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Effect of bone marrow aspiration concentrate and platelet-rich plasma combination in anterior cruciate ligament reconstruction: a randomized, prospective, double-blinded study
Lin, Y. C., Chen, Y. J., Fan, T. Y., Chou, P. H., Lu, C. C.
Journal of orthopaedic surgery and research. 2024;19(1):4
Abstract
BACKGROUND The effect of bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) combination in enhancing graft maturation and tendon-bone tunnel interfacial healing after anterior cruciate ligament (ACL) reconstruction remains unclear. We hypothesised that BMAC and PRP combination could lead to better clinical results and better graft maturation/interface healing than PRP alone or conventional ACL reconstruction without any other biologic augmentation. METHODS In this randomised double-blind prospective study, patients undergoing ACL reconstruction surgery were randomly assigned into three groups: (1) control group (without any biologic augmentation), (2) PRP treatment group, and (3) combined BMAC and PRP (BMAC + PRP) group. Moreover, they were evaluated using the clinical functional score, laxity examination, and magnetic resonance imaging (MRI) analysis. RESULTS No significant difference was observed in the improvement of functional scores among groups. However, laxity improvement at 24 weeks showed a significant difference with the BMAC + PRP group having the lowest laxity. MRI analysis showed no significant change in whole graft maturation among groups. In particular, the BMAC + PRP group showed delayed signal peak and higher graft signal at 24 weeks compared with the other two groups; however, the difference was not significant. With regard to tendon-bone interfacial healing, the BMAC + PRP group showed significantly wider tendon-bone interface in the femoral bone tunnel at 24 weeks compared with the other two groups. Moreover, the BMAC + PRP group showed significantly higher peri-tunnel edema signal in the femoral bone tunnel at 12 weeks compared with the other two groups. CONCLUSION PRP alone and BMAC and PRP combination showed limited enhancing effect in clinical function, graft maturation and tendon-bone interfacial healing compared with control (no additional treatment). When BMAC is used in ACL reconstruction, the possibility of greater inflammation in the early stage to graft maturation and bone tunnel healing should be considered.
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Impact of intraosseous regional administration of tranexamic acid in total knee arthroplasty on perioperative blood loss: a protocol for a randomised controlled trial
Wei, Z., Yu, M., Xu, Y., Weng, X., Feng, B.
BMJ open. 2024;14(2):e077393
Abstract
INTRODUCTION Total knee arthroplasty (TKA) is a common surgical intervention to treat joint diseases. However, TKA is associated with significant blood loss. Tranexamic acid (TXA) has been used to reduce perioperative bleeding and postoperative blood transfusion. This study aims to explore the effectiveness and safety of intraosseous regional administration (IORA) of TXA in TKA and compare differences in perioperative blood loss between IORA of TXA, intravenous infusion of TXA, and combined IORA and intravenous infusion of TXA. METHODS AND ANALYSIS This randomised controlled trial will enrol 105 patients with osteoarthritis who meet the inclusion criteria for unilateral TKA. Patients were randomly divided into three groups using the random number table method. Group A received 1.0 g of TXA via IORA, group B received 1.0 g of TXA via intravenous infusion 15 min prior to the tourniquet release, and group C received both IORA of 1.0 g of TXA and intravenous infusion of 1.0 g of TXA. The primary outcome measure is perioperative total blood loss. Secondary outcomes include bleeding events, venous thromboembolism events, inflammation reactions, other complications and knee function assessments. ETHICS AND DISSEMINATION This study has been approved by the Ethics Committee of Peking Union Medical College Hospital and registered in the Chinese Clinical Trial Registry. Informed consent will be obtained from all the patients before enrolment. The trial will be conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The results of this study will be disseminated through peer-reviewed publications, conference presentations and social media platforms. The findings will provide valuable insights into the use of IORA of TXA in TKA and may lead to the development of new strategies for perioperative blood management in joint replacement surgery. TRIAL REGISTRATION NUMBER The Ethics Committee of Peking Union Medical College Hospital (approval number: K2371); Chinese Clinical Trial Registry (trial registration number: ChiCTR2200066293).
