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

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

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

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

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

Among all stem cell based clinical trials in the world, most of them are related to Mesenchymal Stem Cells whatever the tissue origin. Over time, the uses of cultured cells have increased greatly, particularly since 2009. Cells derived from adipose tissue are also increasingly used in trials compared with bone marrow cells. No real specificity emerged as to the therapeutic uses of the different types of stem cells and the more than half the MSC studies concerned allogeneic MSCs. With the maturation of this field, the requirements of relevant safety and potency cell control assays are now absolutely required for the future phase III and IV but quite different according to the autologous or allogenic setting. If for autologous setting, such assays have to be defined to identify MSC batches not to inject (for safety or lack of efficacy), in allogenic setting, potency assays are required to select the best donor with the maximum of safety. Up to now, most of assays are based on pre-clinical animal studies but need to be largely improved for a better relevance and accuracy. Their development stumbles on two difficulties: MSC themselves and our limited knowledge of their pleiotropic action mechanisms in conjunction with MTI regulatory rules. This indicates that we have to move from simple tests to multi-modal and combinatory approaches. We propose to discuss and illustrate these different points in view of the different clinical trials and how they inform us

Introduction. Today TKR is considered one of the most successful operative procedures in orthopedic surgery. Nevertheless, failure rates of 2 – 10% depending on the length of the study and the design are still reported. This provides evidence for further development in knee arthroplasty. Particularly the oxide ceramics used now in THA show major advantages due to their excellent tribological properties, their significantly reduced third-body wear as well as their high corrosion resistance. A further advantage of ceramic materials is their potential use in patients with metal allergy. Metallic wear induces immunological reactions resulting in hypersensitivity, pain, osteolysis and implant loosening. The purpose of our study was to examine the safety of the tibial component of a novel all-ceramic TKR. Materials and Methods. We tested the tibial components of the primary knee implant BPK-S Integration Ceramic. Both the tibial and the femoral component consist of BIOLOX®delta ceramic The standards ISO 14879-1 and ASTM F1800-07 describe the test set-up for the experimental fatigue strength testing of tibial components from knee implants. We conducted the testing with a significantly increased maximum load of 5,300 N (900 N are required). A final burst strength test was carried out after the fatigue load testing in the same embedding and with the same test set-up. Results. No specimen failed during fatigue load testing. The subsequent post-fatigue burst strength testing showed a maximum strength against fracture of at least 9.7 kN for size 3 and at least 12.1 kN for size 6. Discussion. The good results of the strength testing of the tibial component of the BPK-S Integration Ceramic tibial plateau supported the good initial clinical outcome without any implant specific complications of this knee design. Further clinical studies have to show if this design fulfills the high expectations over long periods of time

The posterolateral approach to ankle joint is well suited for ORIF of posterior malleolar fractures. There are no major neurovascular structures endangering this approach other than the sural nerve. The sural nerve is often used as an autologous peripheral nerve graft and provides sensation to the lateral aspect of the foot. Hence every attempt must be made to protect the sural nerve. The aim of this paper is to measure the precise distance of the sural nerve from surrounding soft tissue structures. This is a retrospective image review study including patients with MRI of their ankle from January 09 - Nov 2010. We indentified 78 MRI scans out of which 64 were deemed eligible for assessment. All measurements were made from Axial T1 slices. Measurements were made from the lateral aspect of the TA to the central of the sural nerve, central of sural nerve to the posterior aspect of the peronei muscles and central of the sural nerve to the posterior aspect of fibula. Data were collected on a Microsoft Excel spreadsheet and the descriptive statistics calculated. The key findings of the paper is the safety window for the sural nerve from the lateral border of TA is 7mm, 1.3cm and 2cm at 3 cm above ankle joint, at the ankle joint and at the distal tip of fibula respectively. Similarly the safety window for the nerve from the posterior aspect of fibula is 2cm, 1.6cm, 1.6cm at 3cm above ankle, at the ankle joint and the distal tip of fibula respectively. Our study demonstrates the close relationship of the nerve in relation to tendoachilles, peronei and fibula in terms of exact measurements. The safety margins established in this study should enable the surgeon in preventing endangerment of the sural nerve encountered in this approach

Anterior approach total hip arthroplasty (AA-THA) has a steep learning curve, with higher complication rates in initial cases. Proper surgical case selection during the learning curve can reduce early risk. This study aims to identify patient and radiographic factors associated with AA-THA difficulty using Machine Learning (ML).

