Efficacy and Safety of Bioabsorbable Bone Hemostatic Agent in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2021;27:10760296211023589
Although a bioabsorbable bone hemostatic agent (BBHA) was developed approximately 20 years ago to overcome the shortcomings of conventional bone wax, its bleeding control capacity has not yet been studied. This study was aimed at investigating the efficacy and safety of BBHA in total knee arthroplasty (TKA). Sixty-two patients who underwent unilateral primary TKA for knee osteoarthritis were included and randomized to the control or BBHA group. Before releasing the tourniquet, BBHA was applied on the bone-cut surface that was not covered by implants. The primary variable was the drainage volume during the postoperative period. The secondary outcomes were total estimated blood loss (EBL), hemoglobin level, hematocrit level, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, range of motion (ROM), pain visual analog scale (VAS) score, and rate of complications. There were no significant differences in drainage volume or EBL between the 2 groups. Hemoglobin and hematocrit levels were higher in the BBHA group during the 4-week postoperative period; however, the intergroup differences were not significant. The ESR, CRP, ROM, and pain VAS scores in the BBHA group were not significantly different from the corresponding values in the control group. No specific complications were observed. Although BBHA was found to be safe without complications, it did not decrease bleeding after TKA in general cases. Further studies are necessary to evaluate the efficacy of BBHA in patients with coagulation problems.
Liberal blood transfusion strategies and associated infection in orthopedic patients: A meta-analysis
OBJECTIVE It remains unclear whether transfusion strategies during orthopedic surgery and infection are related. The purpose of this study is to evaluate whether liberal blood transfusion strategies contribute to infection risk in orthopedic patients by analyzing randomized controlled trials (RCTs). METHODS RCTs with liberal versus restrictive red blood cell (RBC) transfusion strategies were identified by searching PubMed, Embase, the Cochrane Central Register of Controlled Trials from their inception to July 2019. Ten studies with infections as outcomes were included in the final analysis. According to the Jadad scale, all studies were considered to be of high quality. RESULTS Ten trials involving 3938 participants were included in this study. The pooled risk ratio (RR) for the association between liberal transfusion strategy and infection was 1.34 (95% confidence intervals [CI], 0.94-1.90; P = .106). The sensitivity analysis indicated unstable results, and no significant publication bias was observed. CONCLUSION This pooled analysis of RCTs demonstrates that liberal transfusion strategies in orthopedic patients result in a nonsignificant increase in infections compared with more restrictive strategies. The conclusions are mainly based on retrospective studies and should not be considered as recommendation before they are supported by larger scale and well-designed RCTs.
Application of enhanced recovery after surgery in total knee arthroplasty in patients with haemophilia A: A pilot study
Nursing open. 2021;8(1):80-86
AIM: To identify the effect of enhanced recovery after surgery (ERAS) and rapid rehabilitation concepts on the outcomes of patients with haemophilia A undergoing total knee arthroplasty. DESIGN Randomized controlled trial. METHODS The primary endpoint was postoperative hospital stay. The secondary endpoints were pain scores, joint function scores, haemoglobin levels at 3 and 7 days after surgery and satisfaction with hospitalization. RESULTS Thirty-two patients were enrolled. Compared with the routine nursing group, the ERAS group showed shorter postoperative hospital stay (14.2 SD 0.8 vs. 16.6 ± 1.3 days, p < .001), smaller amounts of blood transfusion (924 SD 317 vs. 1,263 SD 449 ml, p = .020) and coagulation factors (37,325 SD 5,996 vs. 48,475 SD 8,019 U, p < .001), lower pain scores at 3 (3.3 SD 0.7 vs. 4.3 SD 0.7, p = .002) and 7 (2.3 SD 0.7 vs. 2.8 ± 0.5, p = .015) days, lower hospital for special surgery knee scores at 3 (59.9 SD 7.8 vs. 53.6 SD 5.9, p = .016) and 7 (77.9 SD 6.9 vs. 71.1 ± 7.1, p = .009) days and higher satisfaction with hospitalization (94.3 SD 1.4 vs. 92.7 SD 1.6, p = .004).
