Aims

The present study aimed to investigate whether patients with inflammatory bowel disease (IBD) undergoing joint arthroplasty have a higher incidence of adverse outcomes than those without IBD.

The Spine Adverse Events Severity System (SAVES) and Orthopaedic Surgical Adverse Events Severity System (OrthoSAVES) are standardised assessment tools designed to record adverse events (AEs) in orthopaedic patients. The primary objective was to compare AEs recorded prospectively by orthopaedic surgeons compared to trained independent clinical reviewers. The secondary objective was to compare AEs following spine, hip, knee, and shoulder orthopaedic procedures. Over a 10-week period, three orthopaedic spine surgeons recorded AEs following all elective procedures to the point of patient discharge. Three orthopaedic surgeons (hip, knee, and shoulder) also recorded AEs for their elective procedures. Two independent reviewers used SAVES and OrthoSAVES to record AEs after reviewing clinical notes by surgeons and other healthcare professionals (e.g. nurses, physiotherapists). At discharge, AEs recorded by the surgeons and independent reviewers were recorded in a database. AE data for 164 patients were collected (48 spine, 52 hip, 33 knee, and 31 shoulder). Overall, 98 AEs were captured by the independent reviewers, compared to 14 captured by the surgeons. Independent reviewers recorded significantly more AEs than surgeons overall, as well as for each individual group (i.e. spine, hip, knee, shoulder) (p2), but surgeons failed to record minor events that were captured by the independent reviewers (e.g. urinary retention and cutaneous injuries; AEs Grade 0.05). AEs were reported in 21 (43.8%), 19 (36.5%), 12 (36.4%), and five (16.1%) spine, hip, knee, and shoulder patients, respectively. Nearly all reported AEs required only simple or minor treatment (e.g. antibiotic, foley catheter) and had no effect on outcome. Two patients experienced AEs that required invasive or complex treatment (e.g. surgery, monitored bed) that had a temporary effect on outcome. Similar complication rates were reported in spine, hip, knee, and shoulder patients. Independent reviewers reported more AEs compared to surgeons. These findings suggest that independent reviewers are more effective at capturing AEs following orthopaedic surgery, and thus, could be recruited in order to capture more AEs, enhance patient safety and care, and maximise different complication diagnoses in alignment with proposed diagnosis-based funding models

Adverse events (AEs) following spine surgery are very common. It is important to monitor the incidence of AEs to ensure that appropriate practices are implemented to minimise AEs and improve patient outcomes. The Spine Adverse Events Severity System (SAVES) is a validated AE recording tool specifically designed for spine surgery and the Orthopaedic Surgical Adverse Events Severity System (OrthoSAVES) is a similar tool intended for general orthopaedic surgery. The main objective was to prospectively collect AE data from spine surgery patients using SAVES and OrthoSAVES and compare their viability and applicability for use. The longterm objective is to enhance patient safety by tracking AEs with a view towards potentially changing future healthcare practices to eliminate the risk factors for AEs. For a 10-week period in June-September 2015, three spine surgeons used SAVES to record AEs experienced by any elective spine surgery patients. In addition, a trained independent clinical reviewer with access to electronic records, medical charts, and allied health professionals (e.g. nurses, physioterhapists) used SAVES and OrthoSAVES to record AEs for the same patients. At discharge, the SAVES forms from the surgeons and SAVES and OrthoSAVES forms from the independent reviewer were collected and all AEs were recorded in a database. In 48 patients, the independent reviewer recorded a total of 45 AEs (4 intra-operative, 41 post-operative), compared to the surgeons who recorded a total of 8 AEs (2 intra-operative, 6 post-operative) (P2) were recorded by both the independent reviewer and surgeons. OrthoSAVES had the capacity to directly record 3 additional AEs that had to be included in the “Other” section on SAVES. SAVES and OrthoSAVES are valuable tools for recording AEs. Use of SAVES and OrthoSAVES has the potential to enhance patient care and safety by ensuring AEs are followed by the surgeon during their in-hospital stay and prior to discharge. Independent reviewers are more effective at capturing AEs following spine surgery, and thus, could be recruited in order to capture more AEs and maximise different complication diagnoses in alignment with proposed diagnosis-based funding models. The next step is to analyse AE data identified by the hospital discharge abstract to determine whether retrospective administrative coding can adequately record AEs compared to prospectively-collected AE data with SAVES/OrthoSAVES

