Introduction. The ACTIVE(Advanced Cartilage Treatment with Injectable-hydrogel Validation of the Effect) study investigates safety and performance of a novel dextran-tyramine hydrogel implant for treatment of small cartilage defects in the knee (0.5-2.0cm2). The hydrogel is composed of a mixture of natural polymer conjugates that are mixed intra-operatively and which cross-link in situ through a mild enzymatic reaction, providing a cell-free scaffold for cartilage repair. Method. The ACTIVE study is split into a safety (n=10) and a performance cohort (n=36). The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), Short-Form Health Survey (SF-36) were compared at baseline and 3, 6, and 12 months after surgery. The primary performance hypothesis is an average change in the KOOS from baseline to 12 months (ΔKOOS) greater than a minimal clinically important change (MIC) of 10. No statistical tests were performed as these are preliminary data on a smaller portion of the total study. Result. All patients of the safety cohort (n=10, mean age±SD, 30±9 years) were treated with the hydrogel for a symptomatic (NRS≥4) cartilage defect on the femoral condyle or trochlear groove (mean size±SD, 1.2±0.4cm2). No signs of an adverse foreign tissue reaction or serious adverse events were recorded within the safety cohort. At final follow-up mean KOOS±SD was 66.9±23.5, mean NRS resting±SD was 1.3±1.9, NRS activity±SD was 3.8±2.9 and mean SF-36±SD was 72.0±10.9. ΔKOOS was 21. One patient sustained new knee trauma prior to final follow-up, affecting final scores considerably. When excluded, ΔKOOS was 24(n=9). Conclusion. These promising initial findings provide a solid basis for continuation and expansion of this unique cartilage treatment. The MIC of 10 was surpassed. Though, results should be interpreted cautiously as they are based solely on preliminary data of the first 10 patients. Acknowledgements. Study is sponsored by Hy2Care, producer of the CartRevive®(dextran-tyramine) Hydrogel implant

Aims. Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach. Methods. A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications. Results. A total of 19 studies were included: four one-stage, 14 two-stage, and one article with both one- and two-stage groups. Superficial infection was the most common complication (one-stage: 38% vs two-stage: 52%). There was a notable difference in the incidence of osteomyelitis (one-stage: nil vs two-stage: 10%) and implant failure (one-stage: 1% vs two-stage: 9%). Fracture incidence was equivocal (one-stage: 13% vs two-stage: 12%), and comparison of soft-tissue, stoma, and mechanical related complications was not possible. Conclusion. This review suggests that the one-stage approach is favourable compared to the two-stage, because the incidence of complications was slightly lower in the one-stage cohort, with a pertinent difference in the incidence of osteomyelitis and implant failure. Cite this article: Bone Jt Open 2023;4(7):539–550

Aims. This study aimed to evaluate whether an enhanced recovery protocol (ERP) for arthroplasty established during the COVID-19 pandemic at a safety net hospital can be associated with a decrease in hospital length of stay (LOS) and an increase in same-day discharges (SDDs) without increasing acute adverse events. Methods. A retrospective review of 124 consecutive primary arthroplasty procedures performed after resuming elective procedures on 11 May 2020 were compared to the previous 124 consecutive patients treated prior to 17 March 2020, at a single urban safety net hospital. Revision arthroplasty and patients with < 90-day follow-up were excluded. The primary outcome measures were hospital LOS and the number of SDDs. Secondary outcome measures included 90-day complications, 90-day readmissions, and 30day emergency department (ED) visits. Results. The mean LOS was significantly reduced from 2.02 days (SD 0.80) in the pre-COVID cohort to 1.03 days (SD 0.65) in the post-COVID cohort (p < 0.001). No patients in the pre-COVID group were discharged on the day of surgery compared to 60 patients (48.4%) in the post-COVID group (p < 0.001). There were no significant differences in 90-day complications (13.7% (n = 17) vs 9.7% (n = 12); p = 0.429), 30-day ED visits (1.6% (n = 2) vs 3.2% (n = 4); p = 0.683), or 90-day readmissions (2.4% (n = 3) vs 1.6% (n = 2); p = 1.000) between the pre-COVID and post-COVID groups, respectively. Conclusion. Through use of an ERP, arthroplasty procedures were successfully resumed at a safety net hospital with a shorter LOS and increased SDDs without a difference in acute adverse events. The resulting increase in healthcare value therefore may be considered a ‘silver lining’ to the moratorium on elective arthroplasty during the COVID-19 pandemic. These improved efficiencies are expected to continue in post-pandemic era. Cite this article: Bone Jt Open 2021;2(10):871–878