Effect of carbazochrome sodium sulfonate combined with tranexamic acid on blood loss and inflammatory response in patients undergoing total hip arthroplasty
Bone & joint research. 2021;10(6):354-362
AIMS: The purpose of this study was to examine the efficacy and safety of carbazochrome sodium sulfonate (CSS) combined with tranexamic acid (TXA) on blood loss and inflammatory responses after primary total hip arthroplasty (THA), and to investigate the influence of different administration methods of CSS on perioperative blood loss during THA. METHODS This study is a randomized controlled trial involving 200 patients undergoing primary unilateral THA. A total of 200 patients treated with intravenous TXA were randomly assigned to group A (combined intravenous and topical CSS), group B (topical CSS), group C (intravenous CSS), or group D (placebo). RESULTS Mean total blood loss (TBL) in groups A (605.0 ml (SD 235.9)), B (790.9 ml (SD 280.7)), and C (844.8 ml (SD 248.1)) were lower than in group D (1,064.9 ml (SD 318.3), p < 0.001). We also found that compared with group D, biomarker level of inflammation, transfusion rate, pain score, and hip range of motion at discharge in groups A, B, and C were significantly improved. There were no differences among the four groups in terms of intraoperative blood loss (IBL), intramuscular venous thrombosis (IMVT), and length of hospital stay (LOS). CONCLUSION The combined application of CSS and TXA is more effective than TXA alone in reducing perioperative blood loss and transfusion rates, inflammatory response, and postoperative hip pain, results in better early hip flexion following THA, and did not increase the associated venous thromboembolism (VTE) events. Intravenous combined with topical injection of CSS was superior to intravenous or topical injection of CSS alone in reducing perioperative blood loss. Cite this article: Bone Joint Res 2021;10(6):354-362.
What is the ideal route of administration of tranexamic acid in total knee arthroplasty? A meta-analysis based on randomized controlled trials
Annals of palliative medicine. 2021
BACKGROUND Tranexamic acid (TXA) was conducive in total knee arthroplasty (TKA) to reduce blood loss and transfusion demand. The purpose of this meta-analysis was to assess the efficacy and safety of different administration of TXA in primary TKA. METHODS Database PubMed, Medline, Web of Science and Embase were searched. The relative risks (RRs) with 95% confidence intervals (CIs) were calculated to analysis dichotomous outcomes. The mean differences (MD) with 95% CIs were calculated to analysis dichotomous outcomes. Data was analyzed using RevMan 5.3. RESULTS Twenty-eight randomized controlled trials (RCTs) studies were included in this meta-analysis involving a total of 4,200 participants. There were no obvious differences between oral, intravenous or topical TXA group in total blood loss (intravenous vs. topical: MD =11.55, 95% CI, -10.23 to 33.34, oral vs. intravenous or topical: MD =-52.25, 95% CI, -121.28 to 16.78), transfusion rate (intravenous vs. topical: RR =1.04, 95%CI, 0.64 to 1.69, oral vs. intravenous or topical: RR =0.75, 95% CI, 0.36 to 1.54), incidence of venous thrombotic events (VTE) (intravenous vs. topical: RR =1.43, 95% CI, 0.81 to 2.54). The topical TXA administration had significantly increased postoperative hemoglobin (HB) level compared with the intravenous TXA administration (MD =-0.37, 95% CIs, -0.47 to -0.26). In the combined group, the total blood loss (MD =-119.58, 95% CI, -181.68 to -57.49) and postoperative HB level (MD =0.54, 95% CI, 0.45 to 0.64) were more acceptable than the single-route group. CONCLUSIONS Combined administration of TXA can reduce total blood loss, postoperative HB drop compared with intravenous, topical or oral TXA alone. Oral administration of TXA is similar to intravenous or topical TXA use alone.
Impact of tourniquet during knee arthroplasty: a bayesian network meta-analysis of peri-operative outcomes
Archives of orthopaedic and trauma surgery. 2021
INTRODUCTION The role of tourniquet during knee arthroplasty is controversial. The present study compares various tourniquet protocols using a Bayesian network meta-analysis of peri-operative data. MATERIAL AND METHODS The present study was conducted in accordance with the PRISMA extension statement for reporting systematic reviews incorporating network meta-analyses of health interventions. The literature search was conducted in September 2020. All clinical trials investigating the role of tourniquet in knee arthroplasty were considered for inclusion. Methodological quality was assessed using Review Manager 5.3. A Bayesian hierarchical random-effects model analysis was used in all comparisons. RESULTS Ultimately, pooled data from 68 studies (7413 procedures) were analysed. Significant inconsistency was found in the data relating to total estimated blood lost; no assumption could be made on this outcome. Full-time tourniquet resulted in the shortest surgical duration and lowest intra-operative blood lost, in both cases followed by incision-to-suture. The incision-to-suture protocol achieved the smallest drop in haemoglobin during the first 72 h post-operatively and the lowest rate of blood transfusion, both followed by full-time tourniquet. Hospitalisation was shortest in the absence (no-tourniquet) group, followed by the cementation-to-end group. CONCLUSION For knee arthroplasty, longer tourniquet use is associated with the shorter duration of surgery, lower intra-operative blood lost, lower drops in haemoglobin and fewer transfusion units. The shortest average hospitalisation was associated with no tourniquet use.
Tourniquet use in total knee replacement surgery: a feasibility study and pilot randomised controlled trial (SAFE-TKR study)
BMJ open. 2021;11(1):e043564
INTRODUCTION Tourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible. METHODS In a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months. RESULTS We randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated. CONCLUSION A full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial. TRIAL REGISTRATION NUMBER ISRCTN20873088.
