Safety and Effectiveness of Robotic-Arm Assisted Total Knee Arthroplasty.

OBJECTIVE: We investigated the advantages of robotic arm-assisted total knee arthroplasty (raTKA) over conventional manual TKA (cmTKA) by comprehensively comparing patients who received raTKA and cmTKA in terms of postoperative pain, function, imaging assessment, and trauma to the body. This study investigated the efficacy and safety of raTKA in patients using the YUANHUA-TKA system. METHODS: In a prospective, randomized single-blind trial, 60 patients undergoing primary unilateral TKA from October 2020 to December 2020 were randomly assigned to either raTKA or cmTKA. Clinical evaluation, including the time of osteotomy and prosthesis model testing, the total operation time, the visual analogue scale at rest, VAS in motion, opioid consumption, white blood cell count, neutrophil ratio, erythrocyte sedimentation rate, C-reactive protein (CRP), passive and active range of motion (pROM, aROM), Western Ontario and McMaster Universities Arthritis Index (WOMAC [stiffness, pain, and function]) score, gait analysis, keen society score (KSS), adverse events, and blood loss were collected by the project nurse, as well as the imaging evaluation, including the lateral tibia component angle (LTC), frontal femoral component angle, frontal tibia component angle (FTC), lateral femoral component angl, and hip-knee-ankle angle (HKA). The student t-test (or the Wilcoxon signed-rank test) and the χ2-test (or the Fisher exact test) were used to determine differences in categorical variables. RESULTS: No significant difference was found between the two groups in pain throughout the whole follow-up period. On the third day postoperatively, the erythrocyte sedimentation rate in the cmTKA group was significantly higher (p = 0.02), as well as the CRP (p = 0.04). No significant difference was found in the WOMAC stiffnes score or pROM. However, the aROM and the flexion range when walking (FRW) were significantly better in the raTKA group throughout the trial (p < 0.05). The KSS at the 1-month follow-up and the WOMAC function score at the 1-year follow-up were both significantly better in the raTKA group (p < 0.05). The HKA and the LTC in the raTKA group closer to the ideal angle, and the difference between the groups was significant (p < 0.05). The total operation time of the raTKA group was significantly longer (p = 0.001). The intraoperative blood loss had no significant difference in the two groups. CONCLUSION: Compared with cmTKA, raTKA with the YUANHUA robot not only avoids extra pain and trauma in patients but promises better functional recovery and improves the accuracy of the prosthesis position and axial alignment reconstruction.

Ultrasound-Activated Probiotics Vesicles Coating for Titanium Implant Infections Through Bacterial Cuproptosis-Like Death and Immunoregulation.

Implant-associated infections (IAIs) are the main cause of prosthetic implant failure. Bacterial biofilms prevent antibiotic penetration, and the unique metabolic conditions in hypoxic biofilm microenvironment may limit the efficacy of conventional antibiotic treatment. Escaping survival bacteria may not be continually eradicated, resulting in the recurrence of IAIs. Herein, a sonosensitive metal-organic framework of Cu-TCPP (tetrakis(4-carboxyphenyl) porphyrin) nanosheets and tinidazole doped probiotic-derived membrane vesicles (OMVs) with high-penetration sonodynamic therapy (SDT), bacterial metabolic state interference, and bacterial cuproptosis-like death to eradicate IAIs is proposed. The Cu-TCPP can convert O2 to toxic 1O2 through SDT in the normoxic conditions, enhancing the hypoxic microenvironment and activating the antibacterial activity of tinidazole. The released Cu(II) under ultrasound can be converted to Cu(I) by exogenous poly(tannic acid) (pTA) and endogenous glutathione. The disruption of the bacterial membrane by SDT can enhance the Cu(I) transporter activity. Transcriptomics indicate that the SDT-enhanced Cu(I) overload and hypoxia-activated therapy hinder the tricarboxylic acid cycle (TCA), leading to bacterial cuproptosis-like death. Moreover, the OMVs-activated therapy can polarize macrophages to a M2-like phenotype and facilitate bone repair. The sonodynamic biofilm microenvironment modulation strategy, whereby the hypoxia-enhanced microenvironment is potentiated to synergize SDT with OMVs-activated therapy, provides an effective strategy for antibacterial and osteogenesis performance.

