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BACKGROUND: Patients surgically treated for lumbar spinal stenosis or cervical radiculopathy report improvement in approximately two out of three cases. Advancements in Machine Learning and the utility of large datasets have enabled the development of prognostic prediction models within spine surgery. This trial investigates if the use of the postoperative outcome prediction model, the Dialogue Support, can alter patient-reported outcome and satisfaction compared to current practice. METHODS: This is a prospective, multicenter clinical trial. Patients referred to a spine clinic with cervical radiculopathy or lumbar spinal stenosis will be screened for eligibility. Participants will be assessed at baseline upon recruitment and at 12 months follow-up. The Dialogue Support will be used on all participants, and they will thereafter be placed into either a surgical or a non-surgical treatment arm, depending on the decision made between patient and surgeon. The surgical treatment group will be studied separately based on diagnosis of either cervical radiculopathy or lumbar spinal stenosis. Both the surgical and the non-surgical group will be compared to a retrospective matched control group retrieved from the Swespine register, on which the Dialogue Support has not been used. The primary outcome measure is global assessment regarding leg/arm pain in the surgical treatment group. Secondary outcome measures include patient satisfaction, Oswestry Disability Index (ODI), EQ-5D, and Numeric Rating Scales (NRS) for pain. In the non-surgical treatment group primary outcome measures are EQ-5D and mortality, as part of a selection bias analysis. DISCUSSION: The findings of this study may provide evidence on whether the use of an advanced digital decision tool can alter patient-reported outcomes after surgery. TRIAL REGISTRATION: The trial was retrospectively registered at ClinicalTrials.gov on April 17th, 2023, NCT05817747. PROTOCOL VERSION: 1. TRIAL DESIGN: Clinical multicenter trial.

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A peri-prosthetic joint infection is a feared complication after mega-prosthesis reconstruction of large bone defects. The current study investigates how patients operated with a mega-prosthesis due to sarcoma, metastasis, or trauma, are affected by a deep infection focusing on re-operations, risk for persistent infection, arthrodesis, or subsequent amputation. Time to infection, causative bacterial strains, mode of treatment and length of hospital stay are also reported. A total of 114 patients with 116 prostheses were evaluated, a median of 7.6 years (range 3.8-13.7) after surgery, of which 35 (30%) were re-operated due to a peri-prosthetic infection. Of the infected patients, the prosthesis was still in place in 51%, 37% were amputated, and 9% had an arthrodesis. The infection was persistent in 26% of the infected patients at follow-up. The mean total length of hospital stay was 68 (median 60) days and the mean number of reoperations was 8.9 (median 6.0). The mean length of antibiotic treatment was 340 days (median 183). Coagulase-negative staphylococci and Staphylococcus aureus were the most frequent bacterial agents isolated in deep cultures. No MRSA- or ESBL-producing Enterobacterales were found but vancomycin-resistant Enterococcus faecium was isolated in one patient. In summary, there is a high risk for peri-prosthetic infection in mega-prostheses, resulting in persistent infection or amputation relatively often.

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BACKGROUND: Cervical spondylotic myelopathy (CSM) is the predominant cause of spinal cord dysfunction in the elderly. The patients are often frail and susceptible to complications. Posterior surgical techniques involving non-fusion are complicated by postlaminectomy kyphosis and instrumented fusion techniques by distal junction kyphosis, pseudarthrosis, or implant failure. The optimal surgical approach is still a matter of controversy. Since anterior and posterior fusion techniques have been compared without presenting any superiority, the objective of this study is to compare stand-alone laminectomy with laminectomy and fusion to determine which treatment has the lowest frequency of reoperations. METHODS: This is a multicenter randomized, controlled, parallel-group non-inferiority trial. A total of 300 adult patients are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason at 5 years of follow-up. Sample size and power calculation were performed by estimating the reoperation rate after laminectomy to 3.5% and after laminectomy with fusion to 7.4% based on the data from the Swedish spine registry (Swespine) on patients with CSM. Secondary outcomes are the patient-derived Japanese Orthopaedic Association (P-mJOA) score, Neck Disability Index (NDI), European Quality of Life Five Dimensions (EQ-5D), Numeric Rating Scale (NRS) for neck and arm pain, Hospital Anxiety and Depression Scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA), and death. Clinical and radiological follow-up is performed at 3, 12, 24, and 60 months after surgery. The main inclusion criterium is 1-4 levels of CSM in the subaxial spine, C3-C7. The REDcap software will be used for safe data management. Data will be analyzed according to the modified intention to treat (mITT) population, defined as randomized patients who are still alive without having emigrated or left the study after 2 and 5 years. DISCUSSION: This will be the first randomized controlled trial comparing two of the most common surgical treatments for CSM: the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the myelopathy randomized controlled (MyRanC) study will provide surgical treatment recommendations for CSM. This may result in improvements in surgical treatment and clinical practice regarding CSM. TRIAL REGISTRATION: ClinicalTrials.gov NCT04936074 . Registered on 23 June 2021.

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AIM: The one-year prevalence of diagnosed nonspecific back pain in Sweden is not known. Thus, this observational register-based study aimed to evaluate this prevalence by using data from the Region Västra Götaland, inhabiting 1.7 million people. METHODS: Data from 2014 to 2018 were extracted from the VEGA database register. This register holds all health data from the publicly funded health care establishments in Region Västra Götaland. Aggregated data are presented as the one-year prevalence of unique individuals diagnosed with nonspecific back pain (i.e., the ICD-10 code M54). Stratification by health care level, gender, age, and M54 sub-diagnoses were made. FINDINGS: Between 2014 and 2018, the annual prevalence of diagnosed nonspecific back pain in public primary health care increased from 4.8% to 6.0% (26% increase, P < 0.001, CI 25-27%). In 2018, the one-year prevalence was 7.2% among women and 4.8% among men (50% difference, P = 0.001, CI 49-52%). The one-year prevalence increased by age, and the highest figure (11%) was seen in the age group of 80-84. Low back pain, M54.5, was the most common sub-diagnosis. The one-year prevalence was significantly higher (P < 0.001) among women in all the M54 sub-diagnoses. CONCLUSION: The one-year prevalence of diagnosed nonspecific back pain was 6% in public primary health care in 2018 and has increased since 2014. Women were diagnosed considerably more frequently than men. Publicly funded rehabilitation efforts, as well as actions focusing on the prevention of back pain, is probably money well spent.

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