Abstract. Objectives. to evaluate the efficacy and safety of topically applied tranexamic acid (TXA) in thoracolumbar spinal tuberculosis surgery, posterior approach. Methods. Thoracolumbar spine tuberculosis patients who requiring debridement, pedicle screw fixation and fusion surgery were divided into two groups. In the TXA group (n=50), the wound surface was soaked with TXA (1 g in 100 mL saline solution) for 3 minutes after exposure, after decompression, and before wound closure, and in the control group (n=116) using only saline. Intraoperative blood loss, drain volume 48 hours after surgery, amount of blood transfusion, transfusion rate, the haemoglobin, haematocrit after the surgery, the difference between them before and after the surgery, incision infection and the incidence of deep vein thrombosis between the two groups. Results. EBL for the control group was 783.33±332.71 mL and for intervention group 410.57±189.72 mL (p<0.001). The operative time for control group was 3.24±0.38 hours and for intervention group 2.99±0.79 hours (p<0.695). Hemovac drainage on days1 and 2 for control group was 167.10±53.83mL and 99.33±37.5 mL, respectively, and for intervention group 107.03±44.37mL and 53.38±21.99mL, respectively (p<0.001). The length of stay was significantly shorter in the intervention group (4.8±1.1 days) compared to control group (7.0±2.3 days). There was bo different in incision side infection and DVT. Conclusions. Topical TXA is a viable, cost-effective method of decreasing perioperative blood loss in major spine surgery with fewer overall complications than other methods. Further studies are required to find the ideal dosage and timing

Aims

The intra-articular administration of tranexamic acid (TXA) has been shown to be effective in reducing blood loss in unicompartmental knee arthroplasty and anterior cruciate reconstruction. The effects on human articular cartilage, however, remains unknown. Our aim, in this study, was to investigate any detrimental effect of TXA on chondrocytes, and to establish if there was a safe dose for its use in clinical practice. The hypothesis was that TXA would cause a dose-dependent damage to human articular cartilage.

The objective of this trial was to investigate the efficacy of a Comfrey root extract cream in patients with acute upper or lower back pain. The study was conducted as a double-blind, multi-centre, parallel group design RCT over a period of 5 ± 1 days. The patients (n=120, mean age 36.9 years, 46.7 % female) were treated three times a day, 4 g cream per application. The trial included four visits.

The primary efficacy variable was the area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at visits 1 to 4. Among the secondary objectives were back pain at rest (VAS), pressure algometry (pain-time curve; AUC over 5 days), global assessment of efficacy by the patient and investigator, and functional impairment measured with the Oswestry Disability Index.

There was a significant treatment difference between verum and placebo. In the course of the trial the primary variable decreased on average (median) about 95,2 % in the Comfrey extract group and 37.8 % in the placebo group. The results separated by pain location show an equivalent effect of comfrey extract: Regarding pain at rest, in lower back pain a reduction of 98% were observed, in upper back pain 96.9%.

The results of this RCT were clear-cut and consistent across all variables. Comfrey root extract cream showed a remarkably potent and clinically relevant effect in reducing acute back pain. For the first time a fast-acting effect of the ointment (1 hour) was also witnessed in this trial.

The use of antifibrinolytic drugs and many other agents have a critical importance in bleeding control. Tranexamic acid [4- (aminomethyl) cyclohexanecarboxylic acid] is a synthetic amino acid lysine derivative with antifibrinolytic activity in humans. There are many studies in the literature that show that it is effective and effective both systemically and locally in spinal surgery. However, all of these studies have investigated the effects of topical tranexamic acid on bleeding and its effect on fusion has not been investigated yet. Aim of this study is to investigate the effect of topical tranexamic acid on fusion using macroscopic, radiologic and microscopic techniques. After approve of ethics committee with the protocol number 19/2019 for 28 Wistar Albino rats underwent intertransvers fusion. All rats were randomized into four (4) groups, using sealed envelopes. Local tranexamic acid (Transamin® 100 mg/ml, Teva İlaç, İstanbul) doses was determined based on previously conducted studies; 1mg/kg (D1 group), 10mg/kg (D10 group), 100 mg/kg (D100 group) and no tranexamic acid (D0 group). At the end of 8. th. weeks all rats were evaluated with manuel palpation, mammography and histopathologic analysis. Radiographic examination was performed two times to evaluate the intra and inter observer differences. 2 rats in-group D0 died after the radiographic examination. Assessment of fusion with manual palpation revealed that use of local 1mg / kg tranexamic acid had no effect on fusion (p=0.32), however with increasing doses of tranexamic acid had negative effect on fusion (p=0.002). On radiologic examination, spearman's rho correlation coefficient was found to be moderate in the first evaluation (r=0.46) and high in second evaluation (r=0.61). Radiological examination revealed that the control group was the best in fusion (p=0.007), and that tranexamic acid affected fusion adversely, independent of dosage (p=0.27). Among the groups in histopathologic examination, no statistical difference was found (p=0.134). Local administration of tranexamic acid affects the intertransverse fusion adversely depending on the dosage macroscopically and it also affects fusion adversely independent of the dosage radiologically and histopathologically