In-office surgeries have the potential to offer high quality medical care in a more efficient, cost-effective setting than outpatient surgical centers for certain procedures. The primary concerns with operating on patients in the office setting are insufficient sterility and lack of appropriate resources in case of excessive bleeding or other surgical complications. This study serves to investigate these concerns and determine whether in-office hand surgeries are safe and clinically effective. A retrospective review of patients who underwent minor hand operations in the office setting between December 2020 and December 2021 was performed. The surgical procedures included in this analysis are needle aponeurotomy, trigger finger release, mass/foreign body removal and reduction of hand/wrist fracture with or without percutaneous pinning. No major complications requiring extended observation or hospital admission occurred. 122 of the 132 patients (92.4%) were successfully treated with no complications and only mild symptoms within one month of surgery. Five patients (3.8%) returned to the office for pain, inflammation and/or stiffness of the affected finger, with two of the five returning due to osteoarthritis and/or pseudogout flare-ups. Five additional patients returned due to incomplete treatment with continued presence of Dupuytren's contracture (3), trigger finger (1) or infected foreign body (1). One patient (0.8%) developed infection, due to incomplete removal of an infected foreign body, which was subsequently treated with antibiotics and complete foreign body removal. The absence of major complications and high success rate for minor hand procedures shows the high degree of safety and efficacy which can be achieved via the in-office setting for select procedures. While proper patient selection is key, our result shows the in-office procedure room setting can offer the necessary elements of sterility and hemostatic support for several common hand surgeries

In patients admitted to hospital with a hip fracture, urinary issues are common. Despite guidelines that recommend avoiding foley catheter usage when possible, it remains a common part of perioperative care. To date, there is no prospective data on the safety and satisfaction associated with catheter use in such cohort. The aim of this study was to evaluate the satisfaction of patients when using a foley catheter while they await surgery for their fractured hip and the safety associated with catheter use. In our prospectively collected database, 587 patients were admitted to our tertiary care center over a 1 year period. Most patients (328) were catheterized within the first 24h of admission, primarily inserted in ED. Of these patients, 119 patients (61 catheterized and 58 noncatheterized) completed a questionnaire about their perioperative management with foley catheter usage administered on day 1 of admission. This was used to determine satisfaction of catheter use (if catheterized) and pain levels (associated with catheterized or associated with transferring/voiding if not catheterized). Adverse effects related with catheter use included urinary tract infection (UTI) and post-operative urinary retention (POUR). Ninety-five percent of patients found the catheter to be convenient. Only 5% of patients reported any pain with catheter use. On the contrary, 47.5% of non-catheterized patients found it difficult to move to the bathroom and 30.4% found it difficult to urinate. Catheterized patients had significative less pain than uncatheterized patients (0.62/10 vs 2.45/10 respectively, p < 0 .001). The use of nerve block reduced pain levels amongst catheterized patients but was not associated with reduced pain levels or satisfaction amongst non-catheterized patients. The use of catheter was not associated with increased risk of UTI(17.5% in the catheterized vs 13.3% in the non-catheterized, p = 0.541) or POUR (6.8% in the catheterized vs 11.1% in the non-catheterized, p = 0.406). This study illustrates the benefits and safety associated with the use of urinary catheters in the pre-operative period amongst hip fractures. The use of catheters was associated with reduced pain and satisfaction without increasing post-operative UTI or POUR. These findings suggest that pre-operative catheter use is associated with less pain and more satisfaction for patients awaiting hip surgery and whom other measures, such as nerve blocks, are unlikely to reduce the discomfort associated with the mobility required to void. A prospective randomized control study could lead to a more evidence based approach for perioperative foley catheter usage in hip fracture patients