Aims. This study aimed to investigate the risk of postoperative complications in COVID-19-positive patients undergoing common orthopaedic procedures. Methods. Using the National Surgical Quality Improvement Programme (NSQIP) database, patients who underwent common orthopaedic surgery procedures from 1 January to 31 December 2021 were extracted. Patient preoperative COVID-19 status, demographics, comorbidities, type of surgery, and postoperative complications were analyzed. Propensity score matching was conducted between COVID-19-positive and -negative patients. Multivariable regression was then performed to identify both patient and provider risk factors independently associated with the occurrence of 30-day postoperative adverse events. Results. Of 194,121 included patients, 740 (0.38%) were identified to be COVID-19-positive. Comparison of comorbidities demonstrated that COVID-19-positive patients had higher rates of diabetes, heart failure, and pulmonary disease. After propensity matching and controlling for all preoperative variables, multivariable analysis found that COVID-19-positive patients were at increased risk of several postoperative complications, including: any adverse event, major adverse event, minor adverse event, death, venous thromboembolism, and pneumonia. COVID-19-positive patients undergoing hip/knee arthroplasty and trauma surgery were at increased risk of 30-day adverse events. Conclusion. COVID-19-positive patients undergoing orthopaedic surgery had increased odds of many 30-day postoperative complications, with hip/knee arthroplasty and trauma surgery being the most high-risk procedures. These data reinforce prior literature demonstrating increased risk of venous thromboembolic events in the acute postoperative period. Clinicians caring for patients undergoing orthopaedic procedures should be mindful of these increased risks, and attempt to improve patient care during the ongoing global pandemic. Cite this article: Bone Jt Open 2023;4(9):704–712

Aims

The aims of this study were to determine the rates of surgical complications, reoperations, and readmissions following herniated lumbar disc surgery, and to investigate the impact of sociodemographic factors and comorbidity on the rate of such unfavourable events.

The “Universal Protocol” (UP) was launched as a regulatory compliance standard by the Joint Commission on 1st July 1 2004, with the primary intent of reducing the occurrence of wrong-site and wrong-patient surgery. As we’re heading into the tenth year of the UP implementation in the United States, it is time for critical assessment of the protocol’s impact on patient safety related to the incidence of preventable never-events. This article opens the debate on the potential shortcomings and pitfalls of the UP, and provides recommendations on how to circumvent specific inherent vulnerabilities of this widely established patient safety protocol.

In the Unites States, approximately 24% of people undergoing primary total knee or total hip arthroplasty (TKA, THA) are chronic opioid users pre-operatively. Few studies have examined the incidence of opioid use prior to TKA/THA and whether it predicts outcomes post-surgery in the Australian context. The aim was to determine: (i) the proportion of TKA and THA patients who use opioids regularly (daily) pre-surgery; (ii) if opioid use pre-surgery predicts (a) complication and readmission rates to 6-months post-surgery, (b) patient-reported outcomes to 6-months post-surgery. A retrospective cohort study was undertaken utilising linked individual patient-level data from two independent databases comprising approximately 3500 people. Patients had surgery between January 2013 and June 2018, inclusive at Fairfield and Bowral Hospitals. Following data linkage, analysis was completed on 1185 study participants (64% female, 69% TKA, mean age 67 (9.9)). 30% were using regular opioids pre-operatively. Unadjusted analyses resulted in the following rates in those who . were. vs . were not. using opioids pre-operatively (respectively); acute adverse events (39.1% vs 38.6%), acute significant adverse events (5.3% vs 5.7%), late adverse events: (6.9% vs 6.6%), total significant adverse events: (12.5% vs 12.4%), discharge to inpatient rehab (86.4% vs 88.6%), length of hospital stay (5.9 (3.0) vs 5.6 (3.0) days), 6-month post-op Oxford Score (38.8 (8.9) vs 39.5 (7.9)), 6 months post-op EQ-VAS (71.7 (20.2) vs 76.7 (18.2), p<0.001), success post-op described as “much better” (80.2% vs 81.3%). Adjusted regression analyses controlling for multiple co-variates indicated no significant association between pre-op opioid use and adverse events/patient-reported outcomes. Pre-operative opioid use was high amongst this Australian arthroplasty cohort and was not associated with increased risk of adverse events post-operatively. Further research is needed in assessing the relationship between the amount of pre-op opioid use and the risk of post-operative adverse events

