hybrid total knee arthroplasty on clinical outcomes: Minimum 6-year follow up of 214 cases.

BACKGROUND: This study aimed to investigate how bone transparency affects loosening of the cementless femoral component by serially analyzing radiologic images in hybrid total knee arthroplasty (TKA). METHODS: A total of 214 cases of TKA performed using the hybrid technique that were followed up for at least 6 years were retrospectively investigated. Bone transparency around the femoral component during the follow up period was evaluated. All TKA cases were divided into two groups and compared: those with radiologic bone transparency (bone transparency group, n = 51) and those without radiologic bone transparency (no bone transparency group, n = 163). RESULTS: The incidence of revision TKA in all patients was 6.1%, and obesity, preoperative and postoperative mechanical alignment did not affect surgical outcomes. All bone transparency cases were asymptomatic, and only 8/51 cases (15.7%) of bone transparency spontaneously resolved. Between the bone transparency and no bone transparency groups, there was no difference found in the preoperative and postoperative radiologic parameters and clinical outcomes. During the follow up period, there were four (1.9%) cases with a definite radiolucent line in the femoral component, all of which belonged to the bone transparency group. CONCLUSIONS: The bone transparency around the femoral component that appears on radiography after hybrid TKA could be an early sign of aseptic loosening; therefore, follow up serial radiography is essential.

Multiple Drilling with Recombinant Human Bone Morphogenetic Protein-2 in Korean Patients with Non-Traumatic Osteonecrosis of the Femoral Head: A Prospective Randomized Pilot Study with a Minimum Two-Year Follow-Up.

We sought to determine whether multiple drilling (MD) combined with the injection of recombinant human bone morphogenetic protein-2 (rhBMP-2) and ß-tricalcium phosphate (ß-TCP) could improve survival of the femoral head in pre-collapse lesions of non-traumatic osteonecrosis of the femoral head (ONFH) as compared with MD alone. We conducted a single-site, off-label, comparative and prospective cohort study between November 2017 and May 2019. We enrolled 25 hips (25 patients) with non-traumatic ONFH (Ficat-Arlet stage 2A or less). We performed a survival analysis, and the primary outcome was the occurrence of femoral head collapse on follow-up radiograph. Our cohort consisted of 11 men and 9 women of age 52.5 ± 8.8 years and a body mass index of 24.3 ± 3.0 kg/m2. The femoral heads were preserved in 9 hips (45.0%) and collapsed in 11 hips (55.0%) at the final follow-up; mean survival to collapse was 6.9 (range 2.8-13.5) months. There were no significant differences in the survival of the femoral head between the MD alone group and the MD with rhBMP-2 and ß-TCP group (five hips survived, 50% vs. four hips survived, 40%, respectively; p = 0.83). MD combined with the injection of rhBMP-2 and ß-TCP did not improve femoral head survival compared to MD alone in the pre-collapse non-traumatic ONFH lesion.

Knee Extension Is Related to the Posteriorly Deviated Gravity Line to the Pelvis in Young Adults: Radiographic Analysis Using Low-Dose Biplanar X-ray.

PURPOSE: We sought to compare the radiographic parameters concerning the sagittal alignment of the standing whole-body skeletons between the knee extension group and control group using the low-dose biplanar X-ray system in a young adult population without knee pain, and to investigate the associated variables for the sagittal knee angle (sagKA) among the radiographic parameters of global sagittal alignment. MATERIALS AND METHODS: We reviewed whole-body standing sagittal radiographs of 124 young adults taken from December 2018 to May 2020 in a single institution. We compared the radiographic parameters concerning the lower extremity sagittal alignment and global sagittal alignment between the knee extension group and control group. The factors correlated with sagKA were evaluated using multiple linear regression analysis. RESULTS: The sagittal vertical axis (SVA), the horizontal offset between the gravity line (GL) and the posterior edge of S1 endplate (GL-S), and the horizontal offset between the GL and the hip center (GL-H) were -11.6±21.3 mm, 5.1±23.8 mm, and -25.1±27.1 mm in the knee extension group, respectively, which were significantly smaller than those in the control group. The C7 plumb line (C7PL) and GL were deviated posterior to the sacrum and the hip center in the knee extension group, with the mean sagKA of -5.6° in young adults. CONCLUSION: The GL-H using GL, not the SVA using C7PL, was a significant radiographic factor associated with the sagKA.

