Abstract

BACKGROUND The aim of this trial was to assess the effectiveness of quality improvement collaboratives to implement large-scale change in the National Health Service (NHS) in the UK, specifically for improving outcomes in patients undergoing primary, elective total hip or knee replacement. METHODS We undertook a two-arm, cluster randomised controlled trial comparing the roll-out of two preoperative pathways: methicillin-sensitive Staphylococcus aureus (MSSA) decolonisation (infection arm) and anaemia screening and treatment (anaemia arm). NHS Trusts are public sector organisations that provide healthcare within a geographical area. NHS Trusts (n = 41) in England providing primary, elective total hip and knee replacements, but that did not have a preoperative anaemia screening or MSSA decolonisation pathway in place, were randomised to one of the two parallel collaboratives. Collaboratives took place from May 2018 to November 2019. Twenty-seven Trusts completed the trial (11 anaemia, 16 infection). Outcome data were collected for procedures performed between November 2018 and November 2019. Co-primary outcomes were perioperative blood transfusion (within 7 days of surgery) and deep surgical site infection (SSI) caused by MSSA (within 90 days post-surgery) for the anaemia and infection trial arms, respectively. Secondary outcomes were deep and superficial SSIs (any organism), length of hospital stay, critical care admissions and unplanned readmissions. Process measures included the proportion of eligible patients receiving each preoperative initiative. RESULTS There were 19,254 procedures from 27 NHS Trusts included in the results (6324 from 11 Trusts in the anaemia arm, 12,930 from 16 Trusts in the infection arm). There were no improvements observed for blood transfusion (anaemia arm 183 (2.9%); infection arm 302 (2.3%) transfusions; adjusted odds ratio 1.20, 95% CI 0.52-2.75, p = 0.67) or MSSA deep SSI (anaemia arm 8 (0.13%); infection arm 18 (0.14%); adjusted odds ratio 1.01, 95% CI 0.42-2.46, p = 0.98). There were no significant improvements in any secondary outcome. This is despite process measures showing the preoperative pathways were implemented for 73.7% and 61.1% of eligible procedures in the infection and anaemia arms, respectively. CONCLUSIONS Quality improvement collaboratives did not result in improved patient outcomes in this trial; however, there was some evidence they may support successful implementation of new preoperative pathways in the NHS. TRIAL REGISTRATION Prospectively registered on 15 February 2018, ISRCTN11085475.

Abstract

PURPOSE To investigate whether local administration of epsilon-aminocaproic acid (EACA) is effective and safe in reducing the post-operative blood loss in surgery for Sanders III-IV calcaneal fractures. METHODS Patients with Sanders III-IV calcaneal fractures who were hospitalized in our hospital from January 2016 to February 2021 and underwent open reduction internal fixation (ORIF) via lateral approach with an L-shaped incision were included in the current study. Eighty five patients were randomly divided into two groups, EACA group (43) and control group (42). Twenty milliliters of 5% EACA solution or normal saline was perfused into the incision of patients in EACA group and control group, respectively. The volume of post-operative drainage was investigated as the primary outcome. Post-operative blood test, coagulation test, and wound complications were analyzed as the secondary outcomes. RESULTS The volume of post-operative drainage at 24 and 48 h was 164.8 ± 51.4 ml, 18.9 ± 3.8 ml for patients in EACA group, and 373.0 ± 88.1 ml, 21.2 ± 4.4 ml for patients in the control group, respectively. EACA greatly reduced the post-operative blood loss compared to the control (normal saline). The difference between the two groups was statistically significant. No statistically significant difference was found between EACA group and control group with regard to the pre-operative, baseline characteristics. Post-operative blood test results demonstrated that haemoglobin and hematocrit were significantly higher in EACA compared to those of control group. No significant difference was found between EACA group and control group in terms of the platelet counts, prothrombin time (P.T.), activated partial prothrombin time (APTT), and wound complications. CONCLUSION Local administration of EACA is effective in post-operative blood loss reduction in ORIF surgeries for Sanders III-IV types of calcaneal fractures without increasing the incidence of periwound complication.