Ultrasound-activated piezo-hot carriers trigger tandem catalysis coordinating cuproptosis-like bacterial death against implant infections.

Implant-associated infections due to the formation of bacterial biofilms pose a serious threat in medical healthcare, which needs effective therapeutic methods. Here, we propose a multifunctional nanoreactor by spatiotemporal ultrasound-driven tandem catalysis to amplify the efficacy of sonodynamic and chemodynamic therapy. By combining piezoelectric barium titanate with polydopamine and copper, the ultrasound-activated piezo-hot carriers transfer easily to copper by polydopamine. It boosts reactive oxygen species production by piezoelectrics, and facilitates the interconversion between Cu2+ and Cu+ to promote hydroxyl radical generation via Cu+ -catalyzed chemodynamic reactions. Finally, the elevated reactive oxygen species cause bacterial membrane structure loosening and DNA damage. Transcriptomics and metabolomics analysis reveal that intracellular copper overload restricts the tricarboxylic acid cycle, promoting bacterial cuproptosis-like death. Therefore, the polyetherketoneketone scaffold engineered with the designed nanoreactor shows excellent antibacterial performance with ultrasound stimulation and promotes angiogenesis and osteogenesis on-demand in vivo.

A commentary on 'Clinical evaluation of the first semi-active total knee arthroplasty assisting robot made in China: a retrospective propensity score-matched cohort study'.

We were highly interested in the article entitled 'Clinical evaluation of the first semi-active total knee arthroplasty assisting robot made in China: a retrospective propensity score-matched cohort study' by Yang et al. The authors aim to conduct the postoperative prosthesis position and clinical functions of the semi-active total knee arthroplasty assisting robot (RATKA) using a 1:2 propensity score matching. However, we came across what we believed were flaws in the study methodology and results about the prothesis and tourniquet, and we would like to discuss them with the authors in conjunction with our own research.

Combination of C-reactive protein and fibrinogen is useful for diagnosing periprosthetic joint infection in patients with inflammatory diseases.

BACKGROUND: The screening of periprosthetic joint infection (PJI) in patients with inflammatory diseases before revision arthroplasty remains uncertain. Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), plasma fibrinogen (FIB), monocyte/lymphocyte ratio, and neutrophil/lymphocyte ratio (NLR) can help screening PJI, but their values in patients with inflammatory diseases have not been determined. METHODS: Patients with inflammatory diseases who underwent revision hip or knee arthroplasty at West China Hospital, Sichuan University, from January 2008 to September 2020 were divided into infected and non-infected groups based on the 2013 International Consensus Meeting criteria. Sensitivity and specificity of the tested biomarkers for diagnosing infection were determined based on receiver operating characteristic (ROC) curves, and optimal cutoffs were determined based on the Youden index. The diagnostic ability of these biomarkers was re-assessed after combining them with each other. RESULTS: A total of 62 patients with inflammatory diseases were studied; of them 30 were infected. The area under the ROC curve was 0.813 for CRP, 0.638 for ESR, 0.795 for FIB, and 0.656 for NLR. The optimal predictive cutoff of CRP was 14.04 mg/L with a sensitivity of 86.2% and a specificity of 68.7%, while FIB had a sensitivity of 72.4% and a specificity of 81.2% with the optimal predictive cutoff of 4.04 g/L. The combinations of CRP with FIB produced a sensitivity of 86.2% and specificity of 78.1%. CONCLUSION: CRP with a slightly higher predictive cutoff and FIB are useful for screening PJI in patients with inflammatory diseases, and the combination of CRP and FIB may further improve the diagnostic values. TRIAL REGISTRATION: ChiCTR.org.cn, ChiCTR2000039989.

