Adverse events (AEs) are still a major problem in spinal surgery, despite advances in surgical techniques, innovative technologies available and the introduction of checklist and predictive score systems aimed at reducing surgical complications. We previously analysed the results of the introduction of the WHO Safety Surgical Checklist (SSC) in our Institution, comparing the incidence of complications between two periods: from January to December 2010 (without checklist) and from January 2011 and December 2012 (with checklist), in order to assess the checklist effectiveness. The sample size was 917 patients with an average of 30 months of follow-up. Complications were observed in 107 patients (11.6%) among 917 spinal surgery procedures performed, with 159 (17.3%) complications in total. The overall incidence of complications for trauma, infectious pathology, oncology, and degenerative disease was 22.2%, 19.2%, 18.4%, and 15.3%, respectively. We observed a reduction of the overall incidence of complications following the introduction of the WHO Surgical Checklist: in 2010 without checklist, the incidence of complications was 24.2%, while in 2011 and 2012, following the checklist introduction, the incidence of complications was 16.7% and 11.7%, respectively (mean 14.2%) (p<0.0005). Thus, the SSC appeared to be an effective tool to reduce complications in spinal surgery and we proposed to extend the use of checklist system also to the pre-operative and post-operative phases in order to further reduce the incidence of complications. We also believe that a correct capture and classification of complications is fundamental to generate a clinical decision support system aimed at improving patients’ safety in spinal surgery. In the period between January 2017 and January 2018 we prospectively recorded the adverse events and complications of patients undergoing spinal surgery in our department, without using any collection system. Then we retrospectively recorded the intraoperative and postoperative adverse events of surgically treated patients during the same one-year period, using the SAVES v2 system introduced by Rampersaud and collaborators (Rampersaud YR et al. J Neurosurg Spine 2016 Aug; 25 (2): 256-63) to classify them. In the one-year period from January 2017 to January 2018 a total of 336 patients underwent spinal surgery: 223 for degenerative conditions and 113 for spinal tumors. Comorbidities were collected (Charlson Comorbidity Index [CCI]). Overall, a higher number of adverse events (AEs) was recorded using SAVES compared to the prospective recording without the use of any capture system and the increased number was statistically significant for early postoperative AEs (138/336 vs 44/336, p<0.001). 210 adverse events were retrospectively recorded using the SAVES system (30 intraoperative adverse events, 138 early postoperative and 42 late postoperative adverse events). 99 patients (29.5%) on the cohort had at least one complication. Furthermore, the correlation between some risk factors and the onset of complications or the prolonged length of stay was statistically analyzed. The risk factors taken into account were: age, presence of comorbidities (CCI), ASA score, previous surgery at the same level, type of intervention, location of the disease, duration of the surgery. In particular, the duration of the surgery (more than 3 hours) and the presence of previous surgeries resulted to be risk factors for complications in multivariate analyses

Revision knee arthroplasty is a complex procedure with the number and cost of knee revision procedures performed per year expected to rise. Few studies have examined adverse events following revision arthroplasty. The objective of this study was to determine rates of serious adverse events in patients undergoing revision knee arthroplasty with consideration of the indication for revision (urgent versus elective indications) and to compare these with primary arthroplasty and re-revision arthroplasty. Patients undergoing primary knee arthroplasty were identified in the UK Hospital Episode Statistics. Subsequent revision and re-revision arthroplasty procedures in the same patients and same knee were identified. The primary outcome was 90-day mortality and a logistic regression model was used to investigate factors associated with 90-day mortality and secondary adverse outcomes including infection (undergoing surgery), pulmonary embolism, myocardial infarction, stroke. Urgent indications for revision arthroplasty were defined as infection or fracture, and all other indications were included in the elective indications cohort. 939,021 primary knee arthroplasty cases were included of which 40,854 underwent subsequent revision arthroplasty, and 9,100 underwent re-revision arthroplasty. Revision surgery for elective indications was associated with a 90-day rate of mortality of 0.44% (135/30,826; 95% CI 0.37-0.52) which was comparable to primary knee arthroplasty (0.46%; 4,292/939,021; 95% CI 0.44-0.47). Revision arthroplasty for infection, however, was associated with a much higher mortality of 2.04% (184/9037; 95% CI 1.75-2.35; odds ratio [OR] 3.54; 95% CI 2.81-4.46), as was revision for periprosthetic fracture at 5.25% (52/991; 95% CI 3.94-6.82; OR 6.23; 95% CI 4.39-8.85). Higher rates of pulmonary embolism, myocardial infarction, and stroke were also observed in the infection and fracture cohort. These findings highlight the burden of complications associated with revision knee arthroplasty. They will inform shared decision-making for patients considering revision knee arthroplasty for elective indications. Patients presenting with infection of a knee arthroplasty or a periprosthetic fracture are at very high risk of adverse events. It is important that acute hospital services and tertiary referral centres caring for these patients are appropriately supported to ensure appropriate urgency and an anticipation for increased care requirements

