Pyogenic Vertebral Osteomyelitis
Conditions
Keywords
Pyogenic Vertebral Osteomyelitis, Thoracic Spine Infection, Spinal Infection
Brief summary
This is a multicenter prospective randomized controlled trial comparing two posterior surgical approaches for thoracic pyogenic vertebral osteomyelitis (PVO). Eighty-nine patients from four hospitals were randomized 1:1 to either posterior transforaminal debridement and interbody fusion (PTDIF) with preservation of the posterior ligamentous complex, or posterolateral debridement and interbody fusion (PLDIF) which requires resection of the posterior ligamentous complex, proximal rib, and costotransverse joint. The primary outcomes included operative time, intraoperative blood loss, visual analog scale (VAS) pain scores, Oswestry Disability Index (ODI), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), ASIA neurological grade, kyphosis correction, and complications. All 89 patients achieved complete recovery. PTDIF resulted in significantly less blood loss and shorter operative time compared to PLDIF, with comparable clinical and radiological outcomes.
Detailed description
Pyogenic vertebral osteomyelitis (PVO) accounts for less than 4% of all bone infections but is associated with considerable morbidity. Surgical management of thoracic PVO remains controversial. This multicenter prospective randomized controlled trial was conducted at four hospitals between May 2021 and August 2023. Ninety-five patients with thoracic PVO were assessed for eligibility; six were excluded, and 89 patients were randomized using a random number table with sequentially numbered, opaque, sealed envelopes in a 1:1 ratio. Group A (n=44) underwent posterior transforaminal debridement and interbody fusion (PTDIF), which preserves the posterior ligamentous complex (PLC) and avoids costotransversectomy. Group B (n=45) underwent posterolateral debridement and interbody fusion (PLDIF), which involves resection of the PLC, proximal rib, and costotransverse joint. The study employed partial blinding: patients and data collectors were blinded to group allocation. Outcomes were assessed preoperatively and at regular postoperative intervals including VAS, ODI, ESR, CRP, ASIA grade, and radiographic kyphosis angle. Both groups achieved complete infection resolution, neurological improvement, and satisfactory kyphosis correction. PTDIF demonstrated significantly shorter operative time (155.3 ± 27.4 min vs. 198.5 ± 32.1 min, p\<0.05) and less intraoperative blood loss (472.5 ± 98.6 mL vs. 685.2 ± 124.3 mL, p\<0.05) compared to PLDIF.
Interventions
PROCEDUREPosterior Transforaminal Debridement and Interbody Fusion (PTDIF)
Posterior-only surgical approach using a transforaminal/transpedicular corridor that preserves the posterior ligamentous complex, contralateral lamina, and facet joints, while avoiding costotransversectomy. The procedure includes unilateral partial laminectomy or hemilaminectomy, complete unilateral facetectomy, corpectomy, discectomy, abscess evacuation, and titanium mesh cage reconstruction with pedicle screw instrumentation.
PROCEDUREPosterolateral Debridement and Interbody Fusion (PLDIF)
Posterolateral surgical approach involving resection of the spinous process, interspinous and supraspinous ligaments, 1-1.5 cm segment of the adjacent rib, and the costotransverse joint to create a wider lateral corridor. This is followed by unilateral hemilaminectomy and facetectomy, with subsequent debridement, fusion, and instrumentation identical to the PTDIF group.
