One Year Results of Managing Primary Spondylodiscitis

One Year Results of Managing Primary Spondylodiscitis in a Tertiary Care Center

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Infection; Primary Spondylodiscitis; Pyogenic Spondylodiscitis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises patients of any age or sex presenting to the Orthopedic and Trauma Surgery Department (encompassing both inpatient wards and outpatient clinics) at Assiut University Hospital with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis.

Description

Inclusion Criteria:

• All patients presenting to Assiut University Hospital and its affiliated outpatient clinics with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis, regardless of age or sex.

Exclusion Criteria:

• Patients with postoperative or iatrogenic spinal infections (secondary spondylodiscitis following spinal surgery or instrumentation).
• Non-pyogenic spondylodiscitis.
• Patients with incomplete medical records or insufficient follow-up data.
• Patients who decline to provide informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Primary Pyogenic Spondylodiscitis Cohort; A single cohort consisting of all eligible patients presenting with clinical symptoms and/or radiological findings suggestive of primary pyogenic (bacterial) spondylodiscitis. Participants will be managed according to the current standard of care treatment protocols, which involve either conservative management or surgical intervention. Conservative management includes prolonged empirical or targeted antibiotic therapy for a minimum of 8-12 weeks combined with spinal immobilization using an orthosis for at least 10 weeks . Surgical intervention is indicated for patients with progressive neurological deficits, spinal instability, large abscesses, or failure to respond to conservative medical management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Achieving Definitive Cure	This outcome measures the overall cure rate among participants. A definitive cure is successfully achieved if the patient survives without documented disease recurrence, does not require additional unplanned antibiotic courses or reoperation, and shows radiological confirmation of infection eradication with restored or maintained spinal stability.	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Orthopedic Surgery; Conservative Management; Surgical Intervention; Tertiary Care; Primary Spondylodiscitis; Pyogenic Spondylodiscitis; Spinal Infection; Epidural Abscess
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Suppuration; Central Nervous System Infections; Abscess; Perimeningeal Infections; Epidural Abscess
• Other Study ID Numbers: Managing of Spondylodiscitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No