Effectiveness of ERAS (Enhanced Recovery after Surgery) Protocol via Peripheral Nerve Block for Total Knee Arthroplasty.

Peripheral nerve block (PNB) for patients with total knee arthroplasty (TKA) is one of the recommended interventions in ERAS protocols. However, most existing studies involved unilateral TKA (UTKA). As such, this study aimed to evaluate the effectiveness of PNB in terms of immediate postoperative analgesia, length of hospital stays (LOS), and early functional outcomes in both UTKA and simultaneous bilateral TKAs (BTKAs). We reviewed 236 patients who underwent primary TKA with PNB, with 138 and 98 being UTKA and BTKAs, respectively; those in the PNB group underwent femoral nerve and adductor canal block. The matched control and PNB groups-who received intravenous/epidural patient-controlled analgesia (IVPCA/PCEA) alone or IVPCA in addition to PNB after surgery, respectively-were compared. The VAS scores at rest until 48 h after surgery were significantly lower in PNB groups compared to those in the IVPCA groups. At 0- 6 h of activity, VAS scores of the UTKA with PNB group were also lower than the IVPCA group. Compared to PCEA groups, VAS scores at 0-6 h of activity were higher in both the UTKA and BTKAs with PNB groups. However, at 24-48 h at rest, the scores of those in the UTKA with PNB group were lower than those in the PCEA group. The control and experimental UTKA and BTKAs groups had similar LOS and functional outcomes at 90 days postoperatively. In primary TKA, PNB has great analgesic effects for immediate postoperative pain control, and represents a similar analgesic effect to epidural PCA.

Safety and Efficacy of the Intra-articular Injection of Mesenchymal Stem Cells for the Treatment of Osteoarthritic Knee: A 5-Year Follow-up Study.

Although successful short-term results of the intra-articular injection of mesenchymal stem cells (MSCs) for the conservative treatment of knee osteoarthritis (OA) have been reported, the mid-term results of the injection of adipose-derived (AD) MSCs remains unknown. We assessed the mid-term safety and efficacy of the intra-articular injection of ADMSCs in patients with knee OA. Eleven patients with knee OA were prospectively enrolled and underwent serial evaluations during a 5-year follow-up of a single intra-articular injection of autologous high-dose (1.0 × 108) ADMSCs. The safety profiles were assessed using the World Health Organization Common Toxicity Criteria. The clinical evaluations included visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for pain and function, respectively. The radiologic evaluations included chondral defect area and whole-organ magnetic resonance imaging scores (WORMS) by serial magnetic resonance imaging (MRI). Hip-knee-ankle axis (HKAA) and Kellgren-Lawrence (K-L) grades were assessed on simple radiographs. No treatment-related adverse events occurred during the 5-year follow-up. Both VAS and total WOMAC scores improved significantly at 6 months after the injection and until the latest follow-up. Total WORMS was significantly improved until 3 years after the injection. However, the chondral defect size on MRI or other radiologic evaluations did not change significantly. A single intra-articular injection of autologous, high-dose ADMSCs provided safe and clinical improvement without radiologic aggravation for 5 years. Furthermore, structural changes in the osteoarthritic knee showed significant improvement up to 3 years, suggesting a possible option for disease-modifying outpatient treatment for patients with knee OA.

Biomechanical effect of anatomical tibial component design on load distribution of medial proximal tibial bone in total knee arthroplasty : finite element analysis indicating anatomical design prevents stress-shielding.