Abstract

STUDY OBJECTIVE Preoperative anemia results in two- to sixfold increased incidence of perioperative blood transfusion requirements and reduced postoperative hemoglobin (Hb) level. This prospective study was designed to investigate the effect of preoperative intravenous infusion of iron on Hb levels, blood transfusion requirements, and incidence of postoperative adverse events in patients undergoing coronary artery bypass grafting. DESIGN Prospective randomized trial. SETTING Academic university hospital. PATIENTS Eighty patients (52-67 years old) underwent coronary artery bypass grafting and received either iron therapy or saline infusion preoperatively. INTERVENTIONS Patients were randomly allocated to iron or placebo groups. In the iron group, patients received a single intravenous dose of ferric carboxymaltose (1000 mg in 100 mL saline) infused slowly over 15 min 7 days before surgery. In placebo group, patients received a single intravenous dose of saline (100 mL saline) infused slowly over 15 min 7 days before surgery. MEASUREMENTS Patients were followed up with regards to incidence of anemia, Hb level on admission, preoperatively, postoperatively, 1 week and 4 weeks after discharge, aortic cross-clamp time, the number of packed red blood cells (pRBCs) units, the percentage of reticulocytes pre-postoperatively and 1 week later, hospital stay and intensive care unit (ICU) stay length, and the incidence of postoperative complications. MAIN RESULTS Iron therapy was associated with lower incidence of anemia 4 weeks after discharge (P < 0.001). Hb level was significantly higher in the iron group compared to the placebo group preoperatively and postoperatively, and 4 weeks after discharge (P < 0.001). Iron therapy resulted in shorter hospital and ICU stay (P < 0.001) and shorter aortic cross-clamp time, reduced pRBCs requirements postoperatively. Percentage of reticulocytes was significantly higher in placebo group than in iron group postoperatively and 1 week after discharge and the incidence of postoperative complications was similar to the placebo group. CONCLUSIONS Preoperative IV iron infusion is a safe and feasible way to manage preoperative anemia. Preoperative administration of IV iron is associated with a higher postoperative Hb level, shorter hospital and ICU stay, and reduced perioperative red blood cell transfusion requirements with insignificant difference in incidence of postoperative complications.

Abstract

Background Total knee arthroplasty (TKA) is a procedure that has improved the quality of life of patients with knee arthritis. Postoperative pain and blood loss are the two major drawbacks of TKA which affect patient satisfaction and delay recovery and rehabilitation. Local infiltration analgesia has shown better results in controlling immediate postoperative pain, thus enabling early rehabilitation and mobilization, while local infiltration of antifibrinolytic agents has shown impressive results in controlling blood loss. In this study, we evaluate the effect of a combination of intra-articular infiltration of ropivacaine cocktail along with intra-articular instillation of tranexamic acid in reducing patient-reported postoperative pain and the level of blood loss control after TKA. Methodology Patients presenting with high-grade osteoarthritis and undergoing TKA were included and randomly allocated to two groups: one receiving the intra-articular infiltration (group A), and the other not receiving any infiltration (group B). Postoperative pain was measured through the Visual Analog Scale (VAS) every three hours for the first 24 hours, and then at 48 hours and 72 hours postoperatively. The need for additional analgesia, in the form of a slow epidural infusion, in patients experiencing severe postoperative pain was evaluated in both groups. Postoperative blood loss was assessed by measuring total drain output (in mL) and by comparing preoperative and postoperative (at 24 hours) hemoglobin, hematocrit drift, and blood transfusion rates. The duration of the postoperative hospital stay and the time taken to start postoperative knee mobilization exercises and weight-bearing were noted to assess the recovery and rehabilitation of the patients in the two groups. Results The study included 42 patients (group A, 22 patients; group B, 20 patients) with 28 knees in each group. Patients with intra-articular infiltration using ropivacaine cocktail with tranexamic acid showed excellent pain control compared to the non-infiltrated patients in the early 48 hours postoperatively. There was a significant drop in postoperative hemoglobin and hematocrit values in the non-infiltrated patients compared to the other group. Further, the intra-articular infiltration-instillation significantly reduced blood loss through the drain, the requirement of postoperative blood transfusions, and the duration of hospital stay. Conclusions It can be safely concluded that ropivacaine cocktail and tranexamic acid instillation postoperatively in knee arthroplasty patients is a very useful and effective technique to reduce postoperative pain and blood loss.