Sponsors
Xiangya Hospital of Central South University
Changsha Central Hospital
The First People's Hospital of Changde City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Failure of conservative treatment for thoracic pyogenic vertebral osteomyelitis * Intractable back pain * Significant vertebral destruction leading to spinal instability and/or deformity * Neurological deterioration * Evident abscess formation * Diagnosis confirmed by histopathological examination, bacterial culture, and metagenomic next-generation sequencing (mNGS)
Exclusion criteria
* Patients without definitive microbiological or histopathological confirmation of PVO * Spinal tuberculosis (excluded via T-SPOT.TB assay and other diagnostic workup)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time (minutes) | Perioperative | Total operative time, defined as the duration from skin incision to completion of wound closure, measured in minutes. This includes all surgical steps including exposure, debridement, instrumentation, interbody fusion, and wound closure. Patient positioning, anesthesia induction, and surgical preparation time are excluded. Operative time is recorded by the circulating nurse and confirmed by the attending surgeon. |
| Intraoperative Blood Loss (mL) | Perioperative | Total intraoperative blood loss, defined as the sum of blood collected in the surgical suction canister (minus irrigation fluid volume) and the estimated blood absorbed by surgical sponges and drapes, measured in milliliters. Blood loss is recorded by the attending anesthesiologist at the conclusion of surgery from skin incision to wound closure. |
| Visual Analog Scale (VAS) Pain Score | Baseline and through study completion, an average of 38 months | Pain severity assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Patients are asked to rate their average back pain over the preceding week by marking a point on a 100-mm horizontal line anchored by "no pain" (0) at the left end and "worst imaginable pain" (10) at the right end. The distance from the left end to the patient's mark is measured in millimeters and converted to a 0-10 scale. Higher scores indicate greater pain severity. VAS is assessed by a blinded outcome assessor at each study visit. |
| Oswestry Disability Index (ODI) | Baseline and through study completion, an average of 38 months | Functional disability assessed using the Oswestry Disability Index (ODI) version 2.1, a self-administered questionnaire comprising 10 sections, each addressing a different domain of functional activity: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Each section is scored from 0 to 5, with higher values indicating greater disability. The total score is calculated as the sum of all section scores divided by the maximum possible score (50), expressed as a percentage (0-100%), where 0% represents no disability and 100% represents complete bed-bound disability. The ODI is completed by the patient at each study visit under the supervision of a blinded outcome assessor. |
| C-Reactive Protein (CRP) | Baseline and 3 months | Serum C-reactive protein (CRP) level, an acute-phase inflammatory marker, measured in mg/L to monitor infection resolution following surgery. Blood samples are collected via venipuncture and analyzed using immunoturbidimetric assay. CRP is assessed at baseline (preoperative) and 3 months postoperatively. Normalization is defined as CRP \< 10 mg/L. Higher values indicate greater inflammatory activity. Measurements are performed by the hospital central laboratory using standardized automated analyzers. |
| Erythrocyte Sedimentation Rate (ESR) | Baseline and 3 months | Erythrocyte sedimentation rate (ESR), a non-specific acute-phase inflammatory marker, measured in mm/hour to monitor infection resolution following surgery. Blood samples are collected via venipuncture into sodium citrate anticoagulant tubes and analyzed using the Westergren method. ESR is assessed at baseline (preoperative) and 3 months postoperatively. Normalization is defined as ESR \< 20 mm/h. Higher values indicate greater inflammatory activity. Measurements are performed by the hospital central laboratory using standardized automated analyzers. |
| ASIA Neurological Grade | Baseline and through study completion, an average of 38 months | Neurological status assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS), which classifies the severity of neurological deficit into five grades: A = Complete (no motor or sensory function preserved below the neurological level, including sacral segments S4-S5); B = Sensory Incomplete (sensory but not motor function preserved below the neurological level and including S4-S5); C = Motor Incomplete (motor function preserved below the neurological level, with more than half of key muscles below the level having a muscle grade less than 3); D = Motor Incomplete (motor function preserved below the neurological level, with at least half of key muscles below the level having a muscle grade of 3 or greater); E = Normal (motor and sensory function normal in all segments). The AIS is determined by a standardized neurological examination assessing motor strength of 10 key muscle groups bilaterally (graded 0-5) and sensory function of 28 dermatomes bilaterally (grad |
| Kyphosis Correction (degrees) | Baseline and through study completion, an average of 38 months | Regional kyphotic angle measured on lateral radiographs of the thoracolumbar spine using the Cobb method. The kyphotic angle is defined as the angle between the superior endplate of the vertebral body one level above the affected segment and the inferior endplate of the vertebral body one level below the affected segment. Kyphosis correction is calculated as the difference between the preoperative kyphotic angle and the kyphotic angle at final follow-up, expressed in degrees. A positive value indicates improvement (correction of kyphotic deformity), while a negative value indicates worsening of kyphosis. Measurements are performed on standard lateral radiographs using digital imaging software by a blinded radiologist. |
| Complications | From surgery through study completion, an average of 38 months | All postoperative complications assessed from the time of surgery through final follow-up. Complications include: pleural effusion, pneumothorax, pneumonia, and other pleuropulmonary complications; dural tear with cerebrospinal fluid leak; superficial and deep wound infection; hardware failure including screw loosening, rod breakage, or cage migration; infection recurrence requiring reoperation or prolonged antibiotic therapy; and any other surgery-related adverse events. Complications are recorded prospectively at each follow-up visit (4 weeks, 3, 6, 9, 12 months, and annually thereafter) and confirmed by clinical examination, laboratory tests, and imaging studies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Stay Duration (days) | From admission through discharge, an average of 14 days | Total length of hospital stay, defined as the number of days from the date of hospital admission to the date of hospital discharge, measured in days. The admission date is recorded as the day the patient was formally admitted to the hospital for surgical treatment. The discharge date is recorded as the day the patient was formally discharged by the attending physician following confirmation of clinical stability, including afebrile status, adequate wound healing, and independent mobilization. The day of admission is counted as Day 1. Both dates are obtained from the hospital electronic medical record system. |
Countries
China
Outcome results
None listed