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

NCT07349602 | Completed DMC

• 1 other identifier: 2024-2
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteomyelitis; Pyogenic Infections; Spondylodiscitis; Spinal Infection; Spondylitis; Discitis

Keywords

pyogenic; Spondylodiscitis; posterior approach; microbiological profiles

Outcome Measures

Primary Outcomes (12)

• Surgery time

  Surgery time in minutes

  From enrollment to the end of surgery at 1 year

• Hospital stays

  Hospital stays in day

  From enrollment to the end of surgery at 1 year

• Re-operation

  Re-operation number

  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.

  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.

  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.

  On the 2nd day after discharge

• Blood loss during surgery

  Blood loss during surgery in ml

  During the intervention

• Procalcitonin

  Procalcitonin level in the blood in ng/mL

  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)

  On the 2nd day after surgery

• ESR

  Erythrocyte sedimentation rate in mm/hr. Normal ESR ; \<20mm/hr.

  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.

  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.

  On the 2nd day after surgery

Study Arms (1)

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.

Procedure: Posterior approach to infection site

Interventions

Posterior approach to infection site PROCEDURE

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.

Posterial approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty: lead

Study Sites (1)

Federal Center of Traumatology, Orthopedics and Arthroplasty

Cheboksary, Chuvashskaya Respublika, 428020, Russia

Location

MeSH Terms

Conditions

Discitis; Spondylitis; Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients were informed about the upcoming surgery and its outcome - healing from infection. However, due to a lack of specialized medical training, they were unable to evaluate the use of the posterior approach. Outcome assessments were conducted without mentioning the use of the operative approach.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)