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

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

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

Interventional

Enrollment (Actual)

47

Phase

  • 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

    • 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

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
Intervention / Treatment
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.
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

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.

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)

January 1, 2019

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

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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