Clinical Effectiveness of Intraoperative Tranexamic Acid Use in Shoulder Surgery: A Systematic Review and Meta-analysis
The American journal of sports medicine. 2021;:363546520981679
BACKGROUND Tranexamic acid (TXA) is widely used across surgical specialties to reduce perioperative bleeding. It has been shown to be effective in spinal surgery and lower limb arthroplasty. Among all languages, there are no systematic reviews or meta-analyses investigating its clinical effectiveness for all types of shoulder surgery. PURPOSE To investigate the clinical effectiveness of TXA in all types of shoulder surgery, including open and arthroscopic procedures. To investigate the effect of TXA on bleeding and non-bleeding-related outcomes. STUDY DESIGN Systematic review and meta-analysis. METHODS A protocol for the study was designed and registered with PROSPERO (CRD42020185482). The literature search included the MEDLINE, Embase, PsycINFO, and Cochrane Library databases. All randomized controlled trials evaluating the use of TXA against placebo, in all types of shoulder surgery, were included. Assessments were undertaken for risk of bias and certainty of evidence. The primary outcome was total blood loss. Secondary outcomes included those not directly related to bleeding. Data from comparable outcomes were pooled and analyzed quantitatively or descriptively, as appropriate. RESULTS Eight randomized controlled trials were included in the systematic review, and data from 7 of these studies were pooled in the meta-analysis. Pooled analysis demonstrated a significant reduction in 2 of 3 outcomes measuring perioperative bleeding with TXA compared with controls: estimated total blood loss (mean difference, -209.66 mL; 95% CI, -389.11 to -30.21; P = .02) and postoperative blood loss as measured by drain output (mean difference, -84.8 mL; 95% CI, -140.04 to -29.56; P = .003). Hemoglobin reduction was reduced but not statistically significant (mean difference, -0.33 g/dL; 95% CI -0.69 to 0.03; P = .07). This result became significant with sensitivity analysis excluding arthroscopic procedures. CONCLUSION This systematic review and meta-analysis indicated that TXA was effective in reducing blood loss in shoulder surgery. Larger randomized controlled trials with low risk of bias for specific surgical shoulder procedures are required. CLINICAL RELEVANCE TXA can be used across shoulder surgery to reduced perioperative blood loss. The use of TXA may have other beneficial features, including reduced postoperative pain and reduced operative time.
Effect of 4DryField® PH on blood loss in hip bipolar hemiarthroplasty following intracapsular femoral neck fracture - a randomized clinical trial
BMC musculoskeletal disorders. 2021;22(1):113
BACKGROUND One of the most common complications of hip arthroplasty is excessive blood loss that could necessitate allogenic blood transfusion, which is further associated with other complications, such as infections, transfusion reactions or immunomodulation. In gynecology, 4DryField®PH, an absorbable polysaccharide-based formulation, is used for hemostasis and adhesion prophylaxis. In this study, we evaluated its hemostatic effect in patients undergoing hip bipolar hemiarthroplasty following intracapsular femoral neck fracture. METHODS We studied 40 patients with intracapsular femoral neck fractures (Garden III or IV) admitted at our institution between July 2016 and November 2017. We included patients above 60 years with simple fracture and without pathologic fractures. Patients were randomized into intervention and control groups. The intervention group received 5 g of 4DryField® PH (subfascially and subcutaneously) during wound closure. Three drainages were inserted in a standardized manner (submuscular, subfascial, and subcutaneous) and drainage volume was measured immediately before extraction. Total blood loss was calculated using Mercuriali's formula and standard hemograms upon admission and five days after surgery. Volume of postoperative hematoma was measured using point-of-care ultrasound seven days after surgery. RESULTS Volume of the postoperative hematoma was reduced by 43.0 mL. However, significant reduction of total blood loss and drainage volume was not observed. CONCLUSIONS We observed that 4DryField® PH had a local hemostatic effect, thereby reducing volume of the postoperative hematoma. However, this reduction was small and had no effect on the total blood loss. Further studies are warranted to improve the application algorithm. TRIAL REGISTRATION DRKS, DRKS00017452 , Registered 11 June 2019 - Retrospectively registered.
Effect of 0.9% NaCl compared to plasma-lyte on biomarkers of kidney injury, sodium excretion and tubular transport proteins in patients undergoing primary uncemented hip replacement - a randomized trial
BMC nephrology. 2021;22(1):111
BACKGROUND Isotonic saline (IS) is widely used to secure perioperative cardiovascular stability. However, the high amount of chloride in IS can induce hyperchloremic acidosis. Therefore, IS is suspected to increase the risk of acute kidney injury (AKI). Biomarkers may have potential as indicators. METHODS In a double-blinded, placebo-controlled study, 38 patients undergoing primary uncemented hip replacement were randomized to IS or PlasmaLyte (PL). Infusion was given during surgery as 15 ml/kg the first hour and 5 ml/kg the following two hours. Urinary samples were collected upon admission and the day after surgery. As surgery was initiated, urine was collected over the course of 4 h. Hereafter, another urine collection proceeded until the morning. Urine was analyzed for markers of AKI neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1). Arterious and venous blood samples for measurements of pH and plasma electrolytes including chloride (p-Cl) were collected as surgery was initiated, at the end of surgery and the following morning. RESULTS IS induced an increase in p-Cl (111 ± 2 mmol/L after IS and 108 ± 3 after PL, p = 0.004) and a decrease in pH (7.39 ± 0.02 after IS and 7.43 ± 0.03 after PL, p = 0.001). Urinary NGAL excretion increased in both groups (ΔNGAL: 5.5 [4.1; 11.7] μg/mmol creatinine p = 0.004 after IS vs. 5.5 [2.1;9.4] μg/mmol creatinine after PL, p < 0.001). No difference was found between the groups (p = 0.839). Similarly, urinary KIM-1 excretion increased in both groups (ΔKIM-1: IS 115.8 [74.1; 156.2] ng/mmol creatinine, p < 0.001 vs. PL 152.4 [120.1; 307.9] ng/mmol creatinine, p < 0.001). No difference between the groups (p = 0.064). FE(Na) increased (1.08 ± 0.52% after IS and 1.66 ± 1.15% after PL, p = 0.032). ENaC excretion was different within groups (p = 0.019). CONCLUSION A significantly higher plasma chloride and a lower pH was present in the group receiving isotonic saline. However, u-NGAL and u-KIM-1 increased significantly in both groups after surgery despite absence of changes in creatinine. These results indicate that surgery induced subclinical kidney injury. Also, the IS group had a delayed sodium excretion as compared to the PL group which may indicate that IS affects renal sodium excretion differently from PL. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02528448 , 19/08/2015.
Efficacy of Intraoperative Platelet-Rich Plasma Augmentation and Postoperative Platelet-Rich Plasma Booster Injection for Rotator Cuff Healing: A Randomized Controlled Clinical Trial
Orthopaedic journal of sports medicine. 2021;9(6):23259671211006100
BACKGROUND Platelet-rich plasma (PRP) has been applied as an adjuvant treatment for arthroscopic rotator cuff repair (ARCR) to enhance rotator cuff healing. However, it remains debatable whether PRP enhances tendon-to-bone healing. PURPOSE To assess the efficacy of intraoperative augmentation and postoperative injection of PRP that was prepared using the double-spin method and calcium activation without thrombin in patients with ARCR. STUDY DESIGN Randomized controlled trial; Level of evidence, 1; and cohort study; Level of evidence, 3. METHODS A total of 58 patients underwent ARCR using intraoperative PRP augmentation. Half of the patients were randomly assigned to receive an additional ultrasound-guided PRP injection at the repair site at 2 weeks postoperatively (PRP-booster group); the other half did not receive the booster injection (PRP-only group). A control group that did not receive any PRP treatment was retrospectively matched using propensity score matching. Structural integrity was assessed using magnetic resonance imaging at 1 year postoperatively, and healing rates were compared between patients with tear sizes ≤2 cm versus >2 cm. Functional outcomes were assessed using the visual analog scale (VAS) for pain; VAS for satisfaction; shoulder range of motion; and Constant, American Shoulder and Elbow Surgeons, and Simple Shoulder Test scores at minimum 2-year follow-up. RESULTS In patients with tears >2 cm, the rate of healing failure at 1-year follow-up was significantly less in the overall PRP group than in the control group (12.9% vs 35.7%, respectively; P = .040), however, the PRP-booster group did not present a better healing rate than did the PRP-only group. The overall PRP group had lower VAS for pain scores compared with the control group (0.5 ± 1.1 vs 1.3 ± 1.8, respectively; P = .016) and higher VAS for satisfaction scores (9.2 ± 1.2 vs 8.6 ± 1.7; P = .023) at the final follow-up, whereas no statistical difference was found between the PRP-only and PRP-booster groups in functional outcomes. CONCLUSION Intraoperative PRP augmentation during ARCR demonstrated superior anatomic healing results in patients with rotator cuff tears >2 cm as well as reduced pain and increased subjective satisfaction. PRP booster injection provided no additional benefit to tendon integrity or functional recovery.
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 during knee arthroplasty: A Bayesian network meta-analysis on pain, function, and thromboembolism
The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland. 2021
BACKGROUND The role of a tourniquet for knee arthroplasty remains controversial. The present Bayesian network meta-analysis investigated the role of various protocols for tourniquet inflation for knee arthroplasty, assessing data on pain control, clinical and functional outcomes, and the rate of deep vein thrombosis (DVT). MATERIAL AND METHODS The present Bayesian network meta-analysis was conducted according to the PRISMA guidelines. In March 2021, all clinical trials investigating the role of tourniquet use for knee arthroplasty were considered for inclusion. Groups were divided into those which used a tourniquet in knee arthroplasty procedures versus those which completed the procedure without tourniquet, or with varying protocols of tourniquet use. The hierarchical random-effects model analysis was adopted in all comparisons. RESULTS Data from 54 articles (5497 procedures) were retrieved. The absence of tourniquet group evidenced the lowest rate of DVT, and scored the lowest in the visual analogic scale (VAS) at 24-48 h, 1, 3, and 12 months follow-up. The same group evidenced the greatest gain of motion at 3-days, 1 week, 1 month, 3 months, 6 months, and 12 months follow-up, and the highest Knee Society Rating System scores at 1, 3, and 12 months follow-up. Of the outcome data assessed, the straight-leg-raise test was markedly inconsistent: therefore, no recommendations from this test can be made. CONCLUSION With regards to the endpoints considered in the present study, knee arthroplasties undertaken without the use of a tourniquet perform better overall.
Application of Tourniquet Does Not Influence Early Clinical Outcomes After Total Knee Arthroplasty
Introduction The use of a tourniquet during total knee arthroplasty (TKA) is still a topic of debate, given the conflicting results in the literature with respect to complications, pain, functional outcome, and blood loss. However, due to a lack of convincing data on early patient-reported outcomes (PROMS), this study aims to compare pain and functional outcomes in total knee arthroplasty patients with and without a tourniquet. Methods A randomized controlled trial was set up at a tertiary care hospital that spanned from 1(st) February 2015 to 31(st) July 2018. We included all primary total knee arthroplasties performed for patients aged between 50 and 80 years. Oxford Knee Score (OKS), Numerical Pain Rating Score (NPRS), Visual Analogue Scale (VAS) for satisfaction, active range of knee motion, and Short Form-12 Survey (SF-12) scores were collected pre-surgery and then at six-weeks and six-months interval with a p-value of 0.05 considered to be significant. Results Two hundred and forty patients participated in the study; 117 patients were randomized to surgery with the tourniquet inflated and 123 to surgery with the tourniquet deflated. There were 43.4% males, and 56.6% females in the tourniquet inflated group with an average age of 62.29±9.63 years while in tourniquet deflated group, there were 46.7% males and 53.3% females with a mean age of 65.41±9.042 years (p-value for age is 0.404; the p-value for gender is 0.086). Despite the increase in intraoperative blood loss in both the groups, there was no significant increase in blood transfusions as both groups recorded the need for postoperative blood transfusion - 12 patients in the tourniquet group and 19 in the non-tourniquet group, but this difference was statistically insignificant (p=0.231). The perioperative blood loss was significantly lower (p<0.001) in the tourniquet group (490.29±47.752) compared to in the non-tourniquet group (526.18±12.796), while the duration of surgery was comparable in both groups (p=0.156). The length of stay for the two groups did not statistically differ (p=0.976) - the mean length of stay for the tourniquet group was 6.16±2.38 days and for the non-tourniquet group it was 6.18±2.34 days. There were no significant differences between the two groups regarding patient-reported outcomes (PROMS) at six-weeks and six-months. However, during the in-hospital stay, only the NPRS score for knee pain showed that the non-tourniquet patients had a lower NPRS compared to the tourniquet group and this difference was statistically significant (p=0.02). During the postoperative hospital stay, there was no significant difference among the two treatment groups for VAS, OKS, SF-12, and range of motion (flexion/extension). At the six weeks follow-up, both groups had similar outcomes for the range of movements and pain scores. Besides, no difference was noted among the tourniquet and non-tourniquet groups even after a follow-up of six months. Regarding complications, 27 patients in the tourniquet group did complain of numbness during the study period compared to 10 in the non-tourniquet group (p=0.001). Conclusion In conclusion, a tourniquet application helps minimize intraoperative blood loss and results in a faster procedure. Furthermore, the application of the tourniquet is safe and effective and does not affect the functional outcomes and pain scale in total knee arthroplasty.