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

Introduction. Circular frames for ankle fusion are usually reserved for complex clinical scenarios. Current literature is heterogenous and difficult to interpret. We aimed to study the indications and outcomes of this procedure in detail. Materials & Methods. A retrospective cohort study was performed based on a prospective database of frame surgeries performed in a tertiary institution. Inclusion criteria were patients undergoing complex ankle fusion with circular frames between 2005 and 2020, with a minimum 12-month follow up. Data were collected on patient demographics, surgical indications, comorbidities, surgical procedures, external fixator time (EFT), length of stay (LOS), radiological and clinical outcomes, and adverse events. Factors influencing radiological and clinical outcomes were analysed. Results. 47 patients were included, with a mean follow-up of three years. The mean age at time of surgery was 63.6 years. Patients had a median of two previous surgeries. The median LOS was 8.5 days, and median EFT was 237 days. Where simultaneous limb lengthening was performed, the average lengthening was 2.9cm, increasing the EFT by an average of 4 months. Primary and final union rates were 91.5% and 95.7% respectively. At last follow-up, ASAMI bone scores were excellent or good in 87.2%. ASAMI functional scores were good in 79.1%. Patient satisfaction was 83.7%. 97.7% of patients experienced adverse events, most commonly pin-site related, with major complications in 30.2% and re-operations in 60.5%. There were 3 amputations. Adverse events were associated with increased age, poor soft tissue condition, severe deformities, subtalar fusions, peripheral neuropathy, peripheral vascular disease, and prolonged EFT. Conclusions. Complex ankle fusion using circular frames can achieve good outcomes in complicated clinical scenarios, however patients can expect a prolonged time in the frame and high rates of adverse events. Multiple risk factors were identified for poorer outcomes, which should be considered in patient counselling and prognostication

Aims. This study investigated the effects of transcatheter arterial embolization (TAE) on pain, function, and quality of life in people with early-stage symptomatic knee osteoarthritis (OA) compared to a sham procedure. Methods. A total of 59 participants with symptomatic Kellgren-Lawrence grade 2 knee OA were randomly allocated to TAE or a sham procedure. The intervention group underwent TAE of one or more genicular arteries. The control group received a blinded sham procedure. The primary outcome was knee pain at 12 months according to the Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale. Secondary outcomes included self-reported function and quality of life (KOOS, EuroQol five-dimension five-level questionnaire (EQ-5D-5L)), self-reported Global Change, six-minute walk test, 30-second chair stand test, and adverse events. Subgroup analyses compared participants who received complete embolization of all genicular arteries (as distinct from embolization of some arteries) (n = 17) with the control group (n = 29) for KOOS and Global Change scores at 12 months. Continuous variables were analyzed with quantile regression, adjusting for baseline scores. Dichotomized variables were analyzed with chi-squared tests. Results. Overall, 58 participants provided questionnaire data at 12 months. No significant differences were found for the primary and secondary outcomes, with both groups improving following the procedure. At 12 months, KOOS pain scores improved by 41.3% and 29.4% in the intervention and control groups, respectively. No adverse events occurred. Subgroup analysis indicated that the complete embolization group had significantly better KOOS Sports and Recreation, KOOS Quality of Life, and Global Change scores than the control group; 76.5% of participants who received complete embolization reporting being moderately or much better compared to 37.9% of the control group. Conclusion. TAE might produce benefits above placebo, but only when complete embolization of all genicular arteries is performed. Further comparative studies are required before definitive conclusions regarding the effectiveness of TAE can be made. Level of evidence: I. Cite this article: Bone Jt Open 2023;4(3):158–167

The purpose of our study is to examine the outcome of patients undergoing outpatient total hip arthroplasty with a BMI >35. Case-control matching on age, gender (46% female;54%male), and ASA (mean 2.8) with 51 outpatients BMI≥35 kg/m. 2. (mean of 40 (35–55)), mean age of 61 (38–78) matched to 51 outpatients BMI<35 kg/m. 2. (mean of 27 (17–34)) mean age 61 (33–78). Subsequently 47 inpatients BMI≥35 kg/m. 2. (mean of 40 (35–55)) mean age 62 (34–77) were matched outpatients BMI≥35 kg/m. 2. For each cohort, adverse events, readmission in 90 days, reoperations were recorded. Rate of adverse events was significantly higher in BMI ≥35: 15.69% verus 1.96% (p=0.039) with 5 reoperations in the BMI≥35 cohort vs 0 in the BMI<35 kg/m. 2. (p= 0.063). Readmissions did not differ between groups (p=0.125). No significant difference for all studied outcomes between the outpatient and inpatients cohorts with BMI≥35 kg/m. 2. The most complications requiring surgery/medical intervention (3B) were in the inpatient cohort of patients >35. The prevalence of Diabetes and Obstructive Sleep apnea was 21.6% and 29.4% for BMI>35 compared to 9.8% and 11.8%, for BMI <35, respectively. Severely obese patients have an overall higher rate of adverse events and reoperations however it should not be used a sole variable for deciding if the patient should be admitted or not

