Sex Differences in Patient-rated Outcomes After Lumbar Spinal Fusion for Degenerative Disease: A Multicenter Cohort Study.

STUDY DESIGN: Heterogeneous data collection via a mix of prospective, retrospective, and ambispective methods. OBJECTIVE: To evaluate the effect of biological sex on patient-reported outcomes after spinal fusion surgery for lumbar degenerative disease. SUMMARY OF BACKGROUND DATA: Current literature suggests sex differences regarding clinical outcome after spine surgery may exist. Substantial methodological heterogeneity and limited comparability of studies warrants further investigation of sex-related differences in treatment outcomes. METHODS: We analyzed patients who underwent spinal fusion with or without pedicle screw insertion for lumbar degenerative disease included within a multinational study, comprising patients from 11 centers in 7 countries. Absolute values and change scores (change from pe-operative baseline to post-operative follow-up) for 12-month functional impairment (Oswestry disability index [ODI]) and back and leg pain severity (numeric rating scale [NRS]) were compared between male and female patients. Minimum clinically important difference (MCID) was defined as > 30% improvement. RESULTS: Six-hundred-sixty (59%) of 1115 included patients were female. Female patients presented with significantly baseline ODI (51.5 ± 17.2 vs. 47.8 ± 17.9, P<0.001) and back pain (6.96 ± 2.32 vs. 6.60 ± 2.30, P=0.010) and leg pain (6.49 ± 2.76 vs. 6.01 ± 2.76, P=0.005). At 12-months, female patients still reported significantly higher ODI (22.76 ± 16.97 vs. 20.50 ± 16.10, P=0.025), but not higher back (3.13 ± 2.38 vs. 3.00 ± 2.40, P=0.355) or leg pain (2.62 ± 2.55 vs. .34 ± 2.43, P=0.060). Change scores at 12 months did not differ significantly among male and female patients in ODI (∆ 1.31, 95% CI -3.88-1.25, P=0.315), back (∆ 0.22, 95% CI -0.57-0.12, P=0.197) and leg pain (∆ 0.16, 95% CI -0.56-0.24, P=0.439). MCID at 12-months was achieved in 330 (77.5%) male patients and 481 (76.3%) female patients (P=0.729) for ODI. CONCLUSION: Both sexes experienced a similar benefit from surgery in terms of relative improvement in scores for functional impairment and pain. Although female patients reported a higher degree of functional impairment and pain preoperatively, at 12 months only their average scores for functional impairment remained higher than those for their male counterparts, while absolute pain scores were similar for female and male patients.

SafeRPlan: Safe deep reinforcement learning for intraoperative planning of pedicle screw placement.

Spinal fusion surgery requires highly accurate implantation of pedicle screw implants, which must be conducted in critical proximity to vital structures with a limited view of the anatomy. Robotic surgery systems have been proposed to improve placement accuracy. Despite remarkable advances, current robotic systems still lack advanced mechanisms for continuous updating of surgical plans during procedures, which hinders attaining higher levels of robotic autonomy. These systems adhere to conventional rigid registration concepts, relying on the alignment of preoperative planning to the intraoperative anatomy. In this paper, we propose a safe deep reinforcement learning (DRL) planning approach (SafeRPlan) for robotic spine surgery that leverages intraoperative observation for continuous path planning of pedicle screw placement. The main contributions of our method are (1) the capability to ensure safe actions by introducing an uncertainty-aware distance-based safety filter; (2) the ability to compensate for incomplete intraoperative anatomical information, by encoding a-priori knowledge of anatomical structures with neural networks pre-trained on pre-operative images; and (3) the capability to generalize over unseen observation noise thanks to the novel domain randomization techniques. Planning quality was assessed by quantitative comparison with the baseline approaches, gold standard (GS) and qualitative evaluation by expert surgeons. In experiments with human model datasets, our approach was capable of achieving over 5% higher safety rates compared to baseline approaches, even under realistic observation noise. To the best of our knowledge, SafeRPlan is the first safety-aware DRL planning approach specifically designed for robotic spine surgery.

The Expression of Toll-like Receptors in Cartilage Endplate Cells: A Role of Toll-like Receptor 2 in Pro-Inflammatory and Pro-Catabolic Gene Expression.