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High dose of tranexamic acid infusion in primary total knee arthroplasty: A randomized multicenter clinical trail
Xie, J., Huang, Q., Huang, Z., Wang, F., Liu, J., Tian, H., Huang, W., Pei, F.
Chinese medical journal. 2024
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[Efficacy and safety of multiple-dose intravenous tranexamic acid for reducing blood loss in complex tibial plateau fractures: A prospective randomized controlled trial]
Bao, W., Zhou, J., Wang, Y., Wang, J., Chu, M.
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. 2023;37(9):1055-1061
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Abstract
OBJECTIVE To investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial. METHODS A study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference ( P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion. RESULTS ① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups ( P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant ( P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant ( P>0.05). There was no significant difference in the operation time between groups ( P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups ( P<0.05); there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant ( P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups ( P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups ( P>0.05), while there was a significant difference in IL-6 between groups ( P<0.05). CONCLUSION Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
PICO Summary
Population
Patients with Schatzker type IV – VI tibial plateau fractures (n= 88).
Intervention
Single dose of tranexamic acid (TXA) intravenous infusion, (n= 31).
Comparison
Multiple dose of intravenous TXA (n= 29); normal saline (control group), (n= 28).
Outcome
TXA efficacy evaluation: The lowest haemoglobin (Hb) value in the control group was significantly lower than that in the other two groups, and there was no significant difference between the single and multiple dose TXA groups. The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. TXA safety evaluation: No lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation. There was no significant difference in the operation time between groups. But the length of hospital stay was significantly longer in the control group than in the other groups. Effect of TXA on blood coagulation and inflammatory response: The incisions of the 3 groups healed by first intention, and no infections occurred.
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Comparison of Combined Intraarticular and Intravenous Administration of Tranexamic Acid with Intraarticular and Intravenous Alone in Patients Undergoing Total Knee Arthroplasty without Drainage Catheter: A Clinical Trial Study
Bagheri, N., Amini, M. A., Pourahmad, A., Vosoughi, F., Moharrami, A., Mortazavi, S. J.
The archives of bone and joint surgery. 2023;11(9):570-576
Abstract
OBJECTIVES We aimed to assess the most effective route for Tranexamic acid (TXA) administration among Intraarticular (IA), Intravenous (IV), and combined IA/IV for Total Knee Arthroplasty (TKA) surgeries. METHODS A double-blinded clinical trial was run on 147 TKA candidates. Blood loss and hemoglobin (Hb) drop were evaluated using the Gross and Nadler formula in three matched case groups administered TXA during the TKA through IV, IA, or combined IA/IV route. Tourniquet was used on all operations for controlling intraoperative blood loss. No drainage catheter was used for the cases. RESULTS The combined group showed an average blood loss of 630±252 ml, which was significantly lower than that in the IV group (878±268 ml, P<0.01) and the IA group (774±288 ml, P=0.03). Furthermore, the mean Hb and hematocrit drop were significantly lower in the combined group, compared to the other two groups, 48 and 72 h postoperatively (P<0.05). CONCLUSION The combined IA/IV route had a 28% and 19% reduction of blood loss, compared to the IV or IA methods, respectively. Therefore, using TXA via the combined IA/IV route may be more effective for reducing perioperative blood loss following TKA surgery using a tourniquet without drain placement.