Introduction. Osseointegration has been established as a promising approach for the reconstruction of amputated limbs, particularly for amputees suffering from traditional socket prosthesis (TSP). While Osseointegration was originally developed with a screw fixation design, several Osseointegration devices adopting a modern press-fit design have also been introduced. In this study, medium-term outcomes for patients with the two most common press-fit osseointegration implant used worldwide are analysed. Materials and Methods. This is a cross-sectional analysis containing a cohort of Osseointegration patients treated in several centres worldwide. We analyzed a total of 93 patients with an average follow-up time of 6.52 years. Functional, Mobility and patient reported outcomes were collected pre-operatively and during follow-up. All postoperative adverse events (infection, revision surgery, fractures, and implant failures) were also analyzed. Results. Crude analysis of the data indicated that all 93 patients continue to use their osseointegrated prosthesis. Significant improvements for all outcome measures were observed. However, several adverse events including 19 implant revisions, 8 periprosthetic fractures and 43 surgical debridements were also reported. A detailed analysis was performed on each adverse event type to evaluate possible causes. Conclusions. At 5 years post-surgery, Osseointegration continues to provide amputees with improvements on function and quality of life which were previously unattainable with socket prosthesis. However, the benefits are accompanied with a relatively high risk of adverse events. Further research in standardizing clinical practice and the development of better implant may offer a reduction to these risks

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

Aim. Tedizolid is an oxazolidinone antibiotic that: (i) is recommended at the dose of 200 once daily in patients with skin and soft tissue infection; (ii) seems to have a better long-term hematological and neurological safety profile in comparison with linezolid; (iii) remains active on multidrug-resistant (MDR) Gram-positive pathogens. Consequently, it might represent an option as suppressive antimicrobial treatment (SAT) in patients with complex implant-associated bone and joint infection (BJI) due to MDR Gram-positive pathogens. Method. We performed a cohort study (2017–2020) to evaluate the long-term safety of tedizolid (200mg qd) as SAT in patients with implant-associated BJI. In all cases, the use of tedizolid was validated as the last oral treatment option during multidisciplinar meetings in a reference center for the management of BJI. Serious adverse events, any reason for discontinuation, and standard biological data, were prospectively collected. Results. Seventeen patients (13 males; median age 73 years) received tedizolid as SAT for late complex prosthetic-joint infections (n=16) or osteosynthesis (n=1). Pathogens were MDR coagulase negative staphylococci (16 patients), Corynebacterium striatrum (2 patients), Enterococcus faecium (1 patient) and/or S. aureus (1 patient). Tedizolid was always started after a primary treatment (median duration of intravenous 47 days; followed by linezolid in 12 patients including 9 who experienced linezolid-induced serious adverse event) that followed a surgery, mainly debridement and implant retention (13 patients). Median duration of tedizolid was 6 months (min, 1 month; max, 31 months). The only reason for discontinuation was a failure of the conservative strategy that occurred in four patients (17%) during the follow-up. No patients developed a serious adverse event, or a discontinuation of tedizolid due to an adverse event. Anemia was observed in two patients, who had already other known cause of anemia (chronic leukemia and oesophageal varices); stable thrombopenia was observed in a cirrhotic patient (80 G/L, stable during the treatment course of 12 months); and a transient mild neutropenia (1.4 G/L) was observed in another patient (Figure). No neurological adverse event was observed. Conclusions. Tedizolid seems to be a safe option as SAT in patients with complex implantassociated BJI due MDR Gram-positive pathogens. For any tables or figures, please contact the authors directly