Effect of tourniquet use on blood loss, pain, functional recovery, and complications in robot-assisted total knee arthroplasty: a prospective, double-blinded, randomized controlled trial.

BACKGROUND: Robot-assisted total knee arthroplasty (TKA) has been largely studied to confirm its advantages in terms of accurate component positioning, microembolus formation, less blood loss, and so on, but is currently usually performed under tourniquet due to its longer operative time than conventional TKA. The aim of this study was to estimate the effects of tourniquet use in robot-assisted TKA on blood loss, pain, functional recovery, and complications. METHODS: Patients scheduled for robot-assisted TKA were prospectively randomized into a tourniquet or non-tourniquet group (each n = 14). The primary outcome measure was blood loss. The secondary outcome measures were operation time; visual analog scale (VAS) pain scores; time to achieve the first straight-leg raise; swelling of the thigh, knee, and calf; range of motion; Hospital for Special Surgery score; length of stay; and postoperative complications. RESULTS: There was no significant difference in total blood loss between the tourniquet and non-tourniquet groups (738.57 ± 276.158 vs. 866.85 ± 243.422 ml, P = 0.061). The tourniquet group showed significantly lower intraoperative blood loss (P < 0.001), but higher hidden blood loss (P = 0.002). The non-tourniquet group showed better knee range of motion on postoperative days (PODs) 1-3 (all P < 0.001), less thigh swelling on PODs 2 and 3 (P < 0.05), earlier straight-leg raising (P = 0.044), and shorter length of stay (P = 0.044). Thigh pain VAS score at 1 month after surgery was significantly greater in the tourniquet group (P < 0.001), as was knee pain during activity and at rest on PODs 2-3 (all P < 0.05). The tourniquet group also showed a significantly higher rate of tension blisters (28.8% vs. 7.1%, P = 0.038). CONCLUSIONS: Tourniquet use during robot-assisted TKA does not reduce total blood loss, and it appears to increase postoperative pain, aggravate muscle injury, and prolong postoperative recovery. Trial registration ChiCTR, ChiCTR2100041800. Registered 5 January 2021, http://www.chictr.org.cn/index.aspx .

The use of cell salvage during second-stage reimplantation for the treatment of chronic hip periprosthetic joint infection: a retrospective cohort study.

INTRODUCTION: Given the possibility of inadvertent bacterial contamination of salvaged blood, the use of cell salvage is relatively contraindicated in cases of reimplantation for chronic hip periprosthetic joint infection (PJI). However, there are no published data supporting this assertion. The purpose of the current study was to compare the reinfection rate and rate of postoperative allogeneic blood transfusion (ABT) in second-stage reimplantation for PJI with or without intraoperative cell salvage reinfusion. MATERIALS AND METHODS: We identified 125 patients who underwent two-stage exchange for chronic hip PJI between November 2012 and April 2019. The groups of patients who had (n = 61) and had not (n = 64) received intraoperative cell salvage reinfusion were compared with respect to the curative infection-free rate. Moreover, we compared the need for postoperative ABT and identified independent factors associated with ABT using multiple regression analysis. RESULTS: The log-rank survival curve with an endpoint of infection eradication failure was not significantly different between the cell salvage group (98.4%, 95% CI 95.3-99.9%) and the control group (95.3%, 95% CI 90.2-99.9%) at one year (log rank, P = .330). The rates of postoperative ABT in the cell salvage group were significantly lower than those in the control group (11.5% vs 26.6%, P = .041). In multivariable models, patient age, body mass index, preoperative hemoglobin level, and intraoperative cell salvage were independent predictors of ABT exposure (P < .05). CONCLUSIONS: The use of cell salvage during reimplantation in two-stage exchange for chronic hip PJI did not appear to increase the reinfection rate, while it significantly reduced the rate of postoperative allogeneic red blood transfusion. Greater age, lower BMI, lower preoperative hemoglobin, and non-intraoperative cell salvage reinfusion were associated with higher rate of allogeneic red blood transfusion.