Consecutive primary AA-THA patients from two centres, operated by two expert surgeons, were enrolled (excluding patients with prior hip surgery and first 100 cases per surgeon). K- means prototype clustering – an unsupervised ML algorithm – was used with two variables - operative duration and surgical complications within 6 weeks - to cluster operations into difficult or standard groups.

Radiographic measurements (neck shaft angle, offset, LCEA, inter-teardrop distance, Tonnis grade) were measured by two independent observers. These factors, alongside patient factors (BMI, age, sex, laterality) were employed in a multivariate logistic regression analysis and used for k-means clustering. Significant continuous variables were investigated for predictive accuracy using Receiver Operator Characteristics (ROC).

Out of 328 THAs analyzed, 130 (40%) were classified as difficult and 198 (60%) as standard. Difficult group had a mean operative time of 106mins (range 99–116) with 2 complications, while standard group had a mean operative time of 77mins (range 69–86) with 0 complications. Decreasing inter-teardrop distance (odds ratio [OR] 0.97, 95% confidence interval [CI] 0.95–0.99, p = 0.03) and right-sided operations (OR 1.73, 95% CI 1.10–2.72, p = 0.02) were associated with operative difficulty. However, ROC analysis showed poor predictive accuracy for these factors alone, with area under the curve of 0.56. Inter-observer reliability was reported as excellent (ICC >0.7).

Right-sided hips (for right-hand dominant surgeons) and decreasing inter-teardrop distance were associated with case difficulty in AA-THA. These data could guide case selection during the learning phase. A larger dataset with more complications may reveal further factors.

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.

Introduction

To face the problem of surgical complications, which is generally relevant in surgical fields, an intraoperative checklist (Safety Surgical Checklist, SSC) was elaborated and released by the World Health Organization in 2008, and its use has been described in 2009. In our Institution, the WHO SSC was introduced in 2011.

In spinal surgery, many preventive measures were investigated to reduce complications, but there is no report on the effectiveness of the WHO checklist in reducing complications.

Background

The Targon FN plate is a combination of the sliding hip screw and multiple cancellous screws. It is used in the fixation of intracapsular fractures of the neck of femur. The aim of this prospective audit was to assess clinical and radiological outcomes of Targon FN.

Regional anaesthetic for foot surgery has been discussed as a method of post operative analgesia. Ankle block as the sole anaesthetic for foot surgery has not been extensively reviewed in the literature.

We aimed to describe our experience of forefoot surgery under ankle block alone. 21 consecutive forefoot procedures (18 patients) were carried out under ankle block. The blocks were performed by the senior authors. A mixture of 10ml 2% Lidocaine with 10ml 0.5 % Bupivacaine was administered to the superficial peroneal, deep peroneal, sural and saphenous nerves. Ankle tourniquet was employed in all procedures. The patients were contacted post operatively and completed a standardised questionnaire including an incremented pain assessment ranging from 0-10 (0 no pain, 10 severe pain). 17 female and 1 male patients were contacted (age range 33-67y). Procedures included 13 first metatarsal osteotomies, 3 cheilectomies, 2 first MTP joint replacements, and 5 fusions. 14 patients requested a short acting sedative (midazolam). 5 patients (27 %) reported some discomfort during the block procedure (average pain score 1.2). No patients reported any pain during their operation(s). 4 patients (22%) required supplementation of the block. Average pain score at 6, 12, 24 and 48 hours following surgery were 0.66, 2.9, 2.4 and 1.3 respectively. All patients were discharged home and walking on the same day. None complained of nausea or required parenteral analgesia; there were no readmissions. Each patient confirmed they would have surgery under local block rather than general anaesthesia and would recommend this technique to family and friends.

Forefoot surgery under ankle block alone is safe and effective. Anaesthesia obtained permits the majority of forefoot procedures and provides lasting post-operative analgesia. Combined with intraoperative sedation, use of ankle tourniquet and same day discharge, it has very high patient acceptance and satisfaction.

Regional anaesthetic for foot surgery has been discussed as a method of post operative analgesia. Ankle block as the sole anaesthetic for foot surgery has not been extensively reviewed in the literature. We aimed to describe our experience of forefoot surgery under ankle block.

Sixty-six consecutive forefoot procedures (59 patients) were carried out under ankle block. Patients were contacted post operatively and completed a standardised questionnaire including an incremental pain assessment ranging from 0-10 (0 no pain, 10 severe pain).

Forty nine female and 10 male patients (age range 20-85y) were included. Procedures included 33 first metatarsal osteotomies, 15 cheilectomies, 3 first MTP joint replacements, 5 fusions, 4 excision of neuroma and 6 other procedures. 22 patients (33% of cases) reported discomfort during the block procedure (average pain score 1.5). 6 patients reported pain during their operation(s), average score 0.26. Average pain scores at 6, 12, 24 and 48 hours following surgery were 2.0, 3.2, 2.7 and 2.1 respectively. All patients were discharged home and walking on the same day. There were no readmissions. Each patient confirmed they would have surgery under regional block rather than general anaesthesia and would recommend this technique to family and friends.

There are many advantages in being able to perform these relatively small procedures under regional anaesthesia. The anaesthesia obtained permits the majority of forefoot procedures and provides lasting post-operative analgesia. Combined with intra-operative sedation, use of ankle tourniquet and same day discharge; it has very high patient acceptance and satisfaction.

Introduction. When designing a new osteosynthesis device, the biomechanical competence must be evaluated with respect to the acting loads. In a previous study, the loads on the proximal phalanx during rehabilitation exercises were calculated. This study aimed to assess the safety of a novel customizable osteosynthesis device compared to those loads to determine when failure would occur. Method. Forty proximal phalanges were dissected from skeletally mature female sheep and divided into four testing groups. A custom 3D printed cutting and drilling guide was used to create a reduced osteotomy and pilot holes to insert four 1.5 mm cortical screws. A novel light-curable polymer composite was used to fixate the bones with an in situ fixation patch. The constructs were tested in cyclic four-point bending in a bioreactor with ringer solution at 37°C with a valley load of 2 N. Four groups (N = 10) had increasing peak loads based on varying safety factors relative to the physiological loading (G1:100x, G2:150x, G3:175x, G4:250x). Each specimen was tested for 12,600 cycles (6 weeks of rehabilitation) or until failure occurred. After the test the thickness of the patch was measured with digital calipers and data analysis was performed in Python and R. Result. All samples survived in G1, and all failed in G4. G2 and G3 had 1 and 8 failures, respectively. There was no significant difference in patch thickness in all survivor samples against failures (p = 0.131), however, there was a significant difference in the displacement amplitude in the final cycle (0.072 mm vs. 0.15 mm; p < 0.001). Conclusion. This study found the survival and failure limits of a novel osteosynthesis device as a function of physiological loading. These results indicate that such fixations could withstand 100x the loading for typical non-weightbearing rehabilitation. Further studies are needed to confirm the safety for other conditions

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

Intra-articular injection is a common way to deliver biologics to joints, but their effectiveness is limited by rapid clearance from the joint space. This barrier can be overcome by genetically modifying cells within the joint such that they produce anti-arthritic gene products endogenously, thereby achieving sustained, therapeutic, intra-articular concentrations of the transgene products without re-dosing. A variety of non-viral and viral vectors have been subjected to preclinical testing to evaluate their suitability for delivering genes to joints. The first transfer of a gene to a human joint used an ex vivo protocol involving retrovirally transduced, autologous, synovial fibroblasts. Recent advances in vector technology allow in vivo delivery using adeno-associated virus (AAV). We have developed an AAV vector encoding the interleukin-1 receptor antagonist (AAV.IL-1Ra) for injection into joints with osteoarthritis (OA). It showed efficacy and safety in equine and rat models of OA, leading to a recently-completed, investigator-initiated, Phase I, dose-escalation clinical trial in 9 subjects with mid-stage OA of the knee (. ClinicalTrials.gov. Identifier: NCT02790723). Three cohorts of three subjects with mild to moderate OA in the index knee were injected intra-articularly under ultrasound guidance with a low (10e11 viral genomes) medium (10e12 viral genomes) or high (10e13 viral genomes) dose of AAV.IL-1Ra and followed for one year. The data confirm safety, with evidence of sustained intra-articular expression of IL-1Ra and a clinical response in certain subjects. Funding for a subsequent Phase Ib trial involving 50 subjects (. ClinicalTrials.gov. Identifier: NCT05835895), expected to start later this year, has been acquired. Progress in this area has stimulated commercial activity and there are now at least seven different companies developing gene therapies for OA and a number of clinical trials are in progress. Acknowledgement: Clinical trial funded by US Department of Defense Clinical Trial Award W81XWH-16-1-0540

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

Abstract. Objectives. Osteoporotic fractures tend to be more challenging than fractures in healthy bone and the efficacy of metal screw fixation decreases with decreasing bone mineral density making it more difficult for such screws to gain purchase. This leads to increased complication rates such as malunion, non-union and implant failure (1). Bioresorbable polymer devices have seen clinical success in fracture fixation and are a promising alternative for metallic devices but are rarely used in the osteoporotic population. To address this, we are developing a system that may allow osteoporotic patients to avail of bioresorbable devices (2) but it is important to establish if patients have any reservations about having a plastic resorbable device instead of a metal one. Therefore the aim of this study was to explore the acceptability of bioresorbable fracture fixation devices to people with osteoporosis. Methods. A cross sectional descriptive study was conducted in a UK wide population using convenience sampling. An online survey comprising nine survey questions and nine demographic questions was developed in Microsoft Teams and tested for face validity in a small pilot study (n=6). Following amendments and ethical approval, the survey was distributed by the Royal Osteoporosis Society on their website and social media platforms. People were invited to take part if they lived in the UK, were over 18 years old and had been diagnosed with osteoporosis. The survey was open for three weeks in May 2023. Responses were analysed using descriptive statistics. Results. There were 112 responses. Eight participants had not been diagnosed with osteoporosis and therefore did not meet the study criteria. Of the remaining 104, 102 were female and 2 were male and 102 were white (2 chose not to disclose their ethnicity). The majority of participants were aged 55–64 (34.6%) or 65–74 (37.5%), were college/university educated (38.5%) and had previously sustained a fragility fracture (52.9%). Only 3.9% of participants had heard of bioresorbable fracture fixation devices compared to 62.5% for metal devices. Most people were unsure if they would trust one type of device over the other (58.7%) and would ask for more information if their surgeon were to suggest using a bioresorbable device to fix their fracture (61.5%). The most commonly reported concerns were about device safety and efficacy: toxicity of the degradation products and the device breaking down too early before the fracture had healed. Two participants cited environmental concerns about increased use of plastics as a reason they would decline such a device. Conclusions. As expected, participants had little to no knowledge of bioresorbable polymer fixation devices. In general, they were willing to be guided by their surgeon but would require supporting information on the safety and efficacy of their long-term use. The results of this study show that it will be important to have relevant and understandable information to give patients when recommending these devices as treatments to ensure and support a shared-decision approach to patient care. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

The aim of the ongoing projects was to demonstrate the efficacy of autologous bone marrow derived stem cells (MSC) combined with biomaterial to induced new bone formation in a randomized multicenter controlled clinical trial. Patients with a need for bone reconstruction of residual edentulous ridges in both the mandible and maxilla due to bone defects with a vertical loss of alveolar bone volume and/or knife edge ridges (≤ than 4,5 mm) unable to provide adequate primary stabilization for dental implants were included in the clinical study. Autologous bone marrow MSC were expanded, loaded on BCP and used to augment the alveolar ridges. After five months bone biopsies were harvested at the implant position site and implants were installed in the regenerated bone. The implants were loaded after 8–12 weeks. Safety, efficacy, quality of life and success/survival were assessed. Five clinical centers, 4 different countries participated. Bone grafts harvested from the ramus of the mandibles were used as control in the projects