AIMS: This study aimed to identify the effect of anatomical tibial component (ATC) design on load distribution in the periprosthetic tibial bone of Koreans using finite element analysis (FEA). METHODS: 3D finite element models of 30 tibiae in Korean women were created. A symmetric tibial component (STC, NexGen LPS-Flex) and an ATC (Persona) were used in surgical simulation. We compared the FEA measurements (von Mises stress and principal strains) around the stem tip and in the medial half of the proximal tibial bone, as well as the distance from the distal stem tip to the shortest anteromedial cortical bone. Correlations between this distance and FEA measurements were then analyzed. RESULTS: The distance from the distal stem tip to the shortest cortical bone showed no statistically significant difference between implants. However, the peak von Mises stress around the distal stem tip was higher with STC than with ATC. In the medial half of the proximal tibial bone: 1) the mean von Mises stress, maximum principal strain, and minimum principal strain were higher with ATC; 2) ATC showed a positive correlation between the distance and mean von Mises stress; 3) ATC showed a negative correlation between the distance and mean minimum principal strain; and 4) STC showed no correlation between the distance and mean measurements. CONCLUSION: Implant design affects the load distribution on the periprosthetic tibial bone, and ATC can be more advantageous in preventing stress-shielding than STC. However, under certain circumstances with short distances, the advantage of ATC may be offset. Cite this article: Bone Joint Res 2022;11(5):252-259.

Difference between medial and lateral tibia plateau in the coronal plane: importance of preoperative evaluation for medial unicompartmental knee arthroplasty.

BACKGROUND: Setting bone cutting levels for different joint line orientations of the medial and lateral tibia plateaus in individual patients is not clear. We aimed to evaluate the difference between joint line orientation of the medial and lateral tibia plateaus relative to the horizontal line of mechanical axis of tibia as tibial plateau difference (TPD) for an optimal tibial bone cut in medial unicompartmental knee arthroplasty (UKA) and determine which factors could influence TPD. We aimed to investigate the effect of preoperative TPD on polyethylene liner size in medial UKA. METHODS: TPD in the coronal plane were measured in 181 female patients (181 knees). To determine the morphology of proximal tibia according to the severity of osteoarthritis, the patients were classified into three groups based on diagnosis and treatment: 80 who underwent robot-assisted medial UKA, 45 who underwent total knee arthroplasty (TKA), and 56 with early-stage osteoarthritis (OA) who had conservative management. Also, we divided the medial UKA group into two groups according to TPD (greater than or less than 5 mm) and compared polyethylene liner sizes. RESULTS: No significant difference was observed in TPD (p = 0.662), difference between the medial and lateral femoral condyle levels (p = 0.54), medial proximal tibial angle (p = 0.169), or posterior tibial slope (p = 0.466) among the three groups. Increased TPD was significantly associated with increased mechanical femorotibial angle(mFTA) (p < 0.01). The medial UKA group was divided into two groups according to TPD greater or less than 5 mm. Thicker polyethylene liners were used for groups with TPD greater than 5 mm (8.5 ± 0.7 mm versus 8.2 ± 0.3 mm, p = 0.01). Additionally, the proportion of patients using the thinnest polyethylene (8 mm) in each TPD group (greater or less than 5 mm) was higher in patients with TPD less than 5 mm (82.4% versus 58.7%, p = 0.038). CONCLUSIONS: Preoperative measurement of TPD is important to help surgeons predict the most appropriate bone cutting level in the coronal plane in primary medial UKA. Tibial bone resection would be likely to be thicker than needed in patients with increased TPD in medial UKA.

Acetabular labral tear is associated with high pelvic incidence with or without femoroacetabular impingement morphology.

PURPOSE: The aim of this study was to investigate the association between pelvic sagittal parameters and acetabular labral tears. METHODS: Three-hundred and sixty-five patients (449 hips) who underwent magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA) for hip pain were enrolled in this study. Pelvic sagittal parameters, including the pelvic incidence, pelvic tilt, and sacral slope, were measured with a standing lumbosacral lateral radiograph. All subjects were divided into two groups according to the presence or absence of radiologic acetabular labral tears and compared. Furthermore, the two groups were divided into subgroups according to whether femoroacetabular impingement (FAI) morphology was present or not and compared. RESULTS: Pelvic incidence was greater in the labral tear group than in the non-labral tear group (52.3° ± 8.2° versus 47.1° ± 6.8°, p < 0.001). After accounting for potentially confounding variables, we found that higher age (odds ratio 1.04, 95% confidence interval [CI] 1.02 to 1.06, p = 0.001), FAI (odds ratio 15.11, 95% CI 7.43 to 30.75, p < 0.001), and high pelvic incidence (odds ratio 1.13, 95% CI 1.09 to 1.17, p < 0.001) were independently associated with acetabular labral tear. When only the patients without FAI (308 hips) were divided into groups with and without acetabular labral tear, we found that higher age (odds ratio 1.03, 95% CI 1.01 to 1.06, p = 0.008) and high pelvic incidence (odds ratio 1.15, 95% CI 1.11 to 1.19, p < 0.001) were independently associated with acetabular labral tear. CONCLUSION: Acetabular labral tear is associated with high pelvic incidence with or without FAI morphology. LEVEL OF EVIDENCE: III.