INTRODUCTION: The vertebral cartilage endplate (CEP), crucial for intervertebral disc health, is prone to degeneration linked to chronic low back pain, disc degeneration, and Modic changes (MC). While it is known that disc cells express toll-like receptors (TLRs) that recognize pathogen- and damage-associated molecular patterns (PAMPs and DAMPs), it is unclear if CEP cells (CEPCs) share this trait. The CEP has a higher cell density than the disc, making CEPCs an important contributor. This study aimed to identify TLRs on CEPCs and their role in pro-inflammatory and catabolic gene expression. METHODS: Gene expression of TLR1-10 was measured in human CEPs and expanded CEPCs using quantitative polymerase chain reaction. Additionally, surface TLR expression was measured in CEPs grouped into non-MC and MC. CEPCs were stimulated with tumor necrosis factor alpha, interleukin 1 beta, small-molecule TLR agonists, or the 30 kDa N-terminal fibronectin fragment. TLR2 signaling was inhibited with TL2-C29, and TLR2 protein expression was measured with flow cytometry. RESULTS: Ex vivo analysis found all 10 TLRs expressed, while cultured CEPCs lost TLR8 and TLR9 expression. TLR2 expression was significantly increased in MC1 CEPCs, and its expression increased significantly after pro-inflammatory stimulation. Stimulation of the TLR2/6 heterodimer upregulated TLR2 protein expression. The TLR2/1 and TLR2/6 ligands upregulated pro-inflammatory genes and matrix metalloproteases (MMP1, MMP3, and MMP13), and TLR2 inhibition inhibited their upregulation. Endplate resorptive capacity of TLR2 activation was confirmed in a CEP explant model. CONCLUSIONS: The expression of TLR1-10 in CEPCs suggests that the CEP is susceptible to PAMP and DAMP stimulation. Enhanced TLR2 expression in MC1, and generally in CEPCs under inflammatory conditions, has pro-inflammatory and pro-catabolic effects, suggesting a potential role in disc degeneration and MC.

Titanium-Coated Polyetheretherketone Cages Vs Full Titanium Cages for Stand-Alone 1- or 2-Level Anterior Cervical Discectomy and Fusion: A Comparative Study.

BACKGROUND: Anterior cervical discectomy and fusion (ACDF) for the surgical treatment of cervical degenerative disease often includes an intervertebral cage, which restores disc height and lordosis while promoting fusion . Cage materials include titanium (TTN) or polyetheretherketone (PEEK). Controversy in material selection stems from higher fusion rates with TNN, despite a higher subsidence rate, while PEEK cages demonstrate superior preservation of interspace height. Combining the advantages of both materials, TTN-coated PEEK (TCPEEK) cages were developed, featuring a PEEK core with similar stiffness to the bone, enveloped with a TTN coat, improving osteointegration. However, the potential superiority of TCPEEK over TTN cages has not been investigated. This study aimed to compare clinical and radiographic outcomes following single- or double-level ACDF using either TTN or TCPEEK cages. METHODS: This retrospective single-center study included patients undergoing single- or double-level ACDF between 2017 and 2019. Clinical outcomes included the Neck Disability Index and revision surgery incidence. Radiographic parameters included cervical and segmental lordosis, C2 to C7 sagittal vertical axis, fusion, subsidence, and adjacent segment degeneration at a minimum 12-month follow-up. RESULTS: A total of 45 patients (16 TTN; 29 TCPEEK) and 58 cervical levels (21 TTN; 37 TCPEEK) were included. Both cages significantly improved Neck Disability Index scores (TTN -10.0; TCPEEK -14.1) without significant differences. Two single-level TCPEEK patients required revision surgery due to non-union. In the radiological assessments, no significant difference was found for subsidence rates (TTN 52.4%; TCPEEK 56.8%), adjacent segment degeneration, cervical and segmental lordosis, and changes in C2 to C7 sagittal vertical axis. Though not statistically significant, fusion rates trended slightly higher with TTN (90.5%) vs TCPEEK cages (86.5%). CONCLUSION: TTN and TCPEEK cages achieve satisfactory clinical and radiological outcomes in single- or double-level ACDF. This finding suggests that the choice between them can be based on other factors, such as surgeon preference or availability, rather than specific material properties. CLINICAL RELEVANCE: This study found that the selection of ACDF cage material did not affect clinical outcomes.

Multicenter external validation of prediction models for clinical outcomes after spinal fusion for lumbar degenerative disease.

BACKGROUND: Clinical prediction models (CPM), such as the SCOAP-CERTAIN tool, can be utilized to enhance decision-making for lumbar spinal fusion surgery by providing quantitative estimates of outcomes, aiding surgeons in assessing potential benefits and risks for each individual patient. External validation is crucial in CPM to assess generalizability beyond the initial dataset. This ensures performance in diverse populations, reliability and real-world applicability of the results. Therefore, we externally validated the tool for predictability of improvement in oswestry disability index (ODI), back and leg pain (BP, LP). METHODS: Prospective and retrospective data from multicenter registry was obtained. As outcome measure minimum clinically important change was chosen for ODI with ≥ 15-point and ≥ 2-point reduction for numeric rating scales (NRS) for BP and LP 12 months after lumbar fusion for degenerative disease. We externally validate this tool by calculating discrimination and calibration metrics such as intercept, slope, Brier Score, expected/observed ratio, Hosmer-Lemeshow (HL), AUC, sensitivity and specificity. RESULTS: We included 1115 patients, average age 60.8 ± 12.5 years. For 12-month ODI, area-under-the-curve (AUC) was 0.70, the calibration intercept and slope were 1.01 and 0.84, respectively. For NRS BP, AUC was 0.72, with calibration intercept of 0.97 and slope of 0.87. For NRS LP, AUC was 0.70, with calibration intercept of 0.04 and slope of 0.72. Sensitivity ranged from 0.63 to 0.96, while specificity ranged from 0.15 to 0.68. Lack of fit was found for all three models based on HL testing. CONCLUSIONS: Utilizing data from a multinational registry, we externally validate the SCOAP-CERTAIN prediction tool. The model demonstrated fair discrimination and calibration of predicted probabilities, necessitating caution in applying it in clinical practice. We suggest that future CPMs focus on predicting longer-term prognosis for this patient population, emphasizing the significance of robust calibration and thorough reporting.

Bone marrow stromal cells in Modic type 1 changes promote neurite outgrowth.

The pain in patients with Modic type 1 changes (MC1) is often due to vertebral body endplate pain, which is linked to abnormal neurite outgrowth in the vertebral body and adjacent endplate. The aim of this study was to understand the role of MC1 bone marrow stromal cells (BMSCs) in neurite outgrowth. BMSCs can produce neurotrophic factors, which have been shown to be pro-fibrotic in MC1, and expand in the perivascular space where sensory vertebral nerves are located. The study involved the exploration of the BMSC transcriptome in MC1, co-culture of MC1 BMSCs with the neuroblastoma cell line SH-SY5Y, analysis of supernatant cytokines, and analysis of gene expression changes in co-cultured SH-SY5Y. Transcriptomic analysis revealed upregulated brain-derived neurotrophic factor (BDNF) signaling-related pathways. Co-cultures of MC1 BMSCs with SH-SY5Y cells resulted in increased neurite sprouting compared to co-cultures with control BMSCs. The concentration of BDNF and other cytokines supporting neuron growth was increased in MC1 vs. control BMSC co-culture supernatants. Taken together, these findings show that MC1 BMSCs provide strong pro-neurotrophic cues to nearby neurons and could be a relevant disease-modifying treatment target.

Development and evaluation of robot-assisted ultrasound navigation system for pedicle screw placement: An ex-vivo animal validation.

PURPOSE: Spinal instrumentation with pedicle screw placement (PSP) is an important surgical technique for spinal diseases. Accurate screw trajectory is a prerequisite for PSP. Ultrasound (US) imaging with robot-assisted system forms a non-radiative alternative to provide precise screw trajectory. This study reports on the development and assessment of US navigation for this application. METHODS: A robot-assisted US reconstruction was proposed and an automatic CT-to-US registration algorithm was investigated, allowing the registration of screw trajectories. Experiments were conducted on ex-vivo lamb spines to evaluate system performance. RESULTS: In total, 72 screw trajectories are measured, displaying an average position accuracy of 2.80 ± 1.14 mm and orientation accuracy of 1.38 ± 0.61°. CONCLUSION: The experimental results demonstrate the feasibility of proposed US system. This work, although restricted to laboratory settings, encourages further exploration of the potential of this technology in clinical practice.

Automatic breach detection during spine pedicle drilling based on vibroacoustic sensing.

Pedicle drilling is a complex and critical spinal surgery task. Detecting breach or penetration of the surgical tool to the cortical wall during pilot-hole drilling is essential to avoid damage to vital anatomical structures adjacent to the pedicle, such as the spinal cord, blood vessels, and nerves. Currently, the guidance of pedicle drilling is done using image-guided methods that are radiation intensive and limited to the preoperative information. This work proposes a new radiation-free breach detection algorithm leveraging a non-visual sensor setup in combination with deep learning approach. Multiple vibroacoustic sensors, such as a contact microphone, a free-field microphone, a tri-axial accelerometer, a uni-axial accelerometer, and an optical tracking system were integrated into the setup. Data were collected on four cadaveric human spines, ranging from L5 to T10. An experienced spine surgeon drilled the pedicles relying on optical navigation. A new automatic labeling method based on the tracking data was introduced. Labeled data was subsequently fed to the network in mel-spectrograms, classifying the data into breach and non-breach. Different sensor types, sensor positioning, and their combinations were evaluated. The best results in breach recall for individual sensors could be achieved using contact microphones attached to the dorsal skin (85.8%) and uni-axial accelerometers clamped to the spinous process of the drilled vertebra (81.0%). The best-performing data fusion model combined the latter two sensors with a breach recall of 98%. The proposed method shows the great potential of non-visual sensor fusion for avoiding screw misplacement and accidental bone breaches during pedicle drilling and could be extended to further surgical applications.

Prognostic value of clinical and MRI features in the screening of lipomatous lesions.

BACKGROUND AND OBJECTIVES: Differentiation of lipomatous tumors mostly requires diagnostic biopsy but is essential to decide for the most adequate therapy. This study aims to investigate the prognostic value of available clinical and radiological features with regard to malignancy of the lesion, recurrence and survival. METHODS: In this retrospective cohort study, 104 patients with a biopsy-proven lipomatous tumor between 2010 and 2015 and a minimum clinical follow-up of two years were enrolled. Next to clinical features (age, gender, location of the lesion, histopathologic diagnosis, stage of disease, time to recurrence and death), MRI parameters were recorded retrospectively and blinded to the histological diagnosis. RESULTS: Malignant lipomatous tumors were associated with location in the lower extremities and MRI features like thick septation (>2 mm), presence of a non-adipose mass, foci of high T2/STIR signal and contrast agent enhancement. A non-adipose mass was a predictor for recurrence and inferior overall survival, while lesions with high T2/STIR signal showed higher risk of recurrence only. In combination, clinical and radiological features (lower extremities, septation > 2 mm, existence of non-adipose mass, contrast enhancement, and foci of high T2/STIR signal) predicted a malignant lipomatous tumor with an accuracy of 0.941 (95% CI of 0.899-0.983; 87% sensitivity, 86% specificity). CONCLUSION: Localization and characteristic MR features predict malignancy in most lipomatous lesions. Non-adipose masses are a poor prognostic factor, being associated with tumor recurrence and disease-related death.

Robot-assisted ultrasound reconstruction for spine surgery: from bench-top to pre-clinical study.

PURPOSE: Robot-assisted ultrasound (rUS) systems have already been used to provide non-radiative three-dimensional (3D) reconstructions that form the basis for guiding spine surgical procedures. Despite promising studies on this technology, there are few studies that offer insight into the robustness and generality of the approach by verifying performance in various testing scenarios. Therefore, this study aims at providing an assessment of a rUS system, with technical details from experiments starting at the bench-top to the pre-clinical study. METHODS: A semi-automatic control strategy was proposed to ensure continuous and smooth robotic scanning. Next, a U-Net-based segmentation approach was developed to automatically process the anatomic features and derive a high-quality 3D US reconstruction. Experiments were conducted on synthetic phantoms and human cadavers to validate the proposed approach. RESULTS: Average deviations of scanning force were found to be 2.84±0.45 N on synthetic phantoms and to be 5.64±1.10 N on human cadavers. The anatomic features could be reliably reconstructed at mean accuracy of 1.28±0.87 mm for the synthetic phantoms and of 1.74±0.89 mm for the human cadavers. CONCLUSION: The results and experiments demonstrate the feasibility of the proposed system in a pre-clinical setting. This work is complementary to previous work, encouraging further exploration of the potential of this technology in in vivo studies.

Modic type 2 changes are fibroinflammatory changes with complement system involvement adjacent to degenerated vertebral endplates.

Background: Vertebral endplate signal intensity changes visualized by magnetic resonance imaging termed Modic changes (MC) are highly prevalent in low back pain patients. Interconvertibility between the three MC subtypes (MC1, MC2, MC3) suggests different pathological stages. Histologically, granulation tissue, fibrosis, and bone marrow edema are signs of inflammation in MC1 and MC2. However, different inflammatory infiltrates and amount of fatty marrow suggest distinct inflammatory processes in MC2. Aims: The aims of this study were to investigate (i) the degree of bony (BEP) and cartilage endplate (CEP) degeneration in MC2, (ii) to identify inflammatory MC2 pathomechanisms, and (iii) to show that these marrow changes correlate with severity of endplate degeneration. Methods: Pairs of axial biopsies (n = 58) spanning the entire vertebral body including both CEPs were collected from human cadaveric vertebrae with MC2. From one biopsy, the bone marrow directly adjacent to the CEP was analyzed with mass spectrometry. Differentially expressed proteins (DEPs) between MC2 and control were identified and bioinformatic enrichment analysis was performed. The other biopsy was processed for paraffin histology and BEP/CEP degenerations were scored. Endplate scores were correlated with DEPs. Results: Endplates from MC2 were significantly more degenerated. Proteomic analysis revealed an activated complement system, increased expression of extracellular matrix proteins, angiogenic, and neurogenic factors in MC2 marrow. Endplate scores correlated with upregulated complement and neurogenic proteins. Discussion: The inflammatory pathomechanisms in MC2 comprises activation of the complement system. Concurrent inflammation, fibrosis, angiogenesis, and neurogenesis indicate that MC2 is a chronic inflammation. Correlation of endplate damage with complement and neurogenic proteins suggest that complement system activation and neoinnervation may be linked to endplate damage. The endplate-near marrow is the pathomechanistic site, because MC2 occur at locations with more endplate degeneration. Conclusion: MC2 are fibroinflammatory changes with complement system involvement which occur adjacent to damaged endplates.

Role of C-reactive protein in the bone marrow of Modic type 1 changes.

Modic type 1 changes (MC1) are vertebral bone marrow lesions and associate with low back pain. Increased serum C-reactive protein (CRP) has inconsistently been associated with MC1. We aimed to provide evidence for the role of CRP in the tissue pathophysiology of MC1 bone marrow. From 13 MC1 patients undergoing spinal fusion at MC1 levels, vertebral bone marrow aspirates from MC1 and intrapatient control bone marrow were taken. Bone marrow CRP, interleukin (IL)-1, and IL-6 were measured with enzyme-linked immunosorbent assays; lactate dehydrogenase (LDH) was measured with a colorimetric assay. CRP, IL-1, and IL-6 were compared between MC1 and control bone marrow. Bone marrow CRP was correlated with blood CRP and with bone marrow IL-1, IL-6, and LDH. CRP expression by marrow cells was measured with a polymerase chain reaction. Increased CRP in MC1 bone marrow (mean difference: +0.22 mg CRP/g, 95% confidence interval [CI] [-0.04, 0.47], p = 0.088) correlated with blood CRP (r = 0.69, p = 0.018), with bone marrow IL-1ß (ρ = 0.52, p = 0.029) and IL-6 (ρ = 0.51, p = 0.031). Marrow cells did not express CRP. Increased LDH in MC1 bone marrow (143.1%, 95% CI [110.7%, 175.4%], p = 0.014) indicated necrosis. A blood CRP threshold of 3.2 mg/L detected with 100% accuracy increased CRP in MC1 bone marrow. In conclusion, the association of CRP with inflammatory and necrotic changes in MC1 bone marrow provides evidence for a pathophysiological role of CRP in MC1 bone marrow.

CD90-positive stromal cells associate with inflammatory and fibrotic changes in modic changes.

Objective: Modic changes (MC) are vertebral bone marrow lesions seen on magnetic resonance images, that associate with disc degeneration and low back pain (LBP). Few studies described MC histopathology qualitatively based on a few patient samples. CD90-positive bone marrow stromal cells were shown to be pro-fibrotic in MC. We aimed to provide the first semi-quantitative histomorphometric analysis of MC bone marrow. We hypothesized a role of CD90-positive cells in MC pathomechanisms. Design: Human biopsies from Modic type 1 changes (MC1, n â€‹= â€‹8), Modic type 2 changes (MC2, n â€‹= â€‹6), and control biopsies (MC0, n â€‹= â€‹8) from adjacent vertebrae were obtained from 14 LBP patients during lumbar spinal fusion. Biopsies were processed for histology/immunohistochemistry. Inflammatory changes (oedema, inflammatory infiltrates), fibrotic changes (connective tissue, type I and III collagen, fibronectin, α-smooth muscle actin), and amount of bone marrow stromal cells (CD90, CD105) were scored. Scores for MC0, MC1, and MC2 were compared with non-parametric tests. Pairwise correlations, hierarchical clustering, and principal component analysis of histological readouts were calculated to identify most important histomorphometric MC characteristics. Results: Compared to MC0, MC1 had more connective tissue, oedema, inflammatory infiltrates, and CD90+ cells. MC2 compared to MC0 had more oedema and CD90+ cells. Scores of CD90 correlated and clustered with inflammatory and fibrotic changes. Amount of connective tissue correlated with LBP. Conclusion: Accumulation of CD90+ cells is a major characteristic of MC in patients undergoing lumbar spinal fusion and associates with inflammatory and fibrotic changes. Therefore, CD90+ cells may play an important role in the inflammatory-fibrotic pathomechanisms of MC.

Intraoperative tissue classification methods in orthopedic and neurological surgeries: A systematic review.

Accurate tissue differentiation during orthopedic and neurological surgeries is critical, given that such surgeries involve operations on or in the vicinity of vital neurovascular structures and erroneous surgical maneuvers can lead to surgical complications. By now, the number of emerging technologies tackling the problem of intraoperative tissue classification methods is increasing. Therefore, this systematic review paper intends to give a general overview of existing technologies. The review was done based on the PRISMA principle and two databases: PubMed and IEEE Xplore. The screening process resulted in 60 full-text papers. The general characteristics of the methodology from extracted papers included data processing pipeline, machine learning methods if applicable, types of tissues that can be identified with them, phantom used to conduct the experiment, and evaluation results. This paper can be useful in identifying the problems in the current status of the state-of-the-art intraoperative tissue classification methods and designing new enhanced techniques.

Long-term outcome of patients with adolescent idiopathic scoliosis seeking nonoperative treatment after a mean follow-up of 42 years.

PURPOSE: Adolescent idiopathic scoliosis (AIS) affects up to 3% of otherwise healthy adolescents. The extreme long-term outcomes of nonoperative treatment are underreported. This study aimed to investigate the long-term outcome of nonoperative-treated AIS patients. Comparison between a bracing and an observation approach were performed. METHODS: In a retrospective cohort study, 20 nonoperatively treated AIS patients were observed concerning patient-related outcome measures (PROM) (visual analog scale (VAS), Short Form Health Survey 36 item (SF 36), Scoliosis Research Society (SRS 24), Oswestry Low Back Pain Disability Index (ODI), Psychological General Well-Being Index (PGWBI)), radiological curve progression and health-related quality of life (HRQoL). Baseline characteristics and radiological imaging were collected. At follow-up, anteroposterior and lateral X-rays as well as questionnaires were analyzed. RESULTS: Twenty patients (16 females, mean age: 14.6 ± 3.2 years) with a follow-up time of 42 ± 9 years were included. Nine patients (initial Cobb 35° ± 19°) were treated with bracing for a mean time of 26 ± 9 months, while the other 11 patients (initial Cobb 29° ± 11°) were observed. The primary curve progressed from 32° ± 15° to 52° ± 25° in average with no significant difference between the cohorts (p = 0.371). At final follow-up, a mean ODI score of 7 ± 7.9 points with no difference depending on the treatment (p = 0.668) was seen. No significant differences were observed for PROMs. Curve magnitude correlated neither at diagnosis (p = 0.617) nor at follow-up (p = 0.535) with the ODI score at final follow-up. CONCLUSION: After a mean of 42 years, patients with nonoperative treatment of moderate AIS demonstrated a good clinical outcome despite progression of the deformity. LEVEL OF EVIDENCE: Level IV, therapeutic study.

A systematic analysis of preprints in Trauma & Orthopaedic surgery.

AIMS: Preprint servers allow authors to publish full-text manuscripts or interim findings prior to undergoing peer review. Several preprint servers have extended their services to biological sciences, clinical research, and medicine. The purpose of this study was to systematically identify and analyze all articles related to Trauma & Orthopaedic (T&O) surgery published in five medical preprint servers, and to investigate the factors that influence the subsequent rate of publication in a peer-reviewed journal. METHODS: All preprints covering T&O surgery were systematically searched in five medical preprint servers (medRxiv, OSF Preprints, Preprints.org, PeerJ, and Research Square) and subsequently identified after a minimum of 12 months by searching for the title, keywords, and corresponding author in Google Scholar, PubMed, Scopus, Embase, Cochrane, and the Web of Science. Subsequent publication of a work was defined as publication in a peer-reviewed indexed journal. The rate of publication and time to peer-reviewed publication were assessed. Differences in definitive publication rates of preprints according to geographical origin and level of evidence were analyzed. RESULTS: The number of preprints increased from 2014 to 2020 (p < 0.001). A total of 38.6% of the identified preprints (n = 331) were published in a peer-reviewed indexed journal after a mean time of 8.7 months (SD 5.4 (1 to 27)). The highest proportion of missing subsequent publications was in the preprints originating from Africa, Asia/Middle East, and South America, or in those that covered clinical research with a lower level of evidence (p < 0.001). CONCLUSION: Preprints are being published in increasing numbers in T&O surgery. Depending on the geographical origin and level of evidence, almost two-thirds of preprints are not subsequently published in a peer-reviewed indexed journal after one year. This raises major concerns regarding the dissemination and persistence of potentially wrong scientific work that bypasses peer review, and the orthopaedic community should discuss appropriate preventive measures.Cite this article: Bone Jt Open 2022;3(7):582-588.

Fixation of distal clavicle fractures with coracoclavicular instability: a comparative biomechanical study in human cadavers.

BACKGROUND: The need for coracoclavicular (CC) stabilization in the fixation of fractures with CC instability (Neer type IIB and V) was biomechanically demonstrated by higher construct strength than isolated locking plate osteosynthesis. It was the purpose of this study to prove noninferiority of the new cow-hitch suture repair technique compared with the well-established suture tape double-button fixation with regard to overall fixation strength and cyclic loading properties. METHODS: Twelve human cadaver shoulders (7 right and 5 left) were matched for sex and age (mean age: 75 ± 5 years). An oblique parasagittal fracture line 20 mm medial to the acromioclavicular joint line was created, and the CC ligaments were dissected. Six shoulders were reconstructed by a double FiberTape fixation with two suture buttons (group DB), and the remaining six shoulders by a cow-hitch suture repair using a double FiberWire with only coracoid button fixation (group CH). Both reconstruction techniques were tested in a servo-hydraulic material testing machine for cyclic displacement (mm), stiffness (N/mm), and maximum load-to-failure (N) after 500 cycles at 3 mm/s and inferosuperior load between 15 and 70 N. Superior fragment displacement in space was recorded using a MicroScribe digitizer. RESULTS: There were no statistically significant differences regarding cyclic displacement (group DB: 0.7 mm; group CH: 1.3 mm; P = .36), stiffness (group DB: 177 N/mm; group CH: 116 N/mm; P = .17), maximum load-to-failure (group DB: 560 N; group CH: 492 N; P = .59), and superior displacement in space of the medial fragment (group DB: 3.2 mm; group CH: 1.6 mm; P = .48). CONCLUSION: Fixation of unstable distal clavicle fractures using a double FiberWire cow-hitch suture repair with isolated coracoid button fixation for stand-alone CC stabilization resulted in similar biomechanical properties to a double-suture button fixation with FiberTapes while avoiding prominent clavicular implants.

FUSE-ML: development and external validation of a clinical prediction model for mid-term outcomes after lumbar spinal fusion for degenerative disease.

BACKGROUND: Indications and outcomes in lumbar spinal fusion for degenerative disease are notoriously heterogenous. Selected subsets of patients show remarkable benefit. However, their objective identification is often difficult. Decision-making may be improved with reliable prediction of long-term outcomes for each individual patient, improving patient selection and avoiding ineffective procedures. METHODS: Clinical prediction models for long-term functional impairment [Oswestry Disability Index (ODI) or Core Outcome Measures Index (COMI)], back pain, and leg pain after lumbar fusion for degenerative disease were developed. Achievement of the minimum clinically important difference at 12 months postoperatively was defined as a reduction from baseline of at least 15 points for ODI, 2.2 points for COMI, or 2 points for pain severity. RESULTS: Models were developed and integrated into a web-app ( https://neurosurgery.shinyapps.io/fuseml/ ) based on a multinational cohort [N = 817; 42.7% male; mean (SD) age: 61.19 (12.36) years]. At external validation [N = 298; 35.6% male; mean (SD) age: 59.73 (12.64) years], areas under the curves for functional impairment [0.67, 95% confidence interval (CI): 0.59-0.74], back pain (0.72, 95%CI: 0.64-0.79), and leg pain (0.64, 95%CI: 0.54-0.73) demonstrated moderate ability to identify patients who are likely to benefit from surgery. Models demonstrated fair calibration of the predicted probabilities. CONCLUSIONS: Outcomes after lumbar spinal fusion for degenerative disease remain difficult to predict. Although assistive clinical prediction models can help in quantifying potential benefits of surgery and the externally validated FUSE-ML tool may aid in individualized risk-benefit estimation, truly impacting clinical practice in the era of "personalized medicine" necessitates more robust tools in this patient population.

Acromioclavicular joint stabilization with a double cow-hitch technique compared to a double tight-rope: a biomechanical study.

INTRODUCTION: The aim of the present biomechanical study was to evaluate the stability of a novel simple and cost-effective mini-open double cow-hitch suture button technique of acromioclavicular (AC) joint stabilization in comparison to a well-established double tight-rope technique. MATERIALS AND METHODS: A total of 12 fresh-frozen cadaveric shoulders were randomized into two treatment groups. In either a coracoclavicular stabilization with a standard double tight-rope technique (Group 1; n = 6, age 78 years ± 10) or a double cow-hitch with two No. 5 FiberWire strains looped in a bicortical button placed at the bottom of the coracoid process (Group 2; n = 6, age 80 years ± 13). Both techniques were equally augmented with an AC joint cerclage using a FiberTape. All shoulders were tested in a servo-hydraulic material testing machine for elongation/cyclic displacement (in mm) after cyclic loading (70 N cyclical load, 1500 cycles), stiffness (N/mm) and ultimate load to failure (N). The mechanism of failure was recorded. All tests were performed in a previously published testing setup. RESULTS: After 1500 cycles, group 2 showed a cyclic displacement of 1.67 mm (SD 0.85), compared to 1.04 mm (SD 0.23) cyclic displacement in group 1 (p = 0.11). The cyclic displacement after AC reconstruction in group 1 was 0.36 mm lower than in the native state with intact ligaments (p = 0.19), whereas the cyclic elongation in group 2 was 0.05 mm higher compared to the native situation (p = 0.87). Stiffness after reconstruction was significantly higher in group 1 compared to the native specimen (p = 0.001), in group 2 it was similar as before the reconstruction (p = 0.64). Ultimate load to failure and stiffness were higher in group 1 with 424 N (SD 237) and 68.6 N/mm (SD 8.2), compared to 377 N (SD 152) and 68 N/mm (SD 13.3) in group 2, without reaching statistical significance (p = 0.69 and 0.89). The most common failure modes were clavicular fractures at the tight rope drill holes (n = 2) and clavicular fractures medially at the fixation site (n = 2) in group 1, and coracoid button break-through (n = 3) and clavicular fractures medially at the fixation site (n = 2) in group 2. CONCLUSIONS: Stabilization of the AC joint with a novel mini-open double cow-hitch suture button technique resulted in a similar low elongation, high stiffness and ultimate load to failure compared to a double tight-rope technique. This cost-effective technique for AC joint stabilization could demonstrate a sufficient biomechanical stability with especially high stiffness and load-to-failure. LEVEL OF EVIDENCE: Biomechanical study.

Risk factor analysis for above-knee amputation in patients with periprosthetic joint infection of the knee: a case-control study.

BACKGROUND: Periprosthetic joint infection (PJI) is a severe complication following knee arthroplasty. Therapeutic strategies comprise a combination of surgical and antibiotic treatment modalities and aim to eradicate the infection. Sometimes control of the disease can only be attained by above-knee amputation (AKA). While a vast amount of literature exists illuminating predisposing factors for PJI, risk factors favoring the endpoint AKA in this context are sparsely known. METHODS: The purpose of this investigation was to delineate whether patients with PJI of the knee present specific risk factors for AKA. In a retrospective case-control study 11 cases of PJI treated with AKA were compared to 57 cases treated with limb salvage (LS). The minimum follow-up was 2 years. Comorbidities, signs and symptoms of the current infection, factors related to previous surgeries and the implant, microbiology, as well as therapy related factors were recorded. Comparative analysis was performed using student's t-test, chi-square test or Fisher's exact test. Binary differences were calculated using odds ratio (OR). Reoperation frequency was compared using Mann-Whitney U test. In-depth descriptive analysis of 11 amputees was carried out. RESULTS: A total of 68 cases aged 71 ± 11.2 years were examined, 11 of which underwent AKA and 57 had LS. Severe comorbidities (p = 0.009), alcohol abuse (p = 0.015), and preoperative anemia (p = 0.022) were more frequently associated with AKA. Preoperative anemia was found in all 11 amputees (100%) and in 33 of 57 LS patients (58%) with an average preoperative hemoglobin of 99.9 ± 15.1 g/dl compared to 118.2 ± 19.9 g/dl (p = 0.011). No other parameters differed significantly. AKA patients underwent a median of eight (range 2-24) reoperations, LS patients a median of five (range 2-15). CONCLUSION: Factors potentially influencing the outcome of knee PJI are diverse. The indication of AKA in this context remains a rarity and a case-by-case decision. Patient-intrinsic systemic factors such as alcohol abuse, severe comorbidities and preoperative anemia may elevate the individual risk for AKA in the setting of PJI. We recommend that anemia, being a condition well amenable to therapeutic measures, should be given special consideration in management of PJI patients. TRIAL REGISTRATION: This study was registered with Kantonale Ethikkommission Zürich, (BASEC-No. 2016-01048).