Comparison of Outcomes After Total Knee Arthroplasty Involving Postoperative Neutral or Residual Mild Varus Alignment: A Systematic Review and Meta-analysis.

Comparing mainly clinical and functional outcomes as well as prosthesis survival with neutral and residual mild varus alignment, we searched PubMed, Embase, Cochrane Library and Web of Science databases from 1 January 1974 to 18 December 2020 to identify studies comparing clinical and functional outcomes as well as prosthesis survival in the presence of different alignments after total knee arthroplasty (TKA) for varus knees. The included studies were assessed by two researchers according to the Newcastle-Ottawa Scale (NOS). Postoperative neutral alignment (0° ± 3°) was compared to residual mild varus (3°-6°) and residual severe varus (>6°). Meta-analysis was performed using Review Manager 5.3. The odds ratios (OR) and mean differences (MD) were used to compare dichotomous and continuous variables. The fixed-effect model and random-effect model were used to meta-analyze the data. Nine studies were included in the meta-analysis with 1410 cases of postoperative neutral alignment, 564 of residual mild varus alignment and 175 of residual severe varus alignment following TKA, all of which were published after 2013. Three studies scored 7 points on the NOS, while the remaining studies scored 8 points, suggesting high quality. The pooled mean differences (MDs) of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score were 1.07 [95% confidence interval (CI) -1.06 to 3.20; P = 0.32; I2 = 79%]. The meta-analysis showed that neutral alignment and mild varus alignment were associated with similar the Oxford Knee Score (OKS), Knee Society Knee Score (KS-KS), and Knee Society Function Score (KS-FS), while neutral alignment was associated with lower Forgotten Joint Score (FJS) [mean difference -6.0, 95% confidence interval (CI) -9.37 to -2.64, P = 0.0005]. Neutral alignment was associated with higher KS-KS than severe alignment (M 2.98, 95% CI 1.42 to 4.55, P = 0.0002; I2 = 0%) as well as higher KS-FS (M 8.20, 95% CI 4.58 to 11.82, P < 0.00001; I2 = 0%). Neutral alignment was associated with similar rate of survival as mild varus alignment (95% CI 0.36 to 9.10; P = 0.48; I2 = 65%) or severe varus alignment (95% CI 0.94 to 37.90; P = 0.06; I2 = 61%). There was no statistical difference in others. Residual mild varus alignment after TKA may lead to similar or superior outcomes than neutral alignment in patients with preoperative varus knees, yet the available evidence appears to be insufficient to replace the current gold standard of neutral alignment. Severe varus alignment should be avoided.

[A prospective randomized controlled trial on the short-term effectiveness of domestic robot-assisted total knee arthroplasty].