To analyse the efficacy and safety of cellular therapy utilizing Mesenchymal Stromal Cells (MSCs) in the management of rotator cuff(RC) tears from clinical studies available in the literature. We conducted independent and duplicate electronic database searches including PubMed, Embase, Web of Science, and Cochrane Library on August 2021 for studies analyzing the efficacy and safety of cellular therapy (CT) utilizing MSCs in the management of RC tears. VAS for pain, ASES Score, DASH Score, Constant Score, radiological assessment of healing and complications and adverse events were the outcomes analyzed. Analysis was performed in R-platform using OpenMeta [Analyst] software. RESULTS:. 6 studies involving 238 patients were included for analysis. We noted a significant reduction in VAS score for pain at 3 months (WMD=-2.234,p<0.001) and 6 months (WMD=-3.078,p<0.001) with the use of CT. Concerning functional outcomes, utilization of CT produced a significant short-term improvement in the ASES score (WMD=17.090,p<0.001) and significant benefit in functional scores such as Constant score (WMD=0.833,p=0.760) at long-term. Moreover, we also observed a significantly improved radiological tendon healing during the long-term follow-up (OR=3.252,p=0.059). We also noted a significant reduction in the retear rate upon utilization of CT in RC tears both at short- (OR=0.079,p=0.032) and long-term (OR=0.434,p=0.027). We did not observe any significant increase in the adverse events as compared with the control group (OR=0.876,p=0.869). Utilization of CT in RC tear is safe and it significantly reduced pain severity, improved functional outcome, enhanced radiological tendon healing, and mitigated retear rates at short- and long-term follow-up

The multimodal management of canal stenosis is increasing, and inhibitors of central sensitization are playing a crucial role in central sensitization processes. Pregabalin and gabapentin are antiepileptic drugs that reduce presynaptic excitability. The objective of this study was to investigate whether the use of pregabalin and gabapentin is effective in the symptomatic management of canal stenosis. A literature search was conducted in four databases. The inclusion criteria were studies that compared pregabalin or gabapentin with a control group in lumbar canal stenosis. Randomized clinical trials and a comparative retrospective cohort study were included. The main clinical endpoints were VAS/NRS, ODI, and RDQ (Roland Morris Disability Questionnaire) at 2, 4, 8 weeks, and 3 months, adverse events, and walking distance were also collected. Data were combined using Review Manager 5.4 software. Six studies and 392 patients were included. The mean age was 60.25. No significant differences were observed in VAS at 2, 4, and 8 weeks: (MD: 0.23; 95% CI: −0.63-1.09), (MD: −0.04; 95% CI: −0.64 to −0.57), and (MD: −0.6; 95% CI: −1.22 to 0.02). Significant differences were observed in favor of pregabalin with respect to VAS at three months: (MD: −2.97; 95% CI: −3.43 to −2.51). No significant differences were observed in ODI (MD: −3.47; 95% CI: −7.15 to −0.21). Adverse events were significantly higher in the pregabalin/gabapentin group (OR 5.88, 95%CI 1.28-27.05). Walking distance and RDQ could not be compared, although the results were controversial. Gabapentinoids have not been shown to be superior to other drugs used in the treatment of LSS or to placebo. However, they have shown a higher incidence of adverse effects, improved results in VAS at 3 months, and a slight improvement in ambulation at 4 months in combination with NSAIDs compared to NSAIDs in monotherapy

Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts. Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion. Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure. The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease. This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming

Introduction and Objective. Only few studies have investigated the outcome of exercises in patients with glenohumeral osteoarthritis (OA) or rotator cuff tear arthropathy (CTA), and furthermore often excluded patients with a severe degree of OA. Several studies including a Cochrane review have suggested the need for trials comparing shoulder arthroplasty to non-surgical treatments. Before initiation of such a trial, the feasibility of progressive shoulder exercises (PSE) in patients, who are eligible for shoulder arthroplasty should be investigated. The aim was to investigate whether 12 weeks of PSE is feasible in patients with OA or CTA eligible for shoulder arthroplasty. Moreover, to report changes in shoulder function and range of motion (ROM) following the exercise program. Materials and Methods. Eighteen patients (11 women, 14 OA), mean age 70 years (range 57–80), performed 12 weeks of PSE with 1 weekly physiotherapist-supervised and 2 weekly home-based sessions. Feasibility was measured by drop-out rate, adverse events, pain and adherence to PSE. Patients completed Western Ontario Osteoarthritis of the Shoulder (WOOS) score and Disabilities of the Arm, Shoulder and Hand (DASH). Results. Two patients dropped out and no adverse events were observed. Sixteen patients (89%) had high adherence to the physiotherapist-supervised sessions. Acceptable pain levels were reported. WOOS improved mean 23 points (95%CI:13;33), and DASH improved mean 13 points (95%CI:6;19). Conclusions. PSE is feasible, safe and may improve shoulder pain, function and ROM in patients with OA or CTA eligible for shoulder arthroplasty. PSE is a feasible treatment that may be compared with arthroplasty in a RCT setting

Abstract. Objectives. Intra-articular corticosteroid injections (IACIs) are a well-established non-surgical treatment for the symptoms of osteoarthritis (OA), which can provide short-term improvements in pain, disability and quality of life (QoL). Many patients receive recurrent IACIs as temporary relief of their symptoms. Longer-term outcomes for recurrent IACIs remain less well-researched. This meta-analysis aimed to investigate the longer-term risks and benefits of IACIs beyond 3 months. Methods. We searched MEDLINE, EMBASE, and CENTRAL from inception to January 07, 2021, for randomised controlled trials (RCTs) where patients with OA had received recurrent IACIs. Our primary outcomes were pain and function. Secondary outcomes included QoL, disease progression, radiological changes, and adverse events. Mean differences with 95% confidence intervals were reported. Results. Ten RCTs met eligibility criteria (eight for knee OA [n=378], two for trapeziometacarpal OA [n=57]). Patients received 2–5 injections. Follow-up ranged from 6–24 months. Patients with knee OA showed mild improvement in pain at 3, 6, and 9 months but not at 12 months post-injection compared to baseline. Improvements in function were seen from 3–24 months post-injection, decreasing over time. Improvements in QoL continued at 24 months. For patients with trapeziometacarpal OA, mild improvements in pain, function, and QoL were demonstrated at 3–6 months (and 12 months for pain) compared to baseline. No serious adverse events were recorded. No studies reported on time-to-future interventions, or risk of future periprosthetic joint infection. Conclusions. Only mild improvements in pain, function, and QoL were noted after recurrent IACIs up to 6–24 months post-injection. Existing RCTs on recurrent IACI lacks sufficient follow-up data to assess disease progression and time-to-future interventions. These results will inform the RecUrrent Intra-articular Corticosteroid injections in Osteoarthritis (RUbICOn) study which aims to establish the long-term safety outcomes of IACI through data linkage of clinical practice data, hospital episode statistics, and national PROMs

