SpondylodiscitisNCT07349602
Evaluation of Outcomes of Surgical Treatment for Nonspecific Infectious Spondylodiscitis Via Posterior Approach in One Center.
A study testing Posterior approach to infection site in people with Spondylodiscitis and Spinal Infection, run by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty at 1 site in Russia.
Trial summary
Non-specific spondylodiscitis is a bacterial infection of the spine that in some cases requires surgical treatment. The basis of surgical treatment is the removal of affected tissues. In this case, the supportive function of the affected area is lost, which also requires stable fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylodiscitis, Spinal Infection, Spondylitis
- What is being tested?
- Posterior approach to infection site
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2019to 1 Jan 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
- a deep infection affecting intervertebral discs and adjacent vertebral bodies in thoracolumbar spine region which were classified as B.3.1-2 and C2-C4 according to the Pola classification
Who cannot join
- cervical spine region infection
- unwilling to participate in the study,
- patients with SD of a specific etiology
- patients who received only conservative treatment,
- patients with intradural infections.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Center of Traumatology, Orthopedics and Arthroplasty
Cheboksary, Chuvashskaya Respublika, 428020
About this study
Official title: The Use of Posterior Approach for Surgical Treatment of Nonspecific Spondylodiscitis.
Non-specific spondylodiscitis is a bacterial infection of the spine that in some cases requires surgical treatment. The basis of surgical treatment is the removal of affected tissues. In this case, the supportive function of the affected area is lost, which also requires stable fixation. Access to the affected part of the spine can be achieved through both anterior and posterior approaches. There is no reliable data yet confirming the advantages of each approach. Our study demonstrated successful surgical treatment of infection foci using posterior approach, no neurological or other complications were occurred. Older patients shown differences in hemoglobin levels, postoperative pain scores, the number of affected vertebrae, types of bacteria and recurrent rate.
Read the detailed description
This retrospective study was conducted on 38 patients with spondylodiscitis treated using a posterior approach. Clinical data were evaluated in four age groups: under 39 years, 40-49 years, and 50-59 years and over 60.
- Conditions
- Spondylodiscitis, Spinal Infection, Spondylitis, Discitis, Osteomyelitis, Pyogenic Infections
- Being tested
- Posterior approach to infection site
- Keywords
- pyogenic, Spondylodiscitis, posterior approach, microbiological profiles
- Medical subject headings
- Discitis, Spondylitis, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior approach to infection siteProcedure or surgery
For the posterior approach, an incision through the skin, subcutaneous fat, and aponeurosis was made with the patient in the prone position, projecting through the spinous processes of the vertebrae above the infection site and one adjacent vertebra. In all cases, a thorough exploration and debridement of the infection site was performed. Bone biopsies were taken from suspected infection sites in all patients for culture.
| Study group | Role | What they receive |
|---|---|---|
| Posterial approach | Experimental | All patients with spondilodiscitis admitted to surgical treatment in one center. During the operation, a posterior approach was used to access the source of infection. The incision of the skin, subcutaneous fat, and aponeurosis was made with the patient in the prone position, projecting through the spinous processes of the vertebrae above the infection site and one adjacent vertebra. Receives: Procedure: Posterior approach to infection site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery time
Surgery time in minutes
Measured: From enrollment to the end of surgery at 1 year
Hospital stays
Hospital stays in day
Measured: From enrollment to the end of surgery at 1 year
Re-operation
Re-operation number
Measured: From enrollment to the 1-year post-surgical treatment follow-up period
Health Questionnaire EuroQol 5 Dimension five levels (EQ-5D-5L)
The EQ-5D-5L descriptive system uses five dimensions and five levels of severity in each dimension. TThe five dimensions include mobility, self-care, activities of daily living, pain and discomfort, and anxiety and depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems' and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression).
Their responses are coded as a number (1, 2, 3, 4 or 5) that corresponds to the respective level of severity: 1 indicates no problems, 2-4 some problems and 3 extreme problems. In this way, a person's health state profile can be defined by a 5-digit number, ranging from 11111 (having no problems in any of the dimensions) to 55555 (having extreme problems in all the dimensions).
The assigning of a value to an EQ-5D state is based on the time trade-off (TTO) approach.
Measured: From enrollment to the end of surgery at 1 year
VAS-pain after surgery
VAS-pain on the 2nd day after surgery. Visual analog scale (0-10 VAS) and it was categorized using the following terms : no pain (0), mild (1-3), moderate (4-6), severe (7-9), or worse pain.
Measured: On the 2nd day after surgery
VAS-pain after discharge
VAS-pain on the 2nd day after discharge. Visual analog scale (0-10 VAS) and it was categorized using the following terms : no pain (0), mild (1-3), moderate (4-6), severe (7-9), or worse pain.
Measured: On the 2nd day after discharge
Blood loss during surgery
Blood loss during surgery in ml
Measured: During the intervention
Procalcitonin
Procalcitonin level in the blood in ng/mL
Measured: On the 2nd day after surgery
C-reactive protein
C-reactive protein in the blood in mg/L (Less than less than 3 mg/L consider be normal)
Measured: On the 2nd day after surgery
ESR
Erythrocyte sedimentation rate in mm/hr. Normal ESR ; <20mm/hr.
Measured: On the 2nd day after surgery
White blood cells
White blood cells. The normal number of WBCs in the blood is 4.5 to 11.0 × 109/L.
Measured: On the 2nd day after surgery
Hemoglobin
Hemoglobin level in grams per deciliter. Normal hemoglobin for men ranges from 13.5 to 17.5 g/dL. Normal range for women is 12.0 to 15.5 g/dL.