Method Categorization of Stem Cell Therapy for Degenerative Osteoarthritis of the Knee: A Review.

Current clinical applications of mesenchymal stem cell therapy for osteoarthritis lack consistency because there are no established criteria for clinical processes. We aimed to systematically organize stem cell treatment methods by reviewing the literature. The treatment methods used in 27 clinical trials were examined and reviewed. The clinical processes were separated into seven categories: cell donor, cell source, cell preparation, delivery methods, lesion preparation, concomitant procedures, and evaluation. Stem cell donors were sub-classified as autologous and allogeneic, and stem cell sources included bone marrow, adipose tissue, peripheral blood, synovium, placenta, and umbilical cord. Mesenchymal stem cells can be prepared by the expansion or isolation process and attached directly to cartilage defects using matrices or injected into joints under arthroscopic observation. The lesion preparation category can be divided into three subcategories: chondroplasty, microfracture, and subchondral drilling. The concomitant procedure category describes adjuvant surgery, such as high tibial osteotomy. Classification codes were assigned for each subcategory to provide a useful and convenient method for organizing documents associated with stem cell treatment. This classification system will help researchers choose more unified treatment methods, which will facilitate the efficient comparison and verification of future clinical outcomes of stem cell therapy for osteoarthritis.

Intra-Articular Injection of a Novel DVS Cross-Linked Hyaluronic Acid Manufactured by Biological Fermentation (YYD302) in Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Multicenter, Noninferiority Study.

PURPOSE: This double-blind, randomized, Phase III clinical trial was conducted to assess the efficacy and safety of the novel divinyl sulfone cross-linked hyaluronate (YYD302) compared with the 1,4-butanediol diglycidyl ether cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis. METHODS: A total of 184 patients with osteoarthritis (Kellgren-Lawrence grade I-III) were randomized to 1 of 2 study groups (YYD302 group, n = 95; Synovian group, n = 89). A single injection of YYD302 or Synovian was given to both groups, and 182 participants completed the study (YYD302 group, n = 95; Synovian group, n = 87). The primary end point was the change in weight-bearing pain (WBP) at 12 weeks after the primary single injection. Secondary end points included the Knee Injury and Osteoarthritis Outcome Score; the Western Ontario and McMaster Universities Osteoarthritis Index score; the Patient Global Assessment and Investigator Global Assessment; the range of motion, swelling, and tenderness of the target knee; OMERACT-OARSI responder rate; WBP responder rate (the proportion of patients achieving at least 20 mm or 40% decrease in WBP); and rate of rescue medicine use and its total consumption at weeks 2, 4, and 12. Based on the efficacy results at week 12, the responders were administered an additional single injection of the same study drug at week 24, and safety and efficacy were additionally assessed at week 36. FINDINGS: Mean changes of WBP at 12 weeks after the primary injection were -31.76 mm with YYD302 and -29.74 mm with Synovian, proving noninferiority of the YYD302 group to the Synovian group as the lower bound of the 95% CI (-4.3 to 8.3) was well above the predefined margin (-10 mm). At week 2, the Knee Injury and Osteoarthritis Outcome Score (total, pain, activities of daily living, and sports/recreation) and Western Ontario and McMaster Universities Osteoarthritis Index scores (total, stiffness) were significantly better in the YYD302 group than in the Synovian group. There were no significant differences between the groups in all other end points. Local overall adverse events (pain, heat, erythema, or swelling) at the injection site were observed in 48.4% of the YYD302 group and in 47.7% of the Synovian group. No serious reactions were reported. There was no statistically significant difference between the 2 groups regarding re-injected patients (YYD302 group, n = 54; Synovian group, n = 46) in any of the efficacy outcomes at week 36. IMPLICATIONS: The results of this study support that YYD302 is comparable to Synovian in terms of the efficacy and safety of the intra-articular injection treatment for osteoarthritis of the knee joint. Furthermore, YYD302 provided faster improvements in some efficacy assessments compared with Synovian. ClinicalTrials.gov identifier: NCT03561779.