Abstract. Objective. In this phase 2 clinical trial (EudraCT 2011-000541-20) we examined the effect of denosumab versus placebo on osteolytic lesion activity in patients undergoing revision surgery after THA. Methods. Men and women ≥ 30 years old scheduled for revision surgery for symptomatic, radiologically-confirmed osteolysis were randomised (1:1) to receive either denosumab 60mg or placebo subcutaneously eight weeks prior to operation. At surgery, biopsies from the osteolytic membrane-bone interface were taken for histomorphometric analysis of osteoclast number, the primary outcome measure. Secondary outcome measures included other static histomorphometric indices and systemic bone turnover markers. Adverse events and patient-reported clinical outcome scores were recorded as safety endpoints. Results. Of the 24 subjects enrolled, 22 completed the study (10 denosumab) and comprise the per-protocol analysis. There were no differences in baseline characteristics and bone turnover markers between groups (p>0.05). The denosumab group had 78% fewer osteoclasts at osteolytic lesion sites (95% CI −61 to −95, P=0.011), 81% lower osteoclast surface (−70 to −95, P=0.009), and 73% lower eroded surface (−54 to −92, P=0.020) compared to the placebo group. Number of osteoblasts and osteoblast surface were also reduced by 81% (−62 to −100, p=0.021) and 82% (−64 to −101, p=0.017), respectively. Immunocytochemistry for cell proliferation (Ki67) and apoptosis (Caspase 3) identified no differences between the groups (p>0.05). At surgery, serum CTX-I in the denosumab group was 80% lower (−65 to −95, p<0.001), TRAP5b −65% (−40 to −90, p<0.001), PINP −53% (−41 to −65, p<0.001). Patient-reported outcome measures and the rate of adverse events (denosumab 6, placebo 7) were similar between groups (P>0.05). Conclusion. A single dose of denosumab reduced osteoclast activity within osteolytic lesions and was safe to administer. These data provide a biological basis for a phase 3 trial using clinical outcomes of pain, function and prosthesis survival as the study endpoints. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

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

Introduction. Plantar heel pain, or plantar fasciopathy (PF), is a common musculoskeletal complaint, affecting 39% of lower-extremity tendinopathies in general practice. Conservative management is recommended as the first-line treatment, yet many patients continue to experience symptoms even after ten years. There is a significant lack of high-quality evidence for the effectiveness of various treatments, highlighting the need for more research. Minimally invasive surgical options, such as endoscopic plantar fascia release and radiofrequency microtenotomy, have shown promise in reducing pain and improving outcomes. This systematic review aims to evaluate the effectiveness of these minimally invasive surgical treatments compared to non-surgical options in managing PF. Method. The systematic review, registered on PROSPERO (CRD42024490498) and adhering to PRISMA guidelines, searched databases including PubMed, Embase, Cochrane, and others for studies from January 1991 to May 2024. Keywords included plantar fasciitis, plantar fasciopathy, and heel pain. Limited to human trials, the search strategy was refined with an information specialist and found no protocol duplicates. Result. The systematic review identified eight studies involving 495 patients (56.2% women, average age 46.5 years). The studies compared various treatments, including endoscopic plantar fascia release (EPF), mini-scalpel needle (MSN) treatment, ultrasound-guided pulsed radiofrequency (UG-PRF), and needle electrolysis (NE), to non-surgical interventions and corticosteroid injections (CSI). Primary outcomes focused on pain reduction, with some needle treatments showing superior results (between-group diffence). No severe adverse events were reported. Conclusion. In conclusion, plantar fasciopathy (PF) remains a prevalent and challenging condition, that can be resistant to conservative treatments. This systematic review highlights the potential of minimally invasive surgical options, such as endoscopic plantar fascia release and needle treatments, in reducing pain and improving functional outcomes. Despite some needle treatments showing superior results, the overall lack of high-quality evidence underscores the need for further research to establish the most effective management strategies for PF