Aims. The efficacy and safety of intrawound vancomycin for preventing surgical site infection in primary hip and knee arthroplasty is uncertain. Methods. A systematic review of the literature was conducted, indexed from inception to March 2020 in PubMed, Web of Science, Cochrane Library, Embase, and Google Scholar databases. All studies evaluating the efficacy and/or safety of intrawound vancomycin in patients who underwent primary hip and knee arthroplasty were included. Incidence of periprosthetic joint infection (PJI), superficial infection, aseptic wound complications, acute kidney injury, anaphylactic reaction, and ototoxicity were meta-analyzed. Results were reported as odds ratios (ORs) and 95% confidence intervals (CIs). The quality of included studies was assessed using the risk of bias in non-randomized studies of interventions (ROBINS-I) assessment tool. Results. Nine studies involving 4,607 patients were included. Intrawound vancomycin was associated with lower incidence of PJI (30 patients (1.20%) vs 58 control patients (2.75%); OR 0.44, 95% CI 0.28 to 0.69) and simultaneous acute kidney injury (four patients (0.28%) vs four control patients (0.35%), OR 0.71, 95% CI 0.19 to 2.55). However, it did not reduce risk of superficial infection (four patients (0.67%) vs six control patients (1.60%), OR 0.60, 95% CI 0.17 to 2.12) and was associated with higher incidence of aseptic wound complications (23 patients (2.15%) vs eight in control patients (0.96%), OR 2.39, 95% CI 1.09 to 5.23). Four studies reported no anaphylactic reactions and three studies reported no ototoxicity in any patient group. Conclusion. The current literature suggests that intrawound vancomycin used in primary hip and knee arthroplasty may reduce incidence of PJI, but it may also increase risk of aseptic wound complications. Cite this article: Bone Joint Res 2020;9(11):778–788

Introduction. Day stay surgery for anterior cruciate ligament (ACL) reconstructions is an increasingly common practice and has driven clinicians to come up with postoperative pain regimes that allow same day mobilisation and a safe and timely discharge. There is a paucity of literature surrounding the use of intraosseous (IO) ropivacaine used as a Bier's block to provide both intraoperative and postoperative analgesia in lower limb surgery. Methods. This patient blinded, pilot study randomised 15 patients undergoing ACL reconstruction to receive either IO ropivacaine 1.5 or 2.0 mg/kg; or 300 mg of ropivacaine as local infiltration (standard of care). Toxic plasma levels of ropivacaine have been defined in the literature and therefore the primary outcome for this study was arterial plasma concentration of ropivacaine as a means to determine its safety profile. Samples were taken via an arterial line at prespecified times after tourniquet deflation. Secondary outcomes that we were interested in included immediate postoperative pain scores using the visual analogue scale (VAS) and perioperative opioid equivalent consumption. Results. Participants had a mean age of 27.8 (SD 9.2) years and 87% (13/15) were male. All patients in the intervention group receiving IO ropivacaine had plasma concentrations well below the threshold for central nervous system (CNS) toxicity (0.60 µg/ml). The highest plasma concentration was achieved in the intervention group receiving 1.5 mg/kg dose of ropivacaine reaching 3.59 mg/ml. This would equate to 0.22 µg/ml of free plasma ropivacaine. There were no differences across the three groups regarding pain scores or perioperative opioid consumption. Conclusions. This study demonstrates that IO administration of 0.2% ropivacaine is both safe and effective in reducing perioperative pain in patients undergoing ACL reconstruction. There may be scope to increase the IO dose further or utilise other analgesics via the IO regional route to improve perioperative pain relief

Introduction. Low back pain (LBP) is a worldwide leading cause of disability. This preclinical study evaluated the safety of a combined advanced therapy medicinal product developed during the European iPSpine project (#825925) consisting of mesendoderm progenitor cells (MEPC), derived from human induced pluripotent stem cells, in combination with a synthetic poly(N-isopropylacrylamide) hydrogel (NPgel) in an ovine intervertebral disc degeneration (IDD) model. Method. IDD was induced through nucleotomy in 4 adult sheep, 5 lumbar discs each (n=20). After 5 weeks, 3 alternating discs were treated with NPgel (n=6) or NPgel+MEPC (n=6). Before sacrifice, animals were subjected to: MRI of lumbar spines (disc height and Pfirmann grading); blood sampling (hematological, biochemical, metabolic and lymphocyte/monocytes immunological). After 3 months the sheep were sacrificed. The spines were processed for: macroscopic morphology (Thompson grading), microscopic morphology (Histological grading), and glycosaminoglycan content (GAG, DMMB Assay). Furthermore, at sacrifice biodistribution of human MEPC was assessed by Alu-sequences quantification (qPCR) from three tissue samples of heart, liver, spleen, brain, lungs, and kidneys, and PBMCs collected to assess activation of systemic immune cells. To each evaluation, appropriate statistical analysis was applied. Result. Flow cytometry showed no induction of systemic activation of T cells or monocytes. Alu quantification did not give detection of any cells in any organ. Disc height index was slightly increased in discs treated with NPgel+MEPC. Pfirmann's and Thompson's classification showed that treatment with NPgel or NPgel+MEPC gave no adverse reactions. Histological grading showed similar degeneration in vertebrae treated with NPgel+MEPC or with NPgel alone. The amount of GAG was significantly increased in the nucleus pulposus following treatment with NPgel+MEPC compared to NPgel alone, in which a decrease was observed compared to untreated discs in both nucleus pulposus and annulus fibrosus. Conclusion. This study showed the safety of both NPgel+MEPC and NPgel treatments