Quantitative proteomic analysis comparing grades ICRS1 and ICRS3 in patients with osteoarthritis.

Osteoarthritis (OA), which is caused by joint damage, is the most common form of arthritis, affecting millions of people worldwide. This damage can accumulate over time, which is why aging is one of the main contributors to joint damage associated with OA. The OA-related proteins that have been reported to date have been identified by the comparative analysis of OA patients with normal controls, following surgical or pharmacological treatment. For the first time, the present study analyzed OA-related proteins in patients with OA according to the International Cartilage Repair Society (ICRS) scale. Changes in protein expression can be observed during the OA process. The present study demonstrated differential protein expression patterns in articular cartilage from ICRS1- and ICRS3-graded OA patients. ICRS grade-matched OA knee samples from 12 OA patients, 6 ICRS grade 1 patients and 6 ICRS3 patients were subjected to proteomic analysis using the LTQ-Orbitrap mass spectrometry system. A total of 231 unique proteins were identified as expressed across the ICRS1 and ICRS3 OA patient groups. Relative differences in protein expression associated with the following classifications were observed: Biological adhesion, cell killing, cellular process, development process and molecular function. Although some of these proteins have been previously reported to be associated with rheumatoid arthritis, including cartilage oligomeric matrix protein, collagen types, angiogenin, complement C5 and CD59 glycoprotein, numerous additional proteins were newly identified, which may further help our understanding of disease pathogenesis. These findings suggested that these proteins may be used to develop novel therapeutic targets for OA.

Cross-Sectional Association between Hypercholesterolemia and Knee Pain in the Elderly with Radiographic Knee Osteoarthritis: Data from the Korean National Health and Nutritional Examination Survey.

Few studies have reported the relationship between knee pain and hypercholesterolemia in the elderly population with osteoarthritis (OA), independent of other variables. The aim of this study was to reveal the association between knee pain and metabolic diseases including hypercholesterolemia using a large-scale cohort. A cross-sectional study was conducted using data from the Korea National Health and the Nutrition Examination Survey (KNHANES-V, VI-1; 2010-2013). Among the subjects aged ≥60 years, 7438 subjects (weighted number estimate = 35,524,307) who replied knee pain item and performed the simple radiographs of knee were enrolled. Using multivariable ordinal logistic regression analysis, variables affecting knee pain were identified, and the odds ratio (OR) was calculated. Of the 35,524,307 subjects, 10,630,836 (29.9%) subjects experienced knee pain. Overall, 20,290,421 subjects (56.3%) had radiographic OA, and 8,119,372 (40.0%) of them complained of knee pain. Multivariable ordinal logistic regression analysis showed that among the metabolic diseases, only hypercholesterolemia was positively correlated with knee pain in the OA group (OR 1.24; 95% Confidence Interval 1.02-1.52, p = 0.033). There were no metabolic diseases correlated with knee pain in the non-OA group. This large-scale study revealed that in the elderly, hypercholesterolemia was positively associated with knee pain independent of body mass index and other metabolic diseases in the OA group, but not in the non-OA group. These results will help in understanding the nature of arthritic pain, and may support the need for exploring the longitudinal associations.

Enhancing the efficiency of solution-processed inverted quantum dot light-emitting diodes via ligand modification with 6-mercaptohexanol.

