Pyogenic Vertebral OsteomyelitisPTDIF-PVONCT07817927
Posterior Transforaminal Debridement and Fusion Without Costotransversectomy for Thoracic Pyogenic Vertebral Osteomyelitis
A study testing Posterior Transforaminal Debridement and Interbody Fusion (PTDIF) and Posterolateral Debridement and Interbody Fusion (PLDIF) in people with Pyogenic Vertebral Osteomyelitis, run by Xiangya Hospital of Central South University at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyogenic Vertebral Osteomyelitis
- What is being tested?
- Posterior Transforaminal Debridement and Interbody Fusion (PTDIF) and Posterolateral Debridement and Interbody Fusion (PLDIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 4 sitesChina
- Study dates
- 1 May 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients without definitive microbiological or histopathological confirmation of PVO
- Spinal tuberculosis (excluded via T-SPOT.TB assay and other diagnostic workup)
Trial locations and contacts
4 sites in 1 country.
China4 sites
Changde First People's Hospital
Changde, Hunan, 410008
Changsha Central Hospital
Changsha, Hunan, 410008
Xiangya Boai Rehabilitation Hospital
Changsha, Hunan, 410008
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
About this study
Official title: Posterior Transforaminal Debridement and Fusion Without Costotransversectomy for Thoracic Pyogenic Vertebral Osteomyelitis: A Randomized Controlled Trial Emphasizing Posterior Ligamentous Complex Preservation
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.
Read the 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.
- Conditions
- Pyogenic Vertebral Osteomyelitis
- Being tested
- Posterior Transforaminal Debridement and Interbody Fusion (PTDIF), Posterolateral Debridement and Interbody Fusion (PLDIF)
- Keywords
- Pyogenic Vertebral Osteomyelitis, Thoracic Spine Infection, Spinal Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Transforaminal Debridement and Interbody Fusion (PTDIF)Procedure or surgery
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.
Posterolateral Debridement and Interbody Fusion (PLDIF)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - PTDIF Group | Experimental | 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. Receives: Procedure: Posterior Transforaminal Debridement and Interbody Fusion (PTDIF) |
| Active Comparator - PLDIF Group | Active comparator | 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. Receives: Procedure: Posterolateral Debridement and Interbody Fusion (PLDIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative
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.
Measured: Perioperative
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.
Measured: Baseline and through study completion, an average of 38 months
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.
Measured: Baseline and through study completion, an average of 38 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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
Measured: Baseline and through study completion, an average of 38 months
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.
Measured: Baseline and through study completion, an average of 38 months
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.
Measured: 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.
Measured: From admission through discharge, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 May 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyogenic Vertebral OsteomyelitisStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Changsha Central Hospital, The First People's Hospital of Changde City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817927
- Sponsor's protocol ID
- XYH-PVO-2021-001
- Acronym
- PTDIF-PVO
- Status last verified
- May 2021
- First submitted
- 19 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Transforaminal Debridement and Fusion Without Costotransversectomy for Thoracic Pyogenic Vertebral Osteomyelitis: A Randomized Controlled Trial Emphasizing Posterior Ligamentous Complex Preservation
- ClinicalTrials.gov ID
- NCT07817927
- Acronym / sponsor ID
- PTDIF-PVO / XYH-PVO-2021-001
- Conditions
- Pyogenic Vertebral Osteomyelitis
- Keywords
- Pyogenic Vertebral Osteomyelitis, Thoracic Spine Infection, Spinal Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Changsha Central Hospital, The First People's Hospital of Changde City
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - PTDIF Group | Experimental | Procedure: Posterior 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. |
| Active Comparator - PLDIF Group | Active comparator | Procedure: Posterolateral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients without definitive microbiological or histopathological confirmation of PVO
- Spinal tuberculosis (excluded via T-SPOT.TB assay and other diagnostic workup)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior 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. | Procedure or surgery | Experimental - PTDIF Group |
| Posterolateral 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. | Procedure or surgery | Active Comparator - PLDIF Group |
Primary outcome
Operative Time (minutes)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
1 secondary outcome
Hospital Stay Duration (days)
Time frame: From admission through discharge, an average of 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Transforaminal Debridement and Interbody Fusion (PTDIF) and Posterolateral Debridement and Interbody Fusion (PLDIF) in people with Pyogenic Vertebral Osteomyelitis, run by Xiangya Hospital of Central South University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (minutes) (time frame: Perioperative). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.