One Year Results of Managing Primary Spondylodiscitis

Overview

Primary spondylodiscitis is a severe infectious condition involving the spinal discs and adjacent vertebrae. It often causes significant back pain and requires careful management, typically involving long-term antibiotics and spinal braces, or surgery in more complex cases. The purpose of this observational study is to evaluate the one-year clinical and surgical outcomes of patients receiving standard-of-care treatment for primary spondylodiscitis at Assiut University Hospital. The study aims to enroll approximately 50 patients. Researchers will follow these participants prospectively for one year from the start of their treatment. During this time, patients will undergo regular clinical evaluations, laboratory blood tests (such as CRP and ESR to monitor infection and inflammation), and radiological imaging (like X-rays) at defined intervals to assess healing and spinal stability. The primary objective is to determine the overall cure rate at the one-year mark. Additionally, the study will measure secondary outcomes, including changes in pain levels, improvements in daily functional abilities, and the rate of any complications or necessary surgical interventions.

Primary spondylodiscitis represents a significant diagnostic and therapeutic challenge, with its incidence rising due to an aging population and increasing prevalence of comorbidities. This prospective exploratory clinical follow-up study aims to establish systematic data collection using REDCap to evaluate the clinical and surgical outcomes of patients managed for primary spondylodiscitis at Assiut University Hospital. Upon enrollment, all patients will undergo a comprehensive baseline assessment. This includes a structured medical history focusing on comorbidities (such as diabetes, malignancy, or immunocompromised states) and specific symptomatology. A thorough physical and neurological examination will be performed to assess spinal tenderness, range of motion, motor power, sensory levels, and sphincter function. Baseline laboratory investigations will include complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and aerobic/anaerobic blood cultures. Radiological assessment will proceed sequentially with plain radiographs, magnetic resonance imaging (MRI) with contrast, and computed tomography (CT) as needed. If blood cultures are negative or an epidural abscess is present, a percutaneous biopsy will be performed. Patients will be managed according to standard institutional protocols, which include: * Antibiotic Therapy: Intravenous empirical therapy (e.g., vancomycin combined with a broad-spectrum beta-lactam) will be initiated and later targeted based on culture results. Parenteral antibiotics will be administered for a minimum of 6 weeks. Transition to oral antibiotics will occur once clinical improvement and a ≥50% reduction in CRP are documented, for a total minimum treatment duration of 8 to 12 weeks. * Spinal Immobilization: Conservatively managed patients will be fitted with a spinal orthosis to minimize mechanical stress and prevent deformity, maintained for a minimum of 10 weeks. * Surgical Intervention: Surgery will be indicated for patients presenting with progressive neurological deficits, spinal instability, large/inaccessible abscesses, or failure to respond to at least 6 weeks of adequate antimicrobial therapy. Intraoperative tissue biopsies will be sent for microbiological and histopathological examination. Patients will be followed prospectively for one year from the initiation of treatment. * Clinical Monitoring: Pain and functional outcomes will be evaluated using the Visual Analogue Scale (VAS), AO Spine PROST, EQ-5D, SITE Score, and SISS Score at predetermined intervals: baseline, 6 weeks, and at 3, 6, 9 (for specific scores), and 12 months. * Laboratory Monitoring: CRP and ESR will be measured at baseline, at 6 weeks post-treatment, and then every 2 months until normalization. A target CRP of \<5 mg/L on two consecutive measurements serves as the biochemical cure benchmark. * Radiological Monitoring: Plain X-rays will be obtained at 3, 6, and 12 months to evaluate spinal alignment, stability, and bony fusion. Advanced imaging (CT or MRI) will only be repeated in cases of clinical deterioration, worsening pain, or new neurological deficits to detect complications or recurrence.