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The Impact of Tourniquet Usage on TKA Outcome: A Single-Center Prospective Trial
Dragosloveanu S, Dragosloveanu C, Petre M, Gherghe ME, Cotor DC
Medicina (Kaunas, Lithuania). 2023;59(5)
Abstract
Background and Objectives: Total knee arthroplasties (TKAs) are the most effective surgical treatment for end-stage knee osteoarthritis. The tourniquet is used to reduce intraoperative blood loss, improving surgical field visualization. There is much controversy regarding the effectiveness and safety of using a tourniquet during total knee arthroplasties. The purpose of this prospective study is to determine the effect of tourniquet usage during TKAs on early functional outcomes and pain in our center. Materials and Methods: We conducted a randomized controlled trial of patients following a primary total knee replacement between October 2020 and August 2021. We recorded presurgical data, which included age, sex and knee range of motion. Intraoperatively, we measured the amount of blood aspiration and the surgical room time. After the surgery, we measured the amount of blood aspirated through the drains and the hemoglobin. We measured flexion, extension, Visual Analogue Scale (VAS) scores, and Western Ontario and McMaster Universities Arthritis Index (WOMAC score) scores for the functional evaluation. Results: We included 96 patients in the T group and 94 in the NT group, respectively, who remained until the last follow-up. Regarding blood loss, the NT group demonstrated significantly lower levels: 245 ± 97.8 mL intraoperative and 324.8 ± 151.65 mL postoperative, compared to the T group, where we recorded 276 ± 109.2 mL during the surgical procedures and 353.44 ± 101.55 mL after the surgery, (p < 0.05). We also recorded significantly shorter operative room time for the NT group, (p < 0.05). During the follow-up, we noticed postoperative improvements but without significant differences between the groups. Conclusions: We found a significant decrease in bleeding after no tourniquet usage during total knee replacements and shorter operative times. On the other hand, the knee function demonstrated no significant differences between the groups. Further studies may be required in order to assess complications.
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Intravenous iron and erythropoietin therapy for postoperative anemia among orthopedic surgery patients
Chen, H., Yu, J., Wei, Q., Zhang, Y., Ouyang, X., Wang, S.
Journal of orthopaedic surgery and research. 2023;18(1):510
Abstract
BACKGROUND Postoperative anemia is a risk factor for adverse surgical outcomes. Our study aimed to assess the role of intravenous iron and erythropoietin therapy for the rapid correction of anemia following orthopedic surgery. METHODS Patients undergoing elective orthopedic surgery were prospectively enrolled and randomly divided into three groups: Control (placebo), Group 1 (IV iron monotherapy), and Group 2 [combined IV iron and recombinant human erythropoietin (rHuEPO) therapy]. Blood tests were performed preoperative (baseline) and on postoperative days (PODs) 1, 3, and 7. RESULTS All groups demonstrated significantly lower hemoglobin (Hb) concentrations compared to baseline, with no significant inter-group differences in postoperative Hb concentrations (p > 0.05). Serum erythropoietin, ferritin, and vitamin B(12) levels, and reticulocyte count increased beyond normal ranges in all groups. Significantly lower serum iron levels were observed postoperatively in all groups (p < 0.05). No significant inter-group differences in hepcidin level were observed (p > 0.05). CONCLUSION Postoperative treatment with combined intravenous iron and rHuEPO was ineffective in correcting postoperative anemia among orthopedic surgery patients, besides achieving higher reticulocyte counts in the first week of surgery. No improvement in mobilization of storage iron was achieved with rHuEPO. We further suggest against vitamin B(12) administration during the early postoperative period.
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Comparison of the effects of different blood conservation techniques in elderly patients undergoing total hip arthroplasty
Cai, Y., He, X., Cheng, Q.
African health sciences. 2023;23(3):514-520
Abstract
BACKGROUND To probe into the influences of different blood conservation techniques on the postoperative coagulation function and prognosis of elderly patients receiving Total Hip Arthroplasty (THA). METHODOLOGY A total of 60 patients were randomly divided into Autologous Blood Transfusion (ABT) group (n=30) and ANH group (n=30). For patients in the ABT group, an autologous blood recovery machine was used to recover, wash and filter the surgical field blood. For those in the Acute Isovolumic Hemodilution (ANH) group, blood was collected preoperatively from the central vein and stored in a citrate anticoagulant blood storage bag, while the same amount of hydroxyethyl starch was injected into the peripheral vein to dilute the blood. After Mai bleeding steps of the operation were completed, the autologous blood of patients was transfused back in both groups. The clinical indicators of patients in each group were observed. RESULTS 48 h after operation, the ANH group obtained a higher level of hemoglobin (Hb), shorter Activated Partial Thromboplastin Time (APTT), and a lower expression rate of platelet activating factor CD62P than the ABT group. CONCLUSION The ANH group exhibits higher content of hemoglobin and fewer platelet (Plt)activating factors produced than the ABT group, while no significant difference in the shortened length of hospital stays is found.
