Posterior Transforaminal Debridement and Fusion Without Costotransversectomy for Thoracic Pyogenic Vertebral Osteomyelitis

Browse trials for

• Osteomyelitis 105

Keywords

• Pyogenic Vertebral Osteomyelitis
• Thoracic Spine Infection
• Spinal Infection

Osteomyelitis

105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.

This study's enrollment of 89 is above the median of 74 across 60 interventional studies indexed under Osteomyelitis.

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.

Study arms

• Experimental
  Experimental - PTDIF Group

  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.

  Procedure: Posterior Transforaminal Debridement and Interbody Fusion (PTDIF)

• Active comparator
  Active Comparator - PLDIF Group

  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.

  Procedure: Posterolateral Debridement and Interbody Fusion (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.

Primary outcomes

1. Operative Time (minutes)

   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.

   Time frame: Perioperative

2. Intraoperative Blood Loss (mL)

   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.

   Time frame: Perioperative

3. Visual Analog Scale (VAS) Pain Score

   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.

   Time frame: Baseline and through study completion, an average of 38 months

4. Oswestry Disability Index (ODI)

   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.

   Time frame: Baseline and through study completion, an average of 38 months

5. C-Reactive Protein (CRP)

   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.

   Time frame: Baseline and 3 months

6. Erythrocyte Sedimentation Rate (ESR)

   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.

   Time frame: Baseline and 3 months

7. ASIA Neurological Grade

   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

   Time frame: Baseline and through study completion, an average of 38 months

8. Kyphosis Correction (degrees)

   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.

   Time frame: Baseline and through study completion, an average of 38 months

9. Complications

   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.

   Time frame: From surgery through study completion, an average of 38 months

Secondary outcomes

1. Hospital Stay Duration (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.

   Time frame: From admission through discharge, an average of 14 days

Individual participant data

Plan to share: Yes — De-identified individual participant data that underlie the results of this study, along with the study protocol and statistical analysis plan, will be made available upon reasonable request to the corresponding author.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data will be available beginning 6 months after publication for a period of 5 years.

Access criteria: Individual participant data will be available upon reasonable request to the corresponding author, subject to approval by the Institutional Review Board of Xiangya Hospital of Central South University to ensure patient privacy protection.