In this Letter, the surface hydrophilicity of the quantum dot (QD) emitting layer (EML) was modified via a ligand exchange to prevent QD EML damage upon hole transport layer (HTL) deposition for all-solution-processed inverted QD-light-emitting diodes (QLEDs). The conventional hydrophobic oleic acid ligand (OA-QDs) was partially replaced with a hydrophilic 6-mercaptohexanol (OH-QDs) through a one-pot ligand exchange. Owing to this replacement, the contact angle of a water droplet on the OH-QD films was reduced to 71.7° from 89.5° on the OA-QD films, indicating the conversion to hydrophilic hydroxyl ligands. The OH-QD EML maintained its integrity without any noticeable damage, even after HTL deposition, enabling all-solution processing for inverted QLEDs with well-organized multilayers. Inverted QLEDs with the OH-QD EMLs were compared with those with OA-QD EMLs; the maximum current efficiency of the device with the OH-QD EML significantly improved to 39.0 cd A-1 from 5.3 cd A-1, and the peak external quantum efficiency improved to 9.3% from 1.2%, which is a seven-fold increase over the OA-QD device. This approach is believed to be effective for forming solid QD films with resistance to chlorobenzene, a representative HTL solvent, and consequently contributes to high-efficiency all-solution-processed inverted QLEDs.

The effect of hamstring tightness on intraoperative extension gap in posterior stabilized total knee arthroplasty.

This study aimed to determine the factors related to intraoperative extension gap (EG) in patients who underwent posterior-stabilized total knee arthroplasty (TKA). A total of 106 TKAs in 84 patients were retrospectively reviewed. Only patients who underwent the same method of bone resection were included consecutively. Bilateral popliteal angle (BPA) was used as an indicator of hamstring tightness. EG and extension space angle were measured using an offset type tensor. The associations between patient variables and EG were analyzed using multivariable linear regression and Pearson's correlation coefficients. The average EG was 12.9 ± 2.1 mm, and the average extension space angle was 2.8° ± 3.2°. BPA was greater than flexion contracture in most cases (94.3%), and no difference was found in only six cases (5.7%). According to multivariable linear regression analysis which was conducted after modifying the BPA into a categorical variable by 5°, EG was correlated with BPA (p < 0.001). Pearson's correlation coefficient between EG and BPA was - 0.674 (p < 0.001). No other factors were significantly correlated with intraoperative EG. The present study found that popliteal angle is a different entity from flexion contracture, and that it is a predictable factor for EG in osteoarthritis patients. Smaller BPAs led to larger EG in patients who underwent the same degree of bone resection.

Anatomical tibial component is related to more medial tibial stress shielding after total knee arthroplasty in Korean patients.

PURPOSE: This study aimed to investigate stress shielding of anatomical tibial components (ATCs) in comparison to conventional symmetric tibial components (STCs) in Korean patients which may be related to medial tibial bone loss. METHOD: 78 knees in 59 patients with ATCs (Persona™) and 74 knees in 58 patients with STCs (NexGen LPS-Flex™) were retrospectively reviewed. Radiographic parameters and clinical outcomes in both groups were compared. Logistic regression analysis was performed to identify risk factors for medial tibial bone loss. RESULTS: Medial tibial bone loss was significantly greater in the ATC group (1.6 ± 1.3 mm) than in the STC group (0.4 ± 0.8 mm) (p < 0.001). The ATC group showed a shorter distance between the distal metal tip and anteromedial cortex and higher invading into the sclerotic bone lesion (ISBL) than the STC group (p = 0.034 and p = 0.044, respectively). Multiple logistic regression analysis suggested ATC, a shorter distance to the anteromedial cortex, and the presence of ISBL as risk factors for medial tibial bone loss. The odds ratios of medial tibial bone loss according to type of prosthesis, distance to anteromedial cortex, and presence of ISBL were 6.25 (range 2.86-13.63, p < 0.001), 0.69 (range 0.51-0.93, p = 0.015), and 3.79 (range 1.56-9.21, p = 0.003), respectively. Notwithstanding, there was no difference in clinical outcomes between the two groups. CONCLUSION: In Korean patients, ATCs potentially causes greater medial tibial bone loss due to stress shielding than STCs. The design, however, does not yet appear to affect clinical outcomes at mid-term follow-up. LEVEL OF EVIDENCE: Retrospective cohort study, level III.