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

Introduction. Polyacrylamide hydrogel (iPAAG. 1. ), is CE marked for treating symptomatic knee osteoarthritis (OA), meeting the need for an effective, long-lasting, and safe non-surgical option. This study evaluates the efficacy and safety of a single 6 ml intra-articular injection of iPAAG in participants with moderate to severe knee OA over a 5-year post-treatment period, presenting data from the 4-year follow up. Method. This prospective multicentre study (3 sites in Denmark) involved 49 participants (31 females) with an average age of 70 (range 44 – 86 years). They received a single 6 mL iPAAG injection. All participants provided informed consent and re-consented to continue after 1 year. The study followed GCP principles and was approved by Danish health authorities and local Health Research Ethics committees. Twenty-seven participants completed the 4-year follow-up. The study evaluated WOMAC pain, stiffness, function, and Patient Global Assessment (PGA) of disease impact. Changes from baseline were analysed using a mixed model for repeated measurement (MMRM). Sensitivity analyses were applied on the extension data, where the MMRM analysis was repeated only including patients in the extension phase and an ANCOVA model was used, replacing missing values at 4-years with baseline values (BOCF). Results. The planned MMRM analysis (n=49) revealed a statistically significant decrease in WOMAC pain subscale scores (-22.0; 95%CI: -29.5; -14.4) from baseline to 4-years. Analysis of the extension phase (n=27) showed similar results (-21.8; 95%CI: -29.0; -14.6) compared to the initial analysis. Furthermore, BOCF analysis indicated a statistically significant reduction in WOMAC pain subscale scores from baseline (-13.0 units). Four new adverse events were reported between the 3-year and 4-year visits; none were related to treatment. Conclusions. This study shows that single injections of 6 ml intra-articular iPAAG were well tolerated and continued to provide clinically important effectiveness at 4-years after treatment. Acknowledgements. The study was sponsored by Contura International A/S

Intraoperative cell salvage involves the collection of blood directly from the operative field. The purpose of this study was to determine if its use reduces the need for postoperative allogenic blood transfusion, assess any adverse events and its effect on duration of postoperative stay in primary hip arthroplasty. We prospectively examined the effect of intraoperative cell salvage on the need for postoperative allogenic blood transfusion. Between February 2009 and August 2010, a total of 77 patients who underwent primary total hip arthroplasty were included in the study, under the care of the senior author (KB). All patients had a diagnosis of osteoarthritis. Intraoperative cell salvage was used in 38 patients and not used in 39 patients. We prospectively collected data on patient demographics, ASA grade, preoperative and postoperative haematological features, number of units of packed red cells transfused and the volume of intraoperative reinfused cell salvaged blood was. Total inpatient stay and any postoperative adverse events were recorded. No patients in the cell salvage group required postoperative allogenic blood transfusion compared to three patients (7.7%) in the conventional group. Postoperative decrease in haemoglobin was less in the cell salvage group (2.57 vs. 3.3 g/dL). The mean length of postoperative inpatient stay was shorter in the cell salvage group (5.1 vs. 6.41 days). Three patients in the cell salvage group had adverse events (1 UTI, 1 hyponatraemia, 1 colonic pseudo-obstruction). Three patients in the conventional group experienced adverse events (2 superficial wound infections, 1 DVT). An average of 361mls of cell salvaged blood was reinfused (110–900mls). We have found that the use of intraoperative cell salvage in patients undergoing primary total hip arthroplasty reduces the need for post operative allogenic blood transfusion with no increase in adverse events when compared to conventional measures of blood preserving techniques

‘Safety’ is at the centre of surgical practice with the aim of minimising the risks of complications and adverse events. Much evidence, based on either retrospective case series or prospective cohorts, concerns the frequency of adverse events. There may be a temptation to describe a procedure as ‘safe’ if no – or few – serious adverse events (the numerator) have occurred out of a number of procedures performed (the denominator). In 1983, Hanley and Lippman-Hand described a simple algorithm to calculate the 95% upper Confidence Interval for data sets in which the numerator is zero (ie series in which there no adverse events). Paediatric orthopaedics suffers from small datasets which may make its researchers especially prone to the erroneous attribution of procedures being ‘safe’. The aim of the current study was to formally assess the evidence on which paediatric orthopaedic surgical procedures are described as ‘safe’. In particular, the objective was to ascertain the proportion of studies describing a procedure as ‘safe’ which achieved a 95% upper limit Confidence Interval of risk of 5% for major adverse events. We examined all papers published by the Journal of Paediatric Orthopaedics in the previous 5 years searching for the single term ‘safe’. 84 papers were returned and 71 were considered appropriate for analysis. Of these 60 papers positively identified their intervention as ‘safe’. These papers were read in full and the number of interventions was recorded along with the rate of complication. 66 data sets were created and the 95% upper confidence interval was calculated for complication rates. Only 16 out of 66 data sets could safely predict a major complication rate of under 5%. Our work would tend to suggest that a failure to apply proper statistical tools is leading to procedures being erroneously classified as safe in the published literature

