Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery
Revista espanola de cirugia ortopedica y traumatologia. 2022
OBJECTIVE Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3 gr of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. MATERIAL AND METHOD A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in two parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. RESULTS Total blood loss (TBL) for the placebo group was 831.5 ml and 662.3 ml for the TXA group. The difference between the two groups was 169.2 ml; which means a save of 20.4 per cent; this difference being statistically significant (p<0.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). CONCLUSION The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.
Perioperative intravenous iron to treat patients with fractured hip surgery: A systematic review and meta-analysis
Health science reports. 2022;5(3):e633
BACKGROUND Treatment of preoperative anemia with intravenous iron is common within elective surgical care pathways. It is plausible that this treatment may improve care for people with hip fractures many of whom are anemic because of pre-existing conditions, fractures, and surgery. OBJECTIVE To review the evidence for intravenous iron administration on outcomes after hip fracture. DESIGN We followed a predefined protocol and conducted a systematic review and meta-analysis of the use of intravenous iron to treat anemia before and after emergency hip fracture surgery. The planned primary outcome was a difference in length of stay between those treated with intravenous iron and the control group. Other outcomes analyzed were 30-day mortality, requirement for blood transfusion, changes in quality of life, and hemoglobin concentration on discharge from the hospital. DATA SOURCES EMBASE, MEDLINE, The Cochrane Library (CENTRAL, DARE) databases, Clinicaltrials.gov, and ISRCTN trial registries. Date of final search March 2022. ELIGIBILITY CRITERIA Adult patients undergoing urgent surgery for hip fracture. Studies considered patients who received intravenous iron and were compared with a control group. RESULTS Four randomized controlled trials (RCT, 732 patients) and nine cohort studies (2986 patients) were included. The RCTs were at low risk of bias, and the nonrandomized studies were at moderate risk of bias. After metanalysis of the RCTs there was no significant difference in the primary outcome, length of hospital stay, between the control group and patients receiving intravenous iron (mean difference: -0.59, 95% confidence interval [CI]; -1.20 to 0.03; I (2) = 30%, p = 0.23). Intravenous iron was not associated with a difference in 30-day mortality (n = 732, OR: 1.14, 95% CI: 0.62-2.1; I (2) = 0%, p = 0.50), nor with the requirement for transfusion (n = 732, OR: 0.85, 95% CI: 0.63-1.14; I (2) = 0%, p < 0.01) in the analyzed RCTs. Functional outcomes and quality of life were variably reported in three studies. CONCLUSION The evidence on the use of intravenous iron in patients with hip fracture is low quality and shows no difference in length of acute hospital stay and transfusion requirements in this population. Improved large, multicentre, high-quality studies with patient-centered outcomes will be required to evaluate the clinical and cost-effectiveness of this treatment.
Application of Different Doses of Tranexamic Acid Plus Traditional Chinese Medicine in Hip Arthroplasty in Patients with Diabetes and Its Influence on Intraoperative Blood Loss and Postoperative Drainage
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:1197495
OBJECTIVE To evaluate the efficacy of different doses of tranexamic acid plus traditional Chinese medicine (TCM) in hip arthroplasty in diabetic patients and the effect on intraoperative hemorrhage and postoperative drainage. METHODS One hundred patients admitted to our hospital from January 2019 to September 2021 were randomly divided into group B (n = 50) and group A (n = 50), and tranexamic acid was injected intravenously at a dose of 10 mg/kg and 20 mg/kg 30 min before skin incision, and then tranexamic acid 1.0 g was injected into the joint cavity through the drainage after incision closure, followed by 3 h of drainage clamping. The amount of blood loss, coagulation index, postoperative drainage, and incidence of venous thromboembolism (VTE) were compared between the groups. RESULTS Group A had significantly less total blood loss, dominant blood loss, and hidden blood loss than group B (P < 0.05). No significant difference in postoperative coagulation indexes and postoperative drainage flow was found between the two groups (P > 0.05). Serological examination results demonstrated no statistical difference in D-dimer (D-D) levels between the two groups. The absence of VTE in both groups was determined by imaging. CONCLUSION Tranexamic acid is effective in reducing intraoperative hemorrhage in diabetic patients undergoing hip arthroplasty. The dose of 20 mg/kg outperforms 10 mg/kg in terms of clinical efficacy with a favorable safety profile, which can be applied according to the patient's actual condition.
Assessment of Short-Term Outcomes of Total Knee Arthroplasty Performed With and Without a Tourniquet
BACKGROUND Tourniquet use has been advocated for better visualization of the surgical field as it exsanguinates most of the blood from the limbs to the central compartment. On the contrary, its use may increase postoperative pain and recovery of quadriceps function, thereby increasing the length of stay (LOS). The study aims to assess short-term outcomes of total knee arthroplasty (TKA) performed with and without a tourniquet. METHODOLOGY Eighty-six patients scheduled for TKA either with or without a tourniquet were selected and divided into two groups using simple random sampling. Knee replacements were performed with a tourniquet in group I and without a tourniquet in group II. In all cases, blood loss was estimated. A visual analog scale (VAS) was used for the assessment of postoperative pain. In the study, range of motion (ROM) and quadriceps lag were also assessed on postoperative day 2 and discharge. RESULTS There were 23 (26.7%) males and 20 (23.2%) females in group I and 28 (32.5%) males and 15 (17.4%) females in group II (p = 0.07). On comparing mean age and body mass index (BMI), statistically insignificant results were obtained. In group I and group II, a statistically significant difference was obtained in the estimation of mean total blood loss as 780.4 ± 152.49 and 1146.2 ± 193.14 ml, respectively (p = 0.02). Neither on postoperative day 2 nor at the time of discharge, no significant results were obtained in observing the ROM at the knee joint and quadriceps lag. CONCLUSION It was found that tourniquet use is associated with lower blood loss and similar postoperative pain, ROM, quadriceps lag, and LOS.
The mid-term and long-term effects of tourniquet use in total knee arthroplasty: systematic review
Journal of experimental orthopaedics. 2022;9(1):42
PURPOSE A tourniquet is routinely used during total knee arthroplasty (TKA) to reduce intra-operative hemorrhage, though surgery without a tourniquet is becoming popular. To address concerns about the effect of blood at cement interfaces on long-term implant stability, we conducted a systematic review among patients undergoing total knee arthroplasty to determine if TKA with a tourniquet, compared to TKA without a tourniquet or with reduced tourniquet duration, is associated with better mid-term and long-term implant stability. METHODS A literature search was conducted without language restriction in PubMed, Cochrane database and Web of Science from conception to 17th March, 2021. Prospective cohorts, randomized and observational, that compared tourniquet use with a control group, followed patients for 3 months or more and reported outcomes concerning implant stability, limb function, pain and inflammation. Article selection, quality assessment according to the Revised Cochrane risk assessment scale and Newcastle Ottawa Scale, and data extraction were conducted in duplicate. PROSPERO CRD42020179020. RESULTS The search yielded 4868 articles, from which 16 randomized controlled trials (RCT) and four prospective cohort studies, evaluating outcomes of 1884 knees, were included. Eleven RCTs were evaluated to be low overall risk of bias, five RCTs had some concerns and four cohort studies were good quality. Few studies showed benefits of tourniquet use in mid-term implant stability (1/6), pain (1/11) and limb inflammation (1/5), and long-term implant stability (1/1). One study reported a significantly improved range of motion (1/14) while another reported significantly reduced quadriceps strength (1/6) in the tourniquet group. The remaining studies reported non-significant effect of tourniquet use. CONCLUSION Although few studies indicated benefits of tourniquet use in mid-term pain, limb inflammation, implant loosening and function, and long-term implant loosening, the majority of studies report no significant advantage of tourniquet use in total knee arthroplasty.
Effects of Platelet-Rich Plasma on Clinical Outcomes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis
Orthopaedic journal of sports medicine. 2022;10(1):23259671211061535
BACKGROUND Many studies have documented the use of platelet-rich plasma (PRP) alongside anterior cruciate ligament (ACL) reconstruction (ACLR) in the management of ACL injury, but evidence on the benefits of PRP in improving the clinical outcomes of ACLR is inconsistent. PURPOSE To help in our understanding, we undertook a systematic review and meta-analysis of randomized controlled trials (RCTs) that evaluated the effects of PRP on patient-reported functional scores, the clinical assessments of knee function and structure, and complications. STUDY DESIGN Systematic review; Level of evidence, 1. METHODS We searched 9 online databases for RCTs published in English or Chinese that examined the effects of PRP on ACLR. The primary outcome measures were visual analog scale (VAS) for pain and International Knee Documentation Committee (IKDC) scores. The secondary outcomes included KT-1000 arthrometer, pivot-shift test, Lysholm and Tegner scores, tunnel widening, graft characterization, and complications. Subgroup analyses were performed according to time of assessments. Fixed- and random-effects models were selected for data analysis. RESULTS A total of 14 studies were included. When PRP was injected to graft tunnels, the pooled VAS scores of the 2 groups were similar (P = .31), and the subgroup analysis found that VAS and IKDC only improved at 3 months postoperatively (P = .0003 and P < .00001, respectively). When PRP was used at the bone-patellar tendon-bone harvest sites, VAS was decreased in the first 6 months postoperatively (P < .00001), whereas IKDC score was not remarkably different (P = .07). After PRP injection, Lysholm scores at 3 months postoperatively was different between the 2 groups (P < .00001), but the Tegner scores (P = .86), KT-1000 measurements (P = .12), the positive rate of pivot-shift test (P = .64), the enlargement of tunnels (femoral, P = .91; tibial, P = .80), and the characterization of grafts (P = .05) were not different. No difference in complications was found in either group. CONCLUSION PRP applied alongside ACLR could reduce postoperative pain and improve knee function in the short and medium terms but is ineffective in the long term. PRP does not improve knee stability and the enlargement of tunnels and does not accelerate the healing of grafts. Further studies would be required.
Tranexamic acid combined with compression dressing reduces blood loss in gluteal muscle contracture surgery
BMC surgery. 2022;22(1):46
BACKGROUND Blood loss and incision-related complications caused by the surgical procedure to release gluteal muscle contracture (GMC) put negative effects on the surgical outcomes. Current procedures to prevent blood loss and complications are not satisfactory. The current study aimed to determine whether tranexamic acid (TXA) in combination with pressure dressing reduce the amount of blood loss, the rate of incision-related complications, and the rate of readmission for patients undergoing surgeries to release GMC. METHODS 49 GMC patients were finally included in the study and were randomly divided into two groups: study group and control group. Patients in both groups received minimally invasive surgery to release GMC except that in the study group, patients were administered a dosage of 20 mg/kg of intravenous TXA preoperatively, and 2 subsequent dosages of TXA at 10 mg/kg at two time points: 3 and 6 h after the first dose. Gauze soaked with TXA was used to pack the wound for 10 min before the incision closure. Then the wound was pressure-wrapped with a hip-spica bandage for 24 h after the surgery in the study group. RESULTS The level of UBL in the study group was significantly lower compared to that in the control group. Similar results were also found for UMHD and UMAD. The incision-related postoperative complications were greatly decreased in the study group compared to those of the control group as well. So was the 30-day readmission rate. All patients in both groups reached "excellent" or "good" level with respect to the postoperative function evaluation. CONCLUSIONS Intravenous and topical application of TXA combined with 24 h pressure hip-spica bandage reduces perioperative blood loss, rate of incision-related complications, and the rate of readmission for GMC patients undergoing minimally invasive surgical releasing procedure. Trial Registration Chinese Clinical and Trial Registry ChiCTR2000039216, registration date 2020/10/22, retrospectively registered.
Effect of Oral Tranexamic Acid on the Blood Transfusion Rate and the Incidence of Deep Vein Thromboembolism in Patients after TKA
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:6041827
PURPOSE To explore the effect of oral tranexamic acid treatment on the blood transfusion rate and the incidence of deep vein thromboembolism after total knee arthroplasty (TKA). METHODS 90 patients undergoing TKA admitted to First People's Hospital of Changshu City from January 2019 to January 2020 were selected and randomized into the control group and the experimental group accordingly (45 cases in each group). The control group intravenously received 20 mL/kg tranexamic acid before the incision was closed. The experimental group was given 1 g of tranexamic acid orally before anesthesia, 6 h and 12 h after the operation. RESULTS The experimental group witnessed better perioperative indexes in relation to the control group. The experimental group displayed better postoperative coagulation function indexes as compared to the control group (P < 0.05). Remarkably lower postoperative vascular endothelial function indexes in the experimental group than in the control group were observed. The experimental group experienced a markedly lower incidence of deep vein thromboembolism in comparison with the control group (P < 0.05). The postoperative knee society score (KSS) score of the experimental group was significantly higher than that of the control group. A significantly higher postoperative modified rivermead mobility index (MRMI) score was yielded in the experimental group in contrast to the control group (P < 0.05). The experimental group obtained lower numerical rating scale (NRS) scores at T2 and T3 as compared to the control group. CONCLUSION Oral tranexamic acid is a suitable alternative for patients undergoing TKA in terms of reducing the blood transfusion rate, relieving pain, and accelerating the recovery of the patient's limbs.
Administration of Tranexamic Acid to Reduce Intra-articular Hemarthrosis in ACL Reconstruction: A Systematic Review
Orthopaedic journal of sports medicine. 2022;10(1):23259671211061726
BACKGROUND Although tranexamic acid (TXA) has been shown to reduce bleeding in joint replacement procedures, its effectiveness for anterior cruciate ligament reconstruction (ACLR) has not been widely reported. PURPOSE To evaluate the effectiveness of TXA to reduce postoperative hemarthrosis and improve clinical outcomes after ACLR. STUDY DESIGN Systematic review; Level of evidence, 2. METHODS A systematic review of the literature following the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) was performed; literature retrieval was carried out using the MEDLINE, Embase, and Cochrane Library electronic databases. The inclusion criteria were comparative studies in English that reported the administration of intravenous or intra-articular TXA versus other modalities or placebo in patients undergoing ACLR. RESULTS Six studies comprising 418 patients who were treated with TXA were included. Heterogeneity among studies did not allow for the pooling of data. Five studies showed decreased drainage volume in the first 24 or 48 hours postoperatively as compared with control (ACLR with no TXA). Four studies showed lower hemarthrosis grades and visual analog scale scores in TXA versus control in the early postoperative period, although this difference was not evident at 4 weeks postoperatively. No studies showed differences in infection, deep venous thrombosis, or adverse events between the TXA and control groups. CONCLUSION The current best available evidence suggests that TXA administration at the time of ACLR results in decreased intra-articular bleeding (measured using a drainage system), hemarthrosis grade, and pain when compared with control.
Leukocyte-Rich and Leukocyte-Poor Platelet-Rich Plasma in Rotator Cuff Repair: A Meta-analysis
International journal of sports medicine. 2022
To systematically review of randomized controlled trials(RCTs) to compared the effects of leukocyte-rich and leukocyte-poor platelet-rich plasma in arthroscopic rotator cuff repair. Two independent reviewers comprehensively searched PubMed, Embase, and Cochrane library databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Comparison of leukocyte-rich platelet-rich plasma or leukocyte-poor platelet-rich plasma in rotator cuff repair in a level I RCTs. Methodological quality assessment was carried out using Cochrane Review Manager 5.3 software. P<0.05 was considered statistically significant. Nine RCTs with 540 patients were included in this review. Meta-analysis showed that leukocyte-poor platelet-rich plasma in significantly reduced retear rate in rotator cuff repair [RR=0.56 95%CI (0.42,0.75); P＜0.05), and in clinical results, the constant score [MD=3.67, 95%CI (1.62,5.73); P=0.0005], UCLA score [MD=1.60, 95%CI (0.79,2.42); P=0.0001], ASES score [MD=2.16, 95%CI(0.12,4.20);P=0.04] were significantly improved. There was a significant result in favor of PRP for the Constant score [MD=-1.24, 95%CI(-1.50,-0.99); P＜0.00001], while SST scores were not significantly different among all groups [MD=0.21, 95%CI(-0.21,0.64); P=0.32]. In conclusion, leukocyte-poor platelet-rich plasma can improved the clinical function and reduced retear rate in arthroscopic rotator cuff repair. In contrast, the efficacy of leukocyte-rich platelet-rich plasma was not significantly improved with the exception of VAS score.