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Medullary cavity application of tranexamic acid to reduce blood loss in tibial intramedullary nailing procedures-a randomized controlled trial
Xiao C, Gao Z, Yu W, Yao K, Cao Y, Long N, Zhang S, Jiang Y
International orthopaedics. 2023
Abstract
PURPOSE Studies have shown an average postoperative hidden blood loss (HBL) of 473.29 ml and an average Hb loss of 16.71 g/l after intramedullary nailing. Reducing HBL has become a primary consideration for orthopaedic surgeons. METHODS Patients with only tibial stem fractures who visited the study clinic between December 2019 and February 2022 were randomized into two groups using a computer-generated form. Two grams of tranexamic acid (TXA) (20 ml) or 20 ml of saline was injected into the medullary cavity before implantation of the intramedullary nail. On the morning of the surgery, as well as on days one, three and five after surgery, routine blood tests and analyses of CRP and interleukin-6 were completed. The primary outcomes were total blood loss (TBL), HBL, and blood transfusion, in which the TBL and HBL were calculated according to the Gross equation and the Nadler equation. Three months after surgery, the incidence of wound complications and thrombotic events, including deep vein thrombosis and pulmonary embolism, was recorded. RESULTS Ninety-seven patients (47 in the TXA group and 50 in the NS group) were analyzed; the TBL (252.10 ± 10.05 ml) and HBL (202.67 ± 11.86 ml) in the TXA group were significantly lower than the TBL (417.03 ± 14.60 ml) and HBL (373.85 ± 23.70 ml) in the NS group (p < 0.05). At the three month postoperative follow-up, two patients (4.25%) in the TXA group and three patients (6.00%) in the NS group developed deep vein thrombosis, with no significant difference in the incidence of thrombotic complications (p = 0.944). No postoperative deaths or wound complications occurred in either group. CONCLUSIONS The combination of intravenous and topical TXA reduces blood loss after intramedullary nailing of tibial fractures without increasing the incidence of thrombotic events.
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The effects of tourniquet use on blood loss and perioperative complications in total knee arthroplasty
Tan, Y., Guo, S., Wang, H., Tie, K., Qin, J., Zhao, X., Chen, L.
BMC musculoskeletal disorders. 2023;24(1):847
Abstract
BACKGROUND There has been ongoing debate about the use of tourniquets in total knee arthroplasty, and their application is widely studied. A comprehensive understanding of the advantages and disadvantages of tourniquet use during the procedure is crucial for optimizing surgical outcomes. This study aimed to investigate the effectiveness of tourniquet application, with a particular focus on blood loss and perioperative complications, providing valuable insights for clinical practice. METHODS Fifty patients who underwent total knee arthroplasty were randomized into tourniquet (n = 25) and nontourniquet (n = 25) groups. The same surgeon performed all surgical procedures. The follow-up time was 14 days after surgery. Primary outcomes were hemoglobin level changes, blood loss, operation time, and perioperative plasma D-dimer levels. Secondary outcomes were postoperative complications, including thrombotic and nonthrombotic events. RESULTS No significant differences were found in drainage, calculated blood loss, total blood loss, postoperative hemoglobin levels, or blood transfusion between the two groups (P > 0.05). No differences in D-dimer levels were observed on postoperative Days 1, 3, and 14 between the two groups, except on postoperative Day 7, when the D-dimer level in the tourniquet group was lower than that in the nontourniquet group (P = 0.03). The incidence of local complications (thigh bruising, blisters, pain, fat liquefaction, and superficial infections) in the tourniquet group was significantly higher than that in the nontourniquet group (P = 0.03), but no significant differences were found in thromboembolic and nonthromboembolic events or overall complications (P > 0.05). CONCLUSION We conclude that tourniquet use does not reduce the length of surgery or blood loss but does increase local complications in total knee arthroplasty.