The efficacy and safety of high-dose tranexamic acid in adolescent idiopathic scoliosis: a meta-analysis
Journal of orthopaedic surgery and research. 2021;16(1):53
BACKGROUND This study aimed to evaluate the efficacy and safety of using high-dose intravenous tranexamic acid (TXA) to reduce blood loss in idiopathic scoliosis surgery. METHODS This study was a meta-analysis, which consisted of retrospective cohort studies (RCSs) and randomized control trials (RCTs) found by searching electronic databases, namely PubMed, Web of Science, The Cochrane Central Register of Controlled Trials (CENTRAL), and the Google Scholar Database, dating from 1960 to 2019. The points of interest included total blood loss, a need for transfusion and transfusion criteria, surgery time, and the evidence of intraoperative and postoperative complications, such as seizures or thromboembolic events. The weighted mean differences (WMD) and 95% confidence interval (CI) of blood loss in the TXA intervention group compared to the control or placebo group were extracted and combined using the random effects model. RESULTS In this meta-analysis, there was a total of three RCSs and two RCTs, which involved 334 patients. The results showed that blood loss is significantly reduced, with a weighted mean difference in the TXA group (WMD = - 525.14, P = 0.0000, CI ranged from - 839.83, - 210.44, I(2) = 82%). Heterogeneity was assessed using the random effects model. CONCLUSIONS A high dose of intravenous TXA reduced blood loss during adolescent idiopathic scoliosis surgery and did not lead to any significant thromboembolic event. Therefore, a high dose appears to be effective and safe for adolescent idiopathic scoliosis surgery. However, more high-quality research based on larger randomized controlled trials is still needed.
Visualization in arthroscopic meniscectomy- portal-site injection versus tourniquet inflation: A prospective, double-blinded, randomised controlled study
Journal of orthopaedics. 2021;23:233-238
OBJECTIVES Alternatives to tourniquets include portal-site epinephrine injections. This prospective, randomised-controlled, double-blinded study compared intraoperative visibility and safety of portal-site injections with tourniquets in arthroscopic meniscectomies. METHODS Sixty eligible adults [16-55ys, excluding vascular/neuromuscular/systemic illnesses] were randomly/equally divided across 3 groups A (controls)-local portal injections; B-local injections with tourniquet; C-local and 1:200,000epinephrine injections. A single surgeon operated blinded to patient group. Intraoperative visibility, surgeon visual analogue score (VAS)and other details were recorded. RESULTS Superior visibility [p = 0.003,p = 0.027] and VAS [p = 0.010,p = 0.042] were reported in groups B, C versus A, Visibility [p = 0.705; p = 0.805] and operating times [p = 0.05] were comparable between B and C. CONCLUSIONS Portal-site epinephrine injections emerged as tenable surrogates for tourniquets for clear visualization in arthroscopy.
Anesthesia Method, Tourniquet Use, and Persistent Postsurgical Pain after Total Knee Arthroplasty: A Prespecified Secondary Analysis of a Randomized Trial
BACKGROUND Persistent postsurgical pain after total knee arthroplasty is a common problem and a major reason for patient dissatisfaction. This secondary analysis aimed to investigate the effects of anesthesia (spinal vs. general) and tourniquet use on persistent pain after total knee arthroplasty. METHODS In this secondary analysis of a previously presented parallel, single-center, randomized trial, 404 patients scheduled for total knee arthroplasty were randomized to spinal versus general anesthesia and no-tourniquet versus tourniquet groups. Patients assessed pain using the Brief Pain Inventory-short form preoperatively and 3 and 12 months postoperatively. The prespecified main outcome was the change in "average pain" measured with numerical 0 to 10 rating scale 1 yr postoperatively. The threshold for clinical importance between groups was set to 1.0. RESULTS The change in average pain scores 1 yr postoperatively did not differ between the spinal and general anesthesia groups (-2.6 [SD 2.5] vs. -2.3 [SD 2.5], respectively; mean difference, -0.4; 95% CI, -0.9 to 0.1; P = 0.150). The no-tourniquet group reported a smaller decrease in the average pain scores than the tourniquet group (-2.1 [SD 2.7] vs. -2.8 [SD 2.3]; mean difference, 0.6; 95% CI, 0.1 to 1.1; P = 0.012). After 1 yr, the scores concerning the mean of four pain severity variables (numerical rating scale) decreased more in the spinal than in the general anesthesia group (-2.3 [SD 2.2] vs. -1.8 [SD 2.1]; mean difference, -0.5; 95% CI, -0.9 to -0.05; P = 0.029) and less in the no-tourniquet than in the tourniquet group (-1.7 [SD 2.3] vs. -2.3 [SD 2.0]; mean difference, 0.6; 95% CI, 0.2 to 1.0; P = 0.005). None of the differences in pain scores reached the threshold for clinical importance. CONCLUSIONS The type of anesthesia (spinal vs. general) or tourniquet use has no clinically important effect on persistent postsurgical pain after total knee arthroplasty.