Abstract

BACKGROUND Some studies have recommended combining germinal matrix excision with phenol ablation in the treatment of onychocryptosis. Matrixectomy after phenolization has been shown to be an effective modification to reduce the drawbacks associated with phenolization alone, although it increases the risk of minor postoperative bleeding. The present study aims to assess the effectiveness and safety of gelatin sponges as hemostatic agents in partial matrixectomy after phenolization. METHODS A comparative clinical trial in parallel groups was designed in 74 halluces (44 patients) with stage I, II, and III onychocryptosis. All participants were randomly assigned to 3 groups: Group A (control group), Group B (conventional gelatin sponge), and Group C (high porosity gelatin sponge). RESULTS The quantified mean blood loss in the first 48 h after surgery in patients in both experimental groups was significantly lower compared to the control group. The lowest mean blood loss was recorded in Group C (p < 0.001) and followed by Group B (p = 0.005). No adverse effects were recorded in any of the patients included in the experimental groups. CONCLUSIONS Hemostatic gelatin sponges were demonstrated to be effective and safe devices for the control of minor postoperative bleeding associated with matrixectomy after segmental phenolization.

Abstract

OBJECTIVE To evaluate the clinical efficacy of intralesional platelet-rich plasma (PRP) injections compared to intralesional triamcinolone acetonide (TA) injections in the treatment of erosive oral lichen planus (EOLP). MATERIAL AND METHODS Twenty patients with EOLP were assigned randomly to either PRP or TA group. Patients received weekly intralesional injections for 4 weeks, and then followed up for 3 months on regular visits every 2 weeks. Pain scores using numerical pain score and clinical score were recorded by a blinded assessor each visit for all patients and remission score at the end of the trial was recorded. RESULTS Both groups showed significant improvement in the clinical parameters (pain and clinical score) "p = .001." Regarding remission of the lesions, 80% of patients in the PRP group showed complete remission compared to 70% in the TA group. However, there is no statistical significance when comparing the two groups in pain score, clinical score, or remission. CONCLUSIONS PRP injections could be considered as an effective alternative single treatment modality for EOLP. The protocol for this study registered in Clinicaltrials.gov registry under the identifier number: NCT03293368.

Abstract

AIMS AND OBJECTIVES To measure the additional effect of platelet-rich plasma (PRP) on functional outcome of anterior cruciate ligament tear managed by augmenting anterior cruciate ligament (ACL) reconstruction with PRP. METHODS The present study was conducted on patients with ACL tear admitted in the department of orthopaedics, King George's Medical University, Lucknow wherein a total of 70 subjects were assigned into two groups of 35 patients each randomly, viz Group 1 in which the patients were treated by quadruple hamstring graft alone and Group 2 in which the patients were treated with augmented hamstring graft with PRP. The standardized anterior drawer test, Lachman's test, Lysholm knee score were quantified both preoperatively and postoperatively at different follow-ups and also tibial tunnel widening was measured postoperatively at different follow-ups. RESULT The present study had 70 patients with ACL tears. The mean age of patients in non-PRP groups was 29.71 ±2.99 years while that in the PRP group was 28.34±4.32 years. On comparing the improvement in grades at pre-op, immediate postop, 6 weeks, and 3 months follow-ups, there was no statistically significant difference between the two groups. The tibial tunnel widening also showed no significant difference between the two groups. CONCLUSION In our study, it was found that both the groups showed improvements in grades of anterior drawer test and Lachman's test postoperatively but the difference between both the groups was not significant. Similarly, while comparing the improvements in Lysholm knee score and tibial tunnel widening among both the groups, the difference was not significant. Follow up of 3 months was a limiting factor in our study. This technique needs further clinical evaluation to assess the long-term results.

Abstract

CONTEXT Status of bone-implant interface or osseointegration can be assessed by using resonance frequency analysis (RFA), which measures implant stability. A modified implant surface can significantly enhance osseointegration and reduce healing period. Platelet-rich fibrin (PRF) consists of fibrin mesh with entrapped platelets and leukocytes that release a huge number of growth factors which contribute to wound healing and tissue regeneration. AIMS The present study aims to evaluate the effect of PRF on osseointegration in terms of implant stability. SETTINGS AND DESIGN This was a split-mouth randomized clinical trial. MATERIALS AND METHODS Sixty surgical sites were divided randomly into two groups. In Group 1 (thirty sites), PRF was placed in osteotomy sites before implant placement whereas no PRF was placed in Group 2 (thirty sites). Stability was measured using RFA in terms of implant stability quotient (ISQ) at baseline, 1 week, 1 month, and 3 months. STATISTICAL ANALYSIS Intergroup comparison was done using Mann-Whitney U-test. Intragroup comparison was done using Friedman's test followed by pairwise comparison using Wilcoxon signed-rank test. RESULTS On intergroup comparison, Group 1 showed higher values for ISQ which were statistically significant (P < 0.05) at 1 week and 1 month. No significant difference (P > 0.05) was found at baseline and 3 months. Intragroup comparison and further pairwise comparison revealed a highly significant difference for values between all pairs of time intervals (P < 0.01) with higher values at 3 months. CONCLUSIONS PRF has a significant effect on osseointegration of dental implants during the early healing period prior to loading.

Abstract

Background Total knee replacement (TKR) is an artificial joint surgical procedure that replaces the damaged articular surfaces of the knee joint. Despite several studies on the efficacy of intra-articular and intravenous Tranexamic acid (TX) use in reducing blood loss following TKR, the route of TXA administration is still an ongoing topic of debate. Our study aimed to compare total knee replacement efficacy (hemoglobin level, hematocrit level, hospital stay, and complications) of intra-articular and intravenous tranexamic acid administration. Material and Methods A Prospective study was conducted at the Department of Orthopedics, Shifa International Hospital, Islamabad. The study duration was six months (August 2020 to February 2021). A sample size of 60 patients was calculated using the WHO calculator. Patients were selected through non-probability consecutive sampling. Patients were randomly divided into two groups; Group A was given intraarticular TXA, while group B was given intra-venous TXA following total knee replacement. Patients were followed for 48 hours. Data were analyzed using SPSS version 24. An Independent T-test was applied, and a P value≤0.05 was considered significant. Results A total of 60 patients were included in the study. There were 20 (33.3%) male and female 40 (66.7%). The mean age of patients was 64.4±10.8SD. Post-operative hemoglobin level in group A was 11.09±0.39SD, and in group B was 9.93±1.73SD (p=0.03). Postoperatively, the mean HCT level in group A was 30.53±4.26SD and group B 26.88±5.48SD (p=0.01). Conclusion Intra-articular administration of TXA is more effective than intravenous administration in controlling postoperative blood loss following total knee replacement.

Abstract

PURPOSE To find the best short-term daily recombinant human erythropoietin (rhEPO)-based treatment protocols for blood-saving purpose in THA. METHOD The patients were randomized to 1 of 3 interventions: Patients in group A received 10,000 IU (150 IU/kg) of subcutaneous rhEPO (1 ml) daily from 5 days preoperatively to 3 days postoperatively (9 doses in total); Patients in group B received 1 ml of subcutaneous normal saline daily from 5 days preoperatively to 3 days preoperatively and then 10,000 IU (150 IU/kg) of subcutaneous rhEPO daily until 3 days postoperatively (6 doses in total). Patients in group C received 1 ml of subcutaneous normal saline daily from 5 days preoperatively to one day preoperatively and then 10,000 IU (150 IU/kg) of subcutaneous rhEPO daily from the day of surgery to 3 days postoperatively (4 doses in total). RESULTS One hundred eighty patients were included. On postoperative day one, patients in the group A showed significantly higher Hb level (108.4 ± 11.4 g/L) than group C (103.9 ± 8.8 g/L). Group B (107.8 ± 8.4 g/L) also showed significantly higher Hb level than group C (103.9 ± 8.8 g/L) (p < 0.05). On postoperative day 3, no significant difference was found between group B and group C in Hb level (98.7 ± 10.5 and 94.9 ± 8.7 g/L, respectively) (p = 0.094), but the Hb level in group A (103.6 ± 11.0 g/L) was still markedly higher than in group B and the Hb level in group A was also markedly higher than in group C. In terms of blood loss, no markedly difference was found in intraoperative blood loss among group A, B and C (78.3 ± 22.4, 84.6 ± 29.1, and 80.3 ± 23.9 ml, respectively) (p = 0.381), but on postoperative day one, the mean blood loss in group C (522.4 ± 189.4 ml) was significantly more than group B (371.2 ± 124.6 ml), and group B was also significantly more than group A (284.8 ± 112.9 ml) with 95% confidence interval, and group B had significantly less blood loss than group C (p < 0.001). With respect to the total blood loss, the total blood loss in group C (881.6 ± 314.9 ml) was significantly more than group B (642.6 ± 232.9 ml), and group B was also significantly more than group A (514.5 ± 204.6 ml) with 95% confidence interval (Table 2). Only 2 patients in each group received allogeneic blood transfusion and each patient received 2 units of red blood cells, so, the transfusion requirements among the three groups were comparable. CONCLUSIONS Daily small-dose of subcutaneous rhEPO administered from 5 days before THA could significantly decrease perioperative blood loss and improve postoperative Hb levels, without increasing risks of complications, when compared with the application of rhEPO from 3 days before THA or from the day of surgery. However, surgeons should choose the regimen individually according to different patients' personal circumstances.