Evaluation of Outcomes of Surgical Treatment for Nonspecific Infectious Spondylodiscitis Via Posterior Approach in One Center.

January 21, 2026 updated by: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
    • Chuvashskaya Respublika
      • Cheboksary, Chuvashskaya Respublika, Russia, 428020
        • Federal Center of Traumatology, Orthopedics and Arthroplasty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Posterial approach
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.
Procedure: Posterior approach to infection site
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgery time
Time Frame: From enrollment to the end of surgery at 1 year
Surgery time in minutes
From enrollment to the end of surgery at 1 year
Hospital stays
Time Frame: From enrollment to the end of surgery at 1 year
Hospital stays in day
From enrollment to the end of surgery at 1 year
Re-operation
Time Frame: From enrollment to the 1-year post-surgical treatment follow-up period
Re-operation number
From enrollment to the 1-year post-surgical treatment follow-up period
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.
On the 2nd day after surgery
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.
On the 2nd day after discharge
Blood loss during surgery
Time Frame: During the intervention
Blood loss during surgery in ml
During the intervention
Procalcitonin
Time Frame: On the 2nd day after surgery
Procalcitonin level in the blood in ng/mL
On the 2nd day after surgery
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)
On the 2nd day after surgery
ESR
Time Frame: On the 2nd day after surgery
Erythrocyte sedimentation rate in mm/hr. Normal ESR ; <20mm/hr.
On the 2nd day after surgery
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.
On the 2nd day after surgery
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.
On the 2nd day after surgery
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.
From enrollment to the end of surgery at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-2

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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