Measured: On the 2nd day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2019
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylodiscitisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with a deep infection affecting intervertebral discs and neighboring vertebral bodies in the thoracolumbar spine area, which were categorized as B.3.1-2 and C2-C4 according to the Pola classification.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349602
- Sponsor's protocol ID
- 2024-2
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Posterior Approach for Surgical Treatment of Nonspecific Spondylodiscitis.
- ClinicalTrials.gov ID
- NCT07349602
- Acronym / sponsor ID
- 2024-2
- Conditions
- Spondylodiscitis, Spinal Infection, Spondylitis, Discitis, Osteomyelitis, Pyogenic Infections
- Keywords
- pyogenic, Spondylodiscitis, posterior approach, microbiological profiles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and ArthroplastyUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 20 Jan 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.
Non-specific spondylodiscitis is a bacterial infection of the spine that in some cases requires surgical treatment. The basis of surgical treatment is the removal of affected tissues. In this case, the supportive function of the affected area is lost, which also requires stable fixation. Access to the affected part of the spine can be achieved through both anterior and posterior approaches. There is no reliable data yet confirming the advantages of each approach. Our study demonstrated successful surgical treatment of infection foci using posterior approach, no neurological or other complications were occurred. Older patients shown differences in hemoglobin levels, postoperative pain scores, the number of affected vertebrae, types of bacteria and recurrent rate.
Detailed description
This retrospective study was conducted on 38 patients with spondylodiscitis treated using a posterior approach. Clinical data were evaluated in four age groups: under 39 years, 40-49 years, and 50-59 years and over 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with a deep infection affecting intervertebral discs and neighboring vertebral bodies in the thoracolumbar spine area, which were categorized as B.3.1-2 and C2-C4 according to the Pola classification.
| Arm | Type | Receives |
|---|---|---|
| Posterial approach | Experimental | Procedure: Posterior approach to infection siteAll patients with spondilodiscitis admitted to surgical treatment in one center. During the operation, a posterior approach was used to access the source of infection. The incision of the skin, subcutaneous fat, and aponeurosis was made with the patient in the prone position, projecting through the spinous processes of the vertebrae above the infection site and one adjacent vertebra. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a deep infection affecting intervertebral discs and adjacent vertebral bodies in thoracolumbar spine region which were classified as B.3.1-2 and C2-C4 according to the Pola classification
Key exclusion criteria (5 listed)
- cervical spine region infection
- unwilling to participate in the study,
- patients with SD of a specific etiology
- patients who received only conservative treatment,
- patients with intradural infections.
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 approach to infection siteFor the posterior approach, an incision through the skin, subcutaneous fat, and aponeurosis was made with the patient in the prone position, projecting through the spinous processes of the vertebrae above the infection site and one adjacent vertebra. In all cases, a thorough exploration and debridement of the infection site was performed. Bone biopsies were taken from suspected infection sites in all patients for culture. | Procedure or surgery | Posterial approach |
Primary outcome
Surgery time
Time frame: From enrollment to the end of surgery at 1 year
Surgery time in minutes
Hospital stays
Time frame: From enrollment to the end of surgery at 1 year
Hospital stays in day
Re-operation
Time frame: From enrollment to the 1-year post-surgical treatment follow-up period
Re-operation number
Health Questionnaire EuroQol 5 Dimension five levels (EQ-5D-5L)
Time frame: From enrollment to the end of surgery at 1 year
The EQ-5D-5L descriptive system uses five dimensions and five levels of severity in each dimension. TThe five dimensions include mobility, self-care, activities of daily living, pain and discomfort, and anxiety and depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems' and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). Their responses are coded as a number (1, 2, 3, 4 or 5) that corresponds to the respective level of severity: 1 indicates no problems, 2-4 some problems and 3 extreme problems. In this way, a person's health state profile can be defined by a 5-digit number, ranging from 11111 (having no problems in any of the dimensions) to 55555 (having extreme problems in all the dimensions). The assigning of a value to an EQ-5D state is based on the time trade-off (TTO) approach.
VAS-pain after surgery
Time frame: On the 2nd day after surgery
VAS-pain on the 2nd day after surgery. Visual analog scale (0-10 VAS) and it was categorized using the following terms : no pain (0), mild (1-3), moderate (4-6), severe (7-9), or worse pain.
VAS-pain after discharge
Time frame: On the 2nd day after discharge
VAS-pain on the 2nd day after discharge. Visual analog scale (0-10 VAS) and it was categorized using the following terms : no pain (0), mild (1-3), moderate (4-6), severe (7-9), or worse pain.
Blood loss during surgery
Time frame: During the intervention
Blood loss during surgery in ml
Procalcitonin
Time frame: On the 2nd day after surgery
Procalcitonin level in the blood in ng/mL
C-reactive protein
Time frame: On the 2nd day after surgery
C-reactive protein in the blood in mg/L (Less than less than 3 mg/L consider be normal)
ESR
Time frame: On the 2nd day after surgery
Erythrocyte sedimentation rate in mm/hr. Normal ESR ; <20mm/hr.
White blood cells
Time frame: On the 2nd day after surgery
White blood cells. The normal number of WBCs in the blood is 4.5 to 11.0 × 109/L.
Hemoglobin
Time frame: On the 2nd day after surgery
Hemoglobin level in grams per deciliter. Normal hemoglobin for men ranges from 13.5 to 17.5 g/dL. Normal range for women is 12.0 to 15.5 g/dL.
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 22 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior approach to infection site in people with Spondylodiscitis and Spinal Infection, run by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty at 1 site in Russia.
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 1 inclusion and 5 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Surgery time (time frame: From enrollment to the end of surgery at 1 year). The study lists 12 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 22 Jan 2026.