Aims. The primary objective of this study was to compare the postoperative infection rate between negative pressure wound therapy (NPWT) and conventional dressings for closed incisions following soft-tissue sarcoma (STS) surgery. Secondary objectives were to compare rates of adverse wound events and functional scores. Methods. In this prospective, single-centre, randomized controlled trial (RCT), patients were randomized to either NPWT or conventional sterile occlusive dressings. A total of 17 patients, with a mean age of 54 years (21 to 81), were successfully recruited and none were lost to follow-up. Wound reviews were undertaken to identify any surgical site infection (SSI) or adverse wound events within 30 days. The Toronto Extremity Salvage Score (TESS) and Musculoskeletal Tumor Society (MSTS) score were recorded as patient-reported outcome measures (PROMs). Results. There were two out of seven patients in the control group (28.6%), and two out of ten patients in the intervention group (20%) who were diagnosed with a SSI (p > 0.999), while one additional adverse wound event was identified in the control group (p = 0.593). No significant differences in PROMs were identified between the groups at either 30 days (TESS, p = 0.987; MSTS, p = 0.951) or six-month (TESS, p = 0.400) follow-up. However, neoadjuvant radiotherapy was significantly associated with a SSI within 30 days of surgery, across all patients (p = 0.029). The mean preoperative modified Glasgow Prognostic Score (mGPS) was also significantly higher among patients who developed a postoperative adverse wound event (p = 0.028), including a SSI (p = 0.008), across both groups. Conclusion. This is the first RCT comparing NPWT with conventional dressings following musculoskeletal tumour surgery. Postoperative wound complications are common in this group of patients and we observed an overall SSI rate of 23.5%. We propose proceeding to a multicentre trial, which will help more clearly define the role of closed incision NPWT in STS surgery. Cite this article: Bone Jt Open 2021;2(12):1049–1056

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

Introduction. This study reports on minimum 2 year follow up outcomes on functional and quality of life of patients after undergoing bilateral osseointegration in comparison to traditional socket prosthesis. Materials & Methods. This is a prospective pilot study of 35 patients, consisting of 30 males and 5 females, aged 22–66 (mean 36) years at surgery, with minimum two-year follow-up. Selection criteria were age over 18 years, bilateral amputees who had socket-related problems or were wheelchair-bound with short stumps and non-reconstructable limb pathology. Principle outcome measures included the Questionnaire for persons with a Trans-Femoral Amputation (Q-TFA), Short Form Health Survey 36 (SF-36), Six Minute Walk Test (6MWT), Timed Up and Go (TUG), and K-levels. Adverse events were recorded including infection, revision surgery, fractures, and implant failures. Results. Comparisons were made using differences between the mean pre-operative and mean post-operative values for each outcome measure. Significant improvements in all validated outcome measures were observed. All patient who were wheelchair bound prior to the surgery were able to mobilise post operatively. The occurrence levels of adverse events, including the infection rate and revision rate within this patient cohort, were similar to other established trans-femoral osseointegration studies. Conclusions. These preliminary results indicate that osseointegration surgery is a safe and effective alternative treatment for bilateral amputees experiencing socket-related discomfort. Compared to the suboptimal outcomes of socket prostheses, osseointegration currently provides one of the best chances for any bilateral amputee to walk again and regain the ability to perform daily activities

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

Aim. Fungal orthopaedic infections most commonly affect people with complex surgical histories and existing comorbidities. Recurrence and re-infection rates are high, even with optimal surgical and systemic antifungal treatment. AmBisome liposomal amphotericin B has been suggested for local antifungal therapy, as an adjunctive treatment for fungal osteoarticular infections. Few case series have examined its clinical use when combined with polymethylmethacrylate cement PMMA), or with absorbable local antibiotic carriers. We aimed to evaluate the clinical use of local antifungal therapy with AmBisome liposomal amphotericin B (ABlaB), including tolerated doses, serious adverse events, and treatment outcomes. Method. A retrospective cohort of all patients treated with local antifungal therapy with ABlaB between January 2016 and January 2021 in a specialist orthopaedic hospital was identified using pharmacy records. Renal function, serious adverse events during treatment, surgical outcomes including spacer fracture and infection recurrence, were identified from electronic clinical records. The project was approved by the Institutional Review Board (clinical audit 6871). Results. 13 operations involving local antifungal therapy with ABlaB, in 12 patients, were identified. Eleven were infected with Candida species and one with Aspergillus. Mean follow-up was 22 months (range 4–46). Ten first stage arthroplasty revisions, 2 second stage arthroplasty revisions, and one debridement and removal of metalwork for fracture-related infection were performed. Locally implanted doses of ABlaB ranged from 100mg to 3600mg (50–400mg per 40g mix of PMMA). Six patients received ABlaB in absorbable antibiotic carriers containing calcium sulphate. This was noted to delay carrier setting. Patients were also given systemic antifungal therapy. No patients experienced serious adverse events related to toxicity from local antifungal therapy with ABlaB. There were no spacer fractures. Overall treatment success was 54% at final follow-up, although there were no recurrent fungal infections identified in patients experiencing treatment failure. Conclusions. Local antifungal therapy with liposomal amphotericin B, when combined with surgery and systemic therapy, appears to be a safe and well tolerated intervention in the management of complex fungal osteoarticular infections