Background. Tranexamic acid (TXA) and fibrin sealants have gained widespread use in total knee arthroplasty. They can decrease bleeding, drainage volume, hematoma formation, and incidence of blood transfusion. However, they are costly and carry a theoretical risk of infection transmission and thrombosis. This study compares the two pharmacologic interventions to preoperative autologous blood donation as well as no intervention. Methods. This prospective study evaluated a process change within our blood management program over the last five years. The program began initially with a comparison of only routine hemostasis compared to routine preoperative autologous blood donation (PABD) for all patients (Group 1), which then evolved into a targeted PABD protocol where only anaemic patients predonated (Group 2). Subsequently, patients received topical fibrin sealant for a year (Group 3), after which the topical TXA protocol was introduced and is still in place (Group 4). Results. 838 patients went through the blood management protocols. 86 patients (10%) received allogeneic blood: 6 (5%) in Group 1; 18 (9%) in Group 2; 18 (14%) in Group 3; 20 (7%) in Group 4, and 24 (26%) in the control group. No significant difference was observed between the fibrin sealant group and the TXA group with regard to the need for transfusion, but both were significantly lower than controls. The TXA group registered the lowest volume of blood loss, shortest length of stay, and lowest cost. These results were more pronounced in anaemic patients. Conclusion. Both TXA and fibrin sealants were effective in reducing transfusion risk compared to control as well as PABD in primary unilateral total knee arthroplasty. Given the equivalent eαects of both pharmacologic interventions in this study, together with the cost considerations and theoretical harms from the use of blood-derived products, it would seem prudent to use tranexamic acid in preference to fibrin sealants

This edition of Cochrane Corner looks at some of the work published by the Cochrane Collaboration, covering pharmacological interventions for the prevention of bleeding in people undergoing definitive fixation or joint replacement for hip, pelvic, and long bone fractures; interventions for reducing red blood cell transfusion in adults undergoing hip fracture surgery: an overview of systematic reviews; and pharmacological treatments for low back pain in adults: an overview of Cochrane Reviews

Aim. To determine if systemic toxicity occurs after the use of antibiotic loaded calcium sulphate in the treatment (1) of bone and soft tissue infection. Although antibiotic loaded calcium sulphate is increasingly used for the local treatment of bone and soft tissue infection, there is little data to demonstrate that systemic levels generated by local release of antibiotics are safe. For this reason, we routinely assay systemic levels of antibiotics. Methods. Patients with osteomyelitis or soft tissue infection underwent surgical debridement and lavage of the infected tissue in routine fashion. Patients with osteomyelitis were graded with the Cierny-Mader classification. Bone cavities and soft tissue dead spaces were packed with antibiotic loaded calcium sulphate (10–40 cc) loaded with Vancomycin (1–4 g) and Gentamicin (240–960 mg). The wounds were closed over the antibiotic loaded calcium sulphate. Patients underwent serial assays of Vancomycin and Gentamicin levels on the day of surgery and the first two post-operative days. Renal function was also measured. Results. 12 limbs in 10 patients were treated for osteomyelitis or soft tissue infection. There was 1 Cierny-Mader grade 1, 3 Cierny-Mader grade 3, and 2 Cierny-Mader grade 4. Two had deep soft tissue infection alone. There were 3 type A hosts and 7 type B hosts. The patients age ranged from 24 to 89 (mean 54). In patients without renal dysfunction, the systemic levels were either unmeasurable at the first assay, or below the acceptable trough level. (Mean 2.4 and 1.8 for Vancomycin and Gentamycin respectively). They had unmeasurable systemic levels at the third assay. In patients with renal dysfunction, systemic levels were in the therapeutic range determined for systemically administered antibiotics, but these levels remained high and did not decrease until patients had undergone their routine dialysis. Conclusions. In patients treated with antibiotic loaded Stimulan, antibiotic assays are not necessary in patients who have normal renal function, as they clear the systemic absorption as quickly as it is generated. Patients with impaired renal function should have lower doses of antibiotic used for their topically applied carrier, and should undergo assays regularly to ascertain if levels are remaining below the accepted range determined for systemically administered antibiotics. If they remain high, the antibiotic loaded calcium sulphate could be removed. * Stimulan (Biocomposites, Keele, UK)

Introduction. Infections in total joint arthroplasty (TJA) are a burden to the healthcare system. An infection in total joint arthroplasty costs nearly $60,000–80,000 to the system. 3 major tenets to decrease surgical site infections, focus on patient preoperative optimization, intraoperative techniques, and postoperative care. Intraoperative vancomycin powder been successful in lowering infection rates in other areas of orthopaedics. The purpose of our study was to investigate whether topical intraoperative vancomycin powder had any effect on surgical site infection, complication rate, or reoperation rate. Our hypothesis was vancomycin powder may decrease the rate of surgical site infections without any effect on wound complications. Materials & Methods. 208 consecutive patients undergoing either total hip or total knee arthroplasty (THA or TKA) were given intraoperative vancomycin powder or none. 64 patients received vancomycin poweder compared to 164 patients who did not. All preoperative, intraoperative and postoperative management was similar. Preoperative data including age, sex, BMI, diabetes status and comorbidities were recorded. Surgical techniques included medial parapatellar or subvastus for TKA, posterolateral for THA. 90-day culture positive infection and reoperation rates were recorded. Results. Preoperative variables between the two groups were similar. Average age, ASA, BMI, diabetes status and other preoperative patient variables were not significantly different (p=0.31, 0.19, 0.65, 0.31). 5/64 patients (7.8%) in the vancomycin group underwent reoperation, compared with 13/164 (9.0%) in the no vancomycin group. There was no difference in the rate of reoperations (p=0.777). Of these patients, 3/64 (4.69%) patients in the vancomycin group had a positive infection compared with 8/164 (5.55%) in the no vancomycin group. There was no significant differences between the two infection rates (p=0.807). Discussion. Surprisingly, vancomycin powder did not have any effect on reoperation nor infection rates in our study group. Although other studies may have shown a decrease in infection, ours failed to do so. Due to low study numbers, we could not differentiate deep versus superficial surgical site infections. Based on our study, we are unable to recommend the use of intraoperative vancomycin powder for total joint arthroplasty

Objectives

We have increased the dose of tranexamic acid (TXA) in our enhanced total joint recovery protocol at our institution from 15 mg/kg to 30 mg/kg (maximum 2.5 g) as a single, intravenous (IV) dose. We report the clinical effect of this dosage change.

Soaking bone grafts in a bisphosphonate solution before implantation can prevent their resorption and increase the local bone density in rats and humans. However, recent studies suggest that pre-treatment of allografts with bisphosphonate can prevent bone ingrowth into impaction grafts. We tested the hypothesis that excessive amounts of bisphosphonate would also cause a negative response in less dense grafts. We used a model where non-impacted metaphyseal bone grafts were randomised into three groups with either no bisphosphonate, alendronate followed by rinsing, and alendronate without subsequent rinsing, and inserted into bone chambers in rats. The specimens were evaluated histologically at one week, and by histomorphometry and radiology at four weeks. At four weeks, both bisphosphonate groups showed an increase in the total bone content, increased newly formed bone, and higher radiodensity than the controls. In spite of being implanted in a chamber with a limited opportunity to diffuse, even an excessive amount of bisphosphonate improved the outcome. We suggest that the negative results seen by others could be due to the combination of densely compacted bone and a bisphosphonate.

We suggest that bisphosphonates are likely to have a negative influence where resorption is a prerequisite to create space for new bone ingrowth.

Objectives

The period of post-operative treatment before surgical wounds are completely closed remains a key window, during which one can apply new technologies that can minimise complications. One such technology is the use of negative pressure wound therapy to manage and accelerate healing of the closed incisional wound (incisional NPWT).

We investigated the effect of mitomycin-C on the reduction of the formation of peritendinous fibrous adhesions after tendon repair. In 20 Wistar albino rats the tendo Achillis was cut and repaired using a modified Kessler technique. The rats were divided into two equal groups. In group 1, an injection of mitomycin-C was placed between the tendon and skin of the right leg. In group 2, an identical volume of sterile normal saline was injected on the left side in a similar fashion. All the rats received mitomycin-C or saline for four weeks starting from the day of operation. The animals were killed after 30 days. The formation of peritendinous fibrous tissue, the inflammatory reaction and tendon healing were evaluated. The tensile strength of the repaired tendons was measured biomechanically. Microscopic evidence of the formation of adhesions and inflammation was less in group 1. There was no significant difference in the tensile load required to rupture the repaired tendons in the two groups.

Mitomycin-C may therefore provide a simple and inexpensive means of preventing of post-operative adhesions.

Ciprofloxacin hydrochloride-loaded microspheres were prepared by a spray-drying method using pectin and chitosan. The effects of different polymers and drug ratios were investigated.

The most appropriate carriers were selected by in vitro testing. A rat methicillin-resistant Staphylococcus aureus osteomyelitis model was used to evaluate the effects of the loaded microspheres.

The drug was released rapidly from the pectin carrier but this was more sustained in the chitosan formulation.

Chitosan microspheres loaded with ciprofloxacin hydrochloride were more effective for the treatment of osteomyelitis than equivalent intramuscular antibiotics.