Effects of Tourniquet Application on Faster Recovery after Surgery and Ischemia-Reperfusion Post-Total Knee Arthroplasty, Cementation through Closure versus Full-Course and Nontourniquet Group
The journal of knee surgery. 2021
Pneumatic tourniquets are used in total knee arthroplasty (TKA) for surgical field visualization and improved cementation; however, their use is controversial. This study aimed to assess the effects of tourniquet application on faster recovery post-TKA. Our hypothesis was that inflammation and limb function would be similar with different tourniquet applications. A prospective randomized double-blinded trial assessed tourniquets effects on postoperative pain, swelling, and early outcome in TKA. In present study, 50 TKAs were enrolled in each group as follows: full course (FC), cementation through closure (CTC), and no tourniquet (NT), CTC as treatment group while FC and NT as control groups. Topical blood samples of 3 mL from the joint cavity and drainage bags were obtained at special time point. At last, all samples such as tumor necrosis factor-a (TNF-a), C-C motif chemokine ligand 2 (CCL2), pentraxin 3 (PTX3), prostaglandin E2 (PGE2), superoxide dismutase 1 (SOD1), and myoglobin (Mb) were detected by ELISA. Active and passive range of motion (ROM) values, pain score by the visual analog scale (VAS), change of thigh circumference were recorded at special time point as well. In topical blood, the change of inflammatory factors, such as TNF-a, PTX3, CCL2, PGE2, SOD1, and Mb, was lower in CTC and NT groups than in FC group (p < 0.01 and 0.05). Although VAS and ROM were comparable preoperatively in three groups (p > 0.05), the perimeter growth rate was lower, pain scores (VAS) were reduced, and ROM values were improved in CTC and NT groups compared with FC group at T4, T5, and T6 postoperatively (p < 0.01 and 0.05). Improved therapeutic outcome was observed in the CTC group, indicating patients should routinely undergo TKA with cementation through closure tourniquet application.
Platelet rich plasma in arthroscopic rotator cuff repair: clinical and radiological results of a prospective RCT study at 10-year follow-up
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2021
PURPOSE The aim of the study is to compare, at 10-year follow-up, the clinical and radiological outcomes of arthroscopic rotator cuff repair with or without the addition of platelet-rich plasma (PRP) over the tendon-bone interface at the end of the surgical procedure. METHODS Of 53 patients recruited in the study, and randomly divided into two groups (PRP=26; control=27), 38 were re-evaluated at least 10 years after the index procedure. The clinical evaluation was carried out through: University of California at Los Angeles (UCLA) Shoulder Score, Visual Analogue Scale (VAS), Simple Shoulder Test (SST), Constant-Murley Score (CMS), Single Assessment Numerical Evaluation (SANE), American Shoulder and Elbow Surgeons (ASES) and isometric strength in abduction, forward flexion and external rotation. Musculoskeletal ultrasound had been used to evaluate the integrity of the repaired cuff. RESULTS A number of 38 (71%) patients (PRP=17; control=21) with a median age of 71 [64.75-76.50] years have been evaluated. Satisfaction at follow-up is high (90%), without statistically significant difference between the two groups. We report good and excellent clinical results in both groups (PRP vs control): CMS (81.62 [72.47-85.75] vs 77.97 [69.52-82.55] points), UCLA (34 [29.00-35.00] vs 33 [29.00-35.00] points), VAS (0.34 [0.00-1.85] vs 0.70 [0.00-2.45] cm). It was not possible to find a statistically significant difference for the variables analysed, except for ASES and SANE. On average, 37% of the operated patients had a re-rupture at the ultrasound examination, regardless the treatment group (p=1.00). Compared with the previous radiological control at the 2-year follow-up, new retears occurred in 6% of the patients that received PRP treatment, whereas in the control group the percentage raises to 14% (p=0.61). CONCLUSION The clinical and radiological outcomes at the 10-year follow-up show a substantial uniformity of results between the two groups. The minor differences that had been observed at 2-year follow-up disappeared at long term. Patients' satisfaction is still high 10 years after surgical treatment.
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.