Summary. In this study, OsteoAMP® bone graft showed superior fusion rates as compared to rhBMP-2 at all timepoints (p<0.004). Additionally, OsteoAMP® bone graft had >80% few adverse events as compared to rhBMP-2. Introduction. Adverse events and complications related to use of rhBMP-2 have raised many ethical, legal, and reimbursement concerns for surgeons. OsteoAMP® bone graft is an allograft derived growth factor, rich in osteoinductive, angiogenic, and mitogenic proteins. The following data displays a blinded, multi -center study evaluating and comparing fusion outcomes between rhBMP-2 and OsteoAMP® bone graft. Patients & Methods. A total of 254 consecutive patients (383 total levels) were treated with TLIF or LLIF spine fusion procedures. A group of 70 patients (53.3 ± 11.1 y/o) were treated with rhBMP-2 (Infuse®/Inductos®, Medtronic) and local bone inside of a PEEK interbody cage with an average of 1.44 levels per surgery. A group of 184 patients (60.5 ± 13.1 y/o) were treated with OsteoAMP® (Advanced Biologics) and local bone inside of a PEEK interbody cage with an average of 1.53 levels per surgery. Fusion assessments were made by a blinded independent radiologist based on radiograph and CT images at 6w, 3m, 6m, 12m, and 18m follow up. Radiographically evident adverse events were also assessed in a blinded manner by an independent radiologist. Results. Overall fusion analysis showed superiority in efficacy of OsteoAMP® over rhBMP-2 at all time points (p<0.004). Use of rhBMP-2 produced limited early fusions at 6 months (22.7%) yet improved at 1 year (71.4%). OsteoAMP® facilitated fusion for the majority of patients by 6 months (54.1%) and nearly all patients within 1 year (93.9%). At 18 months, 99.3% of OsteoAMP® patients had fused while the rhBMP-2 arm had an 86.7% fusion rate. Total time for fusion for OsteoAMP® was approximately half that of rhBMP-2 at 211.4 days and 407.1 days respectively. A subset cohort of 47 patients in the rhBMP-2 arm had OsteoAMP® packed anterior to the PEEK cage. When OsteoAMP® was used as an extender to rhBMP-2 in this manner, fusion rates increased at all timepoints (p=0.05 at 18 months) over patients that only had rhBMP-2 and local bone within the disc space. Though, the fusion rates of OsteoAMP® without rhBMP-2 remained higher than the rhBMP-2/local bone/OsteoAMP® extender cohort at all timepoints (p<0.05). To further isolate the effect of OsteoAMP, a subset cohort of 52 patients within the OsteoAMP® treatment arm in the absence of rhBMP-2 did not utilise bone marrow aspirate. The fusion rates of patients within this cohort was statistically higher at 6 months but did not show statistically higher fusion rates at 3 months, 12 months, or 18 months (p>0.12). When compared to the rhBMP-2 study arm, patients within the OsteoAMP® arm that did not receive bone marrow aspirate demonstrated higher fusion rates at all time points (p<0.04 at 12 and 18 months). The rhBMP-2 arm had more than 5 times the incidence of radiologically evident adverse events (osteolysis and ectopic bone formation) compared to the OsteoAMP® arm (43.3% vs. 8.2%, respectively). Discussion. Despite its use with an older patient population and a higher number of levels per surgery, OsteoAMP® has shown great promise as a faster and safer alternative to rhBMP-2 in lumbar spine surgery

Introduction and Objective. Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appear to improve several outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary objective of this trial is to determine the effectiveness of THA followed by standard care compared to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT, on changes in hip pain and function, in patients with severe hip OA after 6 months. Materials and Methods. This is a protocol for a multicentre, parallel-group, assessor blinded, randomised controlled superiority trial. Patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA or PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40-meter fast-paced walk test, 30-second chair stand test, and number of serious adverse events. Results. The trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158) in February 2019 and registration was performed at . ClinicalTrials.gov. (NCT04070027) in August 2019. Recruitment was initiated on the 2. nd. of September 2019 and the final deadline will be on the 30. th. of June 2021, or when a sample size of 120 patients has been accomplished. Conclusions. The results of the current trial are expected to enable evidence-based recommendations, which may be used to facilitate the shared-decision making process in the discussion of treatment strategy for the individual patient with severe hip OA. All results will be presented in peer-reviewed scientific journals and international conferences