Aims. The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease. Methods. A systematic search was performed on PubMed, EMBASE, the Cochrane Library, MEDLINE, China National Knowledge Infrastructure (CNKI), and WANFANG for randomized controlled trials (RCTs) that investigated the safety and accuracy of RA compared with conventional freehand with/without fluoroscopy-assisted pedicle screw insertion for spine disease from 2012 to 2019. This meta-analysis used Mantel-Haenszel or inverse variance method with mixed-effects model for heterogeneity, calculating the odds ratio (OR), mean difference (MD), standardized mean difference (SMD), and 95% confidence intervals (CIs). The results of heterogeneity, subgroup analysis, and risk of bias were analyzed. Results. Ten RCTs with 713 patients and 3,331 pedicle screws were included. Compared with CT, the accuracy rate of RA was superior in Grade A with statistical significance and Grade A + B without statistical significance. Compared with CT, the operating time of RA was longer. The difference between RA and CT was statistically significant in radiation dose. Proximal facet joint violation occurred less in RA than in CT. The postoperative Oswestry Disability Index (ODI) of RA was smaller than that of CT, and there were some interesting outcomes in our subgroup analysis. Conclusion. RA technique could be viewed as an accurate and safe pedicle screw implantation method compared to CT. A robotic system equipped with optical intraoperative navigation is superior to CT in accuracy. RA pedicle screw insertion can improve accuracy and maintain stability for some challenging areas. Cite this article: Bone Joint Res 2020;9(10):653–666

Patients undergoing total hip or knee arthroplasty (THA/TKA) are commonly associated with high pain scores and narcotic use. Duloxetine is effective in relieving chronic pain. The aim of this study was to evaluate the safety and efficacy of duloxetine for pain management following THA/TKA. Five major databases (PubMed, Embase, Scopus, Cochrane, and Web of Science) were searched for randomised controlled trials (RCTs) that compared duloxetine to placebo in patients that underwent THA/TKA. The primary outcome was pain reduction with rest and movement at short-term and long-term time intervals. Secondary outcomes were the use of analgesics, length of stay, and safety profile. The risk of bias was assessed using the Cochrane tool. Data were pooled using RevMan 5.4. The results were reported as mean difference (MD) or standardised MD (SMD) and 95% confidence intervals (CI). Eight RCTs with 767 patients were included. 50.2% (n=385/767) of patients received duloxetine. After one day, duloxetine was superior to the control regarding pain reduction with rest (SMD= −0.22 [−0.41, −0.03], p=0.02) after sensitivity analysis and pain reduction at movement (SMD= −0.39 [−0.55, −0.24], p<0.001). Similarly, after 12 weeks, duloxetine significantly reduced pain with rest (SMD= −0.3 [−0.52, −0.09], p=0.006) and pain with movement (SMD= −0.52 [−0.87, −0.17], p=0.003). In addition, after sensitivity analysis, duloxetine was associated with less analgesic use after one day (MD= −4.65 [−7.3, −2.01], p<0.001) and two days (MD= −5.65 [−10.62, −0.67], p=0.03). Patients who received duloxetine also required fewer analgesics after three days. However, there was no significant difference between the duloxetine and control groups in analgesic use after one week, length of stay, and adverse events. Duloxetine was superior to the placebo regarding short-term and long-term pain reduction with rest and movement following THA/TKA. Duloxetine reduced postoperative analgesic use. There was no significant difference between duloxetine and placebo regarding adverse events and length of stay

Ceramic bearing fractures are rare events, but mandate revision and implantation of new bearings. Revisions using metal heads have been reported to lead to gross volumetric head wear (due to abrasive retained ceramic micro-debris), cobalt toxicity, multi-organ failure and death. Such complications are widely published (50+ reports), yet we know that patients continue to be put at risk. Using data from the NJR and AOANJRR, this study seeks to compare the risk of re-revision and death by revision bearing combination following a ceramic bearing fracture. Data were extracted from the NJR and AOANJRR, identifying revisions for ceramic bearing fracture. Subsequent outcomes of survival, re-revision and death were compared between revision bearing combinations (ceramic-on-ceramic, ceramic-on-polyethylene, and metal-on-polyethylene). 366 cases were available for analysis from the NJR dataset (MoP=34, CoP=112, CoC=221) and 174 from the AOANJRR dataset (MoP=17, CoP=44, CoC=113). The overall incidence rate of adverse outcome (revision or death) was 0.65 for metal heads and 0.23 for ceramic head articulations (p=0.0012) across the whole time period (NJR). Kaplan-Meir survival estimates demonstrate an increased risk of both re-revision and death where a metal head has been used vs a ceramic head following revision for ceramic fracture. There are few decisions in arthroplasty surgery that can lead to serious harm or death for our patients, but revision using a metal head following ceramic bearing fracture is one of them. This study enhances the signal of what is already known but previously only reported as inherently low-level evidence (case reports and small series) due to event rarity. Use of a metal head in revision for ceramic fracture represents an avoidable patient safety issue, which revision guidelines should seek to address

Aims. To evaluate safety outcomes and patient satisfaction of the re-introduction of elective orthopaedic surgery on ‘green’ (non-COVID-19) sites during the COVID-19 pandemic. Methods. A strategy consisting of phased relaxation of clinical comorbidity criteria was developed. Patients from the orthopaedic waiting list were selected according to these criteria and observed recommended preoperative isolation protocols. Surgery was performed at green sites (two local private hospitals) under the COVID-19 NHS contract. The first 100 consecutive patients that met the Phase 1 criteria and underwent surgery were included. In hospital and postoperative complications with specific enquiry as to development of COVID-19 symptoms or need and outcome for COVID-19 testing at 14 days and six weeks was recorded. Patient satisfaction was surveyed at 14 days postoperatively. Results. There were 54 females and 46 males (mean age 44 years, mean body mass index (BMI) 25.6 kg/m. 2. ). In all, 56 patients underwent major orthopaedic procedures. There were no exclusions. One patient had a postoperative positive SARS-CoV-2 RT-PCR test but had no typical symptoms of COVID-19 infection and no clinical sequelae. 99% of patients were satisfied with the process and 98% would recommend undergoing elective orthopaedic surgery in the study period. Conclusion. In an environment with appropriate infrastructure, patient selection, isolation, screening, and testing, elective orthopaedic surgery is safe during the COVID-19 pandemic, and associated with high patient satisfaction. Further follow-up is required to establish that safety is maintained as the clinical restrictions are eased with the phased approach described. Cite this article: Bone Joint Open 2020;1-8:450–456

Aims. The optimum type of antibiotics and their administration route for treating Gram-negative (GN) periprosthetic joint infection (PJI) remain controversial. This study aimed to determine the GN bacterial species and antibacterial resistance rates related to clinical GN-PJI, and to determine the efficacy and safety of intra-articular (IA) antibiotic injection after one-stage revision in a GN pathogen-induced PJI rat model of total knee arthroplasty. Methods. A total of 36 consecutive PJI patients who had been infected with GN bacteria between February 2015 and December 2021 were retrospectively recruited in order to analyze the GN bacterial species involvement and antibacterial resistance rates. Antibiotic susceptibility assays of the GN bacterial species were performed to screen for the most sensitive antibiotic, which was then used to treat the most common GN pathogen-induced PJI rat model. The rats were randomized either to a PJI control group or to three meropenem groups (intraperitoneal (IP), IA, and IP + IA groups). After two weeks of treatment, infection control level, the side effects, and the volume of antibiotic use were evaluated. Results. Escherichia coli was the most common pathogen in GN-PJI, and meropenem was the most sensitive antibiotic. Serum inflammatory markers, weightbearing activity, and Rissing score were significantly improved by meropenem, especially in the IA and IP + IA groups ( p < 0.05). Meropenem in the IA group eradicated E. coli from soft-tissue, bone, and prosthetic surfaces, with the same effect as in the IP + IA group. Radiological results revealed that IA and IP + IA meropenem were effective at relieving bone damage. Haematoxylin and eosin staining also showed that IA and IP + IA meropenem improved synovial inflammation and bone destruction. No pathological changes in the main organs or abnormal serum markers were observed in any of the meropenem-treated rats. The IA group required the lowest amount of meropenem, followed by the IP and IP + IA groups. Conclusion. IA-only meropenem with a two-week treatment course was effective and safe for PJI control following one-stage revision in a rat model, with less meropenem use. Cite this article: Bone Joint Res 2024;13(10):546–558

The trapeziometacarpal joint (TMCJ) is the most common hand joint affected by osteoarthritis (OA), and trapezium implant arthroplasty is a potential treatment for recalcitrant OA. This meta-analysis aimed to investigate the efficacy and safety of various trapezium implants as an interventional option for TMCJ OA. Web of Science, PubMed, Scopus, Google Scholar, and Cochrane library databases were searched for relevant studies up to May 2022. Preferred Reported Items for Systematic Review and Meta-Analysis guidelines were adhered to and registered on PROSPERO. The methodological quality was assessed by National Heart, Lung, and Blood Institute tools for observational studies and the Cochrane risk of bias tool. Subgroup analyses were performed on different replacement implants, the analysis was done via Open Meta-Analyst software and P values < 0.05 were considered statistically significant. A total of 123 studies comprising 5752 patients were included. Total joint replacement (TJR) implants demonstrate greater significant improvements in visual analogue scale pain scores postoperatively. Interposition with partial trapezial resection implants was associated with the highest grip strength and highest reduction in the Disabilities of the Arm, Shoulder, and Hand score. Revision rates were highest in TJR (12.3%), and lowest in interposition with partial trapezial resection (6.2%). Total joint replacement and interposition with partial trapezial resection implants improve pain, grip strength, and DASH scores more than other implant options. Future studies should focus on high-quality randomized clinical trials comparing different implants to accumulate higher quality evidence and more reliable conclusions

Use of ultrasonic bone scalpel (UBS) is becoming popular in spinal surgery. This study presents the safety profile of UBS for posterior release in surgical correction of adolescent idiopathic scoliosis (AIS). From 2016 to 2018, UBS (Misonix) was used by the senior author in a variety of spinal operations. Data for intraoperative complications when this devise was used for posterior correction of AIS were collected. Revision cases were excluded. UBS was used for posterior release of AIS in 65 patients (58 female, seven male) with an average age of 15.6 years (range 11–23). Average length of posterior instrumentation was 12 levels (range 6–14). Instrumentation was exclusively from T2 to L4. To achieve adequate release for correction, UBS was used to perform a total of 644 modified in-situ chevron osteotomies (average ten, range six to 12) and 31 rib osteotomies. Overall, three complications (4.6 %) were directly related to the use of UBS: one haemopneumothorax, which was successfully treated with a chest drain; and two loss of motor-evoked potentials during monitoring, which led to the postponement of the final correction. These two patients did not have any neurological problems and their surgery was completed successfully within 1 week of the initial surgery. One late deep infection was reported. This was not thought to be directly related to the use of UBS. Use of UBS in the posterior surgical treatment of AIS appears to be relatively safe with a low level of acceptable complications. However, appropriate training is required for the use of UBS

The posterior compartments of the knee are currently accessed arthroscopically through anterior, posteromedial or posterolateral portals. A direct posterior portal to access the posterior compartments has been overlooked due to a perceived high-risk of injury to the popliteal neurovascular structures. Therefore, this study aimed to investigate the safety and accessibility of a direct posterior portal into the knee. This cross-sectional study comprised a sample of 95 formalin-embalmed cadaveric knees and 9 fresh-frozen knees. Cannulas were inserted into the knees, 16mm from the vertical plane between the medial epicondyle of the femur and medial condyle of the tibia and 8 and 14mm (females and males respectively) from the vertical plane connecting the lateral femoral epicondyle and lateral tibial condyle. Landmarks were identified in full extension and cannula insertion was completed with the formalin-embalmed knees in full extension and the fresh-frozen in 90-degree flexion. Posterior aspects of the knees were dissected from superficial to deep, to assess potential damage caused by cannula insertion. Incidence of neurovascular damage was 9.6% (n=10); 0.96% medial cannula and 8.7% lateral cannula. The medial cannula damaged one small saphenous vein (SSV) in a male specimen. The lateral cannula damaged one SSV, 7 common fibular nerves (CFN) and both CFN and lateral cutaneous sural nerve in one specimen. All incidences of damage occurred in formalin-embalmed knees. The posterior horns of the menisci were accessible in all specimens. A medial-lying direct posterior portal into the knee is safe in 99% of occurrences. The lateral-lying direct posterior portal is of high risk to the CFN

Aim. Antimicrobial peptides occur naturally in our intrinsic immune system. PLG0206 is a novel, engineered, 24-amino acid peptide which has broad-spectrum antimicrobial activity, including in biofilm and against multi-drug resistant pathogens (1,2). This is the first clinical study to evaluate the safety and tolerability of PLG0206 when administered via an irrigation solution in patients with periprosthetic joint infections (PJI) following total knee arthroplasty (TKA) during debridement, antibiotics, and implant retention (DAIR). Secondary objectives were to evaluate pharmacokinetics (PK), biomarkers and initial clinical efficacy at one year post-DAIR procedure. Method. This prospective, multicenter, open-label, interventional study assessed two dose levels of PLG0206. Fourteen patients underwent revision for PJI after TKA. At the end of debridement, they received a single intra-articular irrigation of PLG0206 into the wound cavity lasting 15 minutes at concentrations of 3 mg/mL (n=7) or 10 mg/mL (n=7). Patients received post-operative care and intravenous/oral antimicrobial therapy as per their institutional guidelines. Patients were monitored for safety and signs of relapse or persistent infection for 12 months post study drug administration and PK and blood biomarkers were assessed. Results. All patients completed their final study assessment at Day 365. Over the 1-year follow-up, only one recurrence (7%) was noted at Day 169 in the low-dose cohort. Following dosing, nine patients (64.3%) had limited systemic exposure; maximum plasma concentration occurred 1-hour post-administration and declined rapidly to undetectable levels by 24 hours following treatment in all patients. The incidence of drug related treatment-emergent adverse events (TEAEs) was low. Two patients, both in the higher dose cohort, experienced a transient drug related TEAE; one of hypertransaminasaemia and one of neuralgia. Both events were moderate in severity and resolved within two weeks of onset. Conclusions. A single 15-minute irrigation of PLG0206 into the wound cavity of patients undergoing a DAIR procedure for PJI following TKA, is safe and well tolerated by patients. This new antimicrobial peptide offers a promising therapeutic option in musculoskeletal infection. The initial clinical efficacy is encouraging but now needs to be investigated in a much larger clinical trial

Objectives. Osteoporosis has become an increasing concern for older people as it may potentially lead to osteoporotic fractures. This study is designed to assess the efficacy and safety of ten therapies for post-menopausal women using network meta-analysis. Methods. We conducted a systematic search in several databases, including PubMed and Embase. A random-effects model was employed and results were assessed by the odds ratio (OR) and corresponding 95% confidence intervals (CI). Furthermore, with respect to each outcome, each intervention was ranked according to the surface under the cumulative ranking curve (SUCRA) value. Results. With respect to preventing new vertebral fractures (NVF), all ten drugs outperformed placebo, and etidronate proved to be the most effective treatment (OR 0.24, 95% CI 0.14 to 0.39). In addition, zoledronic acid and parathyroid hormone ranked higher compared with the other drugs. With respect to preventing clinical vertebral fractures (CVF), zoledronic acid proved to be the most effective drug (OR = 0.25, 95% CI 0.08 to 0.92), with denosumab as a desirable second option (OR = 0.48, 95% CI 0.22 to 0.96), when both were compared with placebo. As for adverse events (AE) and severe adverse events (SAE), no significant difference was observed. According to SUCRA, etidronate ranked first in preventing CVF; parathyroid hormone and zoledronic acid ranked highly in preventing NVF and CVF. Raloxifene was safe with a high rank in preventing AEs and SAEs though performed unsatisfactorily in efficacy. Conclusions. This study suggests that, taking efficacy and safety into account, parathyroid hormone and zoledronic acid had the highest probability of satisfactory performance in preventing osteoporotic fractures. Cite this article: G. Wang, L. Sui, P. Gai, G. Li, X. Qi, X. Jiang. The efficacy and safety of vertebral fracture prevention therapies in post-menopausal osteoporosis treatment: Which therapies work best? a network meta-analysis. Bone Joint Res 2017;6:452–463. DOI: 10.1302/2046-3758.67.BJR-2016-0292.R1

Aim. As the number of performed total hip arthroplasties (THA) and total knee arthroplasties (TKA) has increased over the years, revision surgeries are expected to increase as well. Revision surgeries are associated with a longer operating room time, prolonged length of stay (LOS), and more frequent complications. Postoperative hematomas are a major reason for wound healing disturbances and periprosthetic joint infections (PJI). We aimed to systematically assess the use and safety of a microporous polysaccharide hemosphere (MPH) in revision THA and TKA. We focused on the risk reduction of further revision surgeries in case of wound healing disorders and hematoma, transfusion of packed red blood cells (PRBC), loss of hemoglobin (hb) and mean LOS following the use of MPH. Method. Our prospective study includes 89 patients who underwent revision surgery after THA and TKA with application of MPH and were compared to 102 patients who did not receive MPH and underwent revision surgery after THA and TKA. Five grams of MPH. 1. were applied periarticular before fascia closure and to the subcutaneous soft tissue. The follow-up was conducted in daily clinical visits during the inpatient stay and three months postoperatively in our outpatient clinic. Repeated revision surgery was performed in case of prolonged secretion (>10 days) or clinical suspicion of infection. After matching the cohorts the outcomes were statistically analyzed using paired methods. Results. A significantly lower odds ratio for repeat revisions was found for the MPH cohort (OR=0.312; 95%-CI 0.090, 0.893; p=0.027). Differences between pre- and postoperative hb levels, LOS and transfusions of PRBC did not reach significance. No intra- or postoperative complications to MPH occurred. Moreover, no infection relapse occurred after applying MPH. Conclusions. Routine use of MPH in revision arthroplasty management after TKA and THA appears to be safe and an effective way to support hemostasis, with no observed adverse events related to MPH use. There were noticeably less hematomas and revision surgeries in the MPH group. 1. Arista BD, Franklin Lakes, NJ, USA

Abstract. Objective. To investigate the safety and cost-effectiveness of interscalene brachial plexus block/regional anaesthesia (ISB-RA) in patients undergoing reverse total shoulder replacement. Methods. This retrospective study included 15 patients with symptomatic rotator cuff arthropathy who underwent reverse total shoulder arthroplasty (rTSA) under ISB-RA without general anaesthesia in the beach chair position from 2010 to 2018. The mean patient age was 77 years (range 59–82 years). Patients had associated medical comorbidities: American Society of Anesthesiologists (ASA) grade 2–4. Assessed parameters were: duration of anaesthesia, intra-operative systolic blood pressure variation, sedation and vasopressor use, duration of post-operative recovery, recovery scores, length of stay, and complications. A robust cost analysis was also performed. Results. The mean (range) duration of anaesthesia was 38.66 (20–60) min. Maximum and minimum intra-operative systolic blood pressure ranges were 130–210 and 75–145 mmHg, respectively (mean [range] drop, 74.13 [33–125] mmHg). Mean (range) propofol dose was 1.74 (1–3.0) mg/kg/h. The Median (interquartile range) post-operative recovery time was 30 (20–50) min. The mean (range) postoperative recovery score (local scale, range 5–28 where lower values are superior) was 5.2 (5–8). The mean (range) length of stay was 8 (1–20 days); the two included patients with ASA grade 2 were both discharged within 24 hours. One patient with predisposing history developed pneumonia; however, there were no complications related to ISB-RA. The mean (range) cost per patient was £101.36 (£59.80-£132.20). Conclusions. Our data demonstrate that rTSA under ISB-RA is safe, cost-effective and a potentially viable alternative for patients with multiple comorbidities. Notably, patients with ASA grade 2 who underwent rTSA under ISB-RA had a reduced length of stay and were discharged within 24 hours