OBJECTIVE: To explore the short-term effectiveness of domestic robot-assisted total knee arthroplasty (RATKA) conducted by a prospective randomized controlled trial. METHODS: Patients who were scheduled for primary unilateral TKA between October 2020 and December 2020 were eligible in this randomized controlled trial. According to the random number table method, they were allocated to the traditional TKA group and the RATKA group [application of the Yuanhua robotic-assisted TKA (YUANHUA-TKA) system during operation]. A total of 63 patients met the selection criteria were enrolled in the study, of which 3 cases voluntarily withdrew from the trial. And finally 60 cases were enrolled for analysis; of which 28 cases were in the RATKA group and 32 cases were in the traditional TKA group. There was no significant difference in gender, age, body mass index, American Society of Anesthesiologists (ASA) classification, duration of osteoarthritis, surgical side, and preoperative knee visual analogue scale (VAS) resting and motion scores, joint range of motion (ROM), Knee Society Score (KSS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain, stiffness, and function scores, hip-knee-ankle angle (HKA) deviation ( P>0.05). The operation time and intraoperative blood loss of the two groups were recorded. Knee joint VAS resting and motion scores, ROM, KSS scores, and WOMAC pain, stiffness, and function scores were used to evaluate the knee joint function and pain. Gait analysis (flexion and extension angle) was conducted at 3 months after operation. The full length X-ray films of lower limbs and anteroposterior and lateral X-ray films of knee joint were taken. The HKA deviation, lateral tibia component (LTC), frontal femoral component (FFC), frontal tibia component (FTC), and lateral femoral component (LFC) measured on the X-ray films were used to evaluat the lower limb alignment and prosthesis position. RESULTS: The operations of the two groups completed successfully; the incisions healed by first intention after operation, and no complications related to the operation occurred. The operation time of the RATKA group was significantly longer than that of the traditional TKA group ( t=12.253, P=0.001), and there was no significant difference in intraoperative blood loss between the two groups ( t=3.382, P=0.071). All patients were followed up 3 months. At 3 months after operation, the knee joint VAS resting and motion scores, ROM, KSS scores, and WOMAC pain, stiffness, and function scores improved significantly when compared with preoperatively in the two groups ( P<0.05); there was no significant difference of pre- and post-operative indicators between the two groups ( P>0.05). The gait analysis showed that the flexion and extension angle in the RATKA group was significantly bigger than that in the traditional TKA group ( t=9.469, P=0.003). X-ray films reexamination at 3 months after operation showed that the prostheses in the two groups were in good positions, and there was no adverse events such as prosthesis loosening or sinking. There were significant differences in the HKA deviation between pre- and post-operation in the two groups ( P<0.05), but the difference of pre- and post-operative HKA deviation between the two groups was not significant ( t=1.254, P=0.267). There was no significant difference in FFC, FTC, and LFC between the two groups ( P>0.05); the LTC was significantly smaller in the RATKA group than in the traditional TKA group ( t=17.819, P=0.000), which was closer to the ideal value. CONCLUSION: YUANHUA-TKA system can improve the accuracy of osteotomy and the prosthesis placement as well as the lower limb alignment. Its short-term effectiveness can be promised, but long-term effectiveness needs to be further studied.

Robotic arm-assisted total knee arthroplasty improves preoperative planning and intraoperative decision-making.

BACKGROUND: The reliability of robotic arm-assisted total knee arthroplasty (RA-TKA) has been previously reported. In this study, we evaluated the predictive accuracy of the RA-TKA system in determining the required bone resection and implant size preoperatively and its effect on intraoperative decision-making. METHODS: Data on the outcomes of RA-TKA procedures performed in our department were prospectively collected. A three-dimensional model of the femur, tibia, and fibula was reconstructed using standard computed tomography (CT) images. The model was used preoperatively to predict bone required resection for the femur and tibia and implant size. Intraoperatively, the images were registered to the local anatomy to create a patient-specific model for decision-making, including real-time measurement of the medial-to-lateral difference in the extension/flexion gap and TKA component alignment. Differences between predicted and real bone resections and implant size were evaluated, and the post-TKA mechanical axis of the lower limb and difference in medial-to-lateral flexion/extension gap were measured. RESULTS: The analysis was based on the data of 28 patients who underwent TKA to treat severe osteoarthritis. The RA-TKA system successfully predicted the femoral and tibial component within one implant size in 28/28 cases (100%). For the 168 bone resections performed, including both femoral and tibial cuts, the resection was within 1 mm of the predicted value in 120/168 (71%) of the cuts. The actual versus predicted bone resection was statistically different only for the lateral tibial plateau (p = 0.018). The medial-to-lateral gap difference was between - 1 and 1 mm, except in one case. The achieved lower limb alignment was accurate overall, with the alignment being within < 1.0° of the neutral mechanical axis in 13/28 cases (46%) and within < 3.0° in 28/28 cases (100%). CONCLUSIONS: The RA-TKA system provided considerable pre- and intraoperative surgical assistance to achieve accurate bone resection, appropriate component sizing, and postoperative alignment after RA-TKA.