Introduction and Objective. Tranexamic acid (TXA) is used across surgical specialties to reduce perioperative bleeding. It has been shown to be effective in trauma, spinal surgery, and lower limb arthroplasty. The aim of this study is to investigate the clinical effectiveness of TXA in all types of shoulder surgery on bleeding and non-bleeding related outcomes. Materials and Methods. This study was registered prospectively on the PROSPERO database (ref: CRD42020185482). A systematic review and meta-analysis of randomised controlled trials (RCTs) investigating intra-operative use of TXA versus placebo in any type of surgery to the shoulder girdle. Electronic databases searched included MEDLINE, EMBASE, PsychINFO, and the Cochrane Library. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and Jadad score. Certainty of findings were reported using the GRADE approach. The primary outcome was total blood loss. Secondary outcomes included patient reported outcome measures, adverse events, and rate of blood transfusion. Results. Eight RCTs were included in the systematic review and data from 7 of these studies pooled in the meta-analysis. A total of 708 patients were randomized across the studies (406 received TXA, 302 received placebo). Studies included patients undergoing anatomic or reverse total shoulder arthroplasty, open Latarjet surgery, and arthroscopic rotator cuff repair. Pooled analysis demonstrated significant reduction in perioperative bleeding with TXA compared to controls; estimated total blood loss (mean difference [MD], −209.66; 95% CI −389.11 to −30.21; p=0.02), and post-operative blood loss (via drain output) (MD, −84.8ml; 95% CI, −140.04 to −29.56; p=0.003). A mean difference in Visual Analogue Scale (VAS) of 2.93 was noted in favour of TXA (95% CI 0.2 to 5.66; p=0.04). Conclusions. Whilst noting some risk of bias within the studies, TXA was effective in reducing blood loss and pain in shoulder surgery. There may be a benefit of TXA use in both open and arthroscopic shoulder procedures. Larger, low risk of bias, RCTs for specific surgical shoulder procedures are required

Xiapex is a novel non-surgical intervention for the treatment of Dupuytren's contracture. It comprises a fixed-ratio mixture of two purified collagenolytic enzymes (AUX-I [clostridial type I collegenase] and AUX II [clostridial type II collagenase]) isolated from the medium of Clostridium histolyticum. Xiapex targets the contracture through the injection of enzymes into the pathologic diseased cords. The objectives of this study were to evaluate the safety and efficacy of Xiapex in patients with Dupuytren's Contracture, the recovery and associated use of health care resources. The study commenced in June 2011 and was completed in 11 months. 15 patients were screened for the study, 12 patients were eligible (10 male:2 female). All 12 patients completed the trial and 2 patients received multiple injections, one had two fingers affected and the other had two joints affected in one finger. Following screening visit to determine patient suitability, the patient received their first injection usually within 7 days. Xiapex was injected directly into the palpable cord. 24 hours after injection patients were reviewed and a “finger extension procedure” was performed if the cord had not spontaneously ruptured. Patients were then followed up at 7 days, 30 days and 6 months. Assessments at each visits included: Finger Goniometry, Physician and Subject Global Assessment and Satisfaction, Health Care Resource Utilization and URAM (function assessment) and adverse events. Of the 14 cords injected all ruptured after finger extension. No patient experienced any serious adverse events, but a number of more minor adverse events were recorded including skin tears, pain at injection site, swelling and bruising. At the time of final follow-up recurrence rates were 14%. In conclusion, Xiapex is suitable for appropriately selected patients who are affected by Dupuytren's contractures and who have a well-developed palpable cord

Introduction and Objective. Knee osteoarthritis (KOA) is a frequent disease for which therapeutic possibilities are limited. In current recommendations, the first-line analgesic is acetaminophen. However, low efficacy of acetaminophen, frequently leads to the use of weak opioids (WO) despite their poor tolerance, especially in elderly patients. The primary objective was to compare the analgesic efficacy and safety of a new wearable transcutaneous electrical nerve stimulation (W-TENS) to weak opioids (WO) in the treatment of moderate to severe, nociceptive, chronic pain in knee osteoarthritis patients. Materials and Methods. ArthroTENS study is a phase 3, non-inferiority, multicentric, prospective, randomized, single-blinded for primary efficacy outcome, controlled, in 2-parallel groups, clinical study comparing W-TENS versus WO over a 3-month controlled period with an additional, optional, non-controlled, 3-month follow-up for patients in W-TENS group. The co-primary outcome was KOA pain intensity (PI) at month 3 and the number of adverse events (AEs) over 3 months. Results. The non-inferiority of W-TENS was demonstrated in both the PP and ITT populations. At M3, PI in PP population was 3.87 (2.12) compared to 4.66 (2.37) (delta: −0.79 (0.44); 95% CI (−1.65; 0.08)) in W-TENS and WO groups, respectively. Since the absolute value of the 95% CI of the between-treatments mean PI difference [−1.71, – 0.12] was above 0 in ITT set, the planned superiority analysis was performed, demonstrating that W-TENS was significantly superior to WO at M3 (P=0.0124). At M1 and M3, the W-TENS group reached the absolute minimal clinically important difference (MCID) for an analgesic (1.8 (2.1) and 2.1 (2.3), respectively), corresponding to a 20 mm reduction in PI (interquartile range: 15–30) on a 0–100 mm visual analogic scale – i.e. 2 points on a numerical rating scale – which equates to “much better”. Conversely, in the WO group, a 0.5 (1.8) and a 1.1 (2.1) reduction in PI were observed at M1 and M3, respectively, while a 1-point reduction in PI is required to be considered as a “slightly better” improvement. In WO group, AEs were the common systemic AEs reported with WO (nausea, constipation, drowsiness, dizziness, pruritus, vomiting, dry mouth). AEs in W-TENS group were local, such as local cutaneous reaction (erythema). Thirty-nine (70.9%) patients wished to extend W-TENS treatment for 3 additional months. Only one patient discontinued this additional period and results were maintained at M6. Conclusions. W-TENS was more effective and better tolerated than WO in the treatment of nociceptive KOA chronic pain and could represent an interesting non-pharmacological alternative to WO

Background and Purpose. Most information regarding adverse events (AEs) following osteopathic treatment is anecdotal; empirical data are limited. We explored the feasibility of online questionnaires to capture AEs prospectively within an osteopathic teaching clinic, and explored associations between a priori selected variables and reporting AEs. Methods and Results. We piloted a prospective patient-completed online questionnaire rating (‘none’/‘mild’/‘moderate’/‘severe’/‘don't know’) 14 symptoms (e.g. ‘pain’, ‘headaches’, ‘dizziness’, ‘nausea’, ‘tingling’) at five time-points within one week post-treatment. We recruited patients presenting with a new complaint. Additional data on concomitant symptoms, demographics, and treatment approach were obtained. Using logistic regression we explored associations between reporting an event at 24 hours and age, gender, high-velocity-low-amplitude-thrust and smoking status. ‘Pain’ (82%), ‘stiffness’ (40%) and ‘lack of mobility’ (28%) were the main presenting complaints, and ‘lower back’ (39%), ‘head/neck’ (26%) and ‘upper limb’ (14%) the commonest regions affected. AEs were reported by 83% of patients; ‘pain’ (74%), ‘stiffness’ (58%) and ‘unexpected tiredness’ (10%) were the most frequently reported. These peaked at 24, 48 and 24 hours respectively and were commonly rated as ‘mild’. There was no evidence for age, gender, HVLAT in crude or adjusted models; there were very weak/weak suggestions smoking cessation may be associated with reporting AEs; adjusted OR for ex-smokers versus never-smokers was 3.50 (0.66–18.40; P=0.14); ex-smokers versus smokers was 5.67 (0.85–37.80; P=0.07)). Conclusion. Using online questionnaire is feasible within a teaching clinic. Over 80% of patients reported one or more mild adverse events post-treatment. A larger study may be warranted testing the hypothesis smoking status predicts reporting of adverse events. No conflicts of interest. Sources of funding: The European School of Osteopathy. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting