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NCT Number: NCT07349602

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

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.

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Key information

Conditions

Spondylodiscitis Bone Diseases Bone Diseases, Infectious Discitis Infections Musculoskeletal Diseases Osteomyelitis Pyogenic Infections Spinal Diseases Spinal Infection Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal Center of Traumatology, Orthopedics and Arthroplasty

Cheboksary, Chuvashskaya Respublika, 428020, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Surgery time

    Time frame: From enrollment to the end of surgery at 1 year

    Surgery time in minutes

  2. Hospital stays

    Time frame: From enrollment to the end of surgery at 1 year

    Hospital stays in day

  3. Re-operation

    Time frame: From enrollment to the 1-year post-surgical treatment follow-up period

    Re-operation number

  4. 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.

  5. 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.

  6. 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.

  7. Blood loss during surgery

    Time frame: During the intervention

    Blood loss during surgery in ml

  8. Procalcitonin

    Time frame: On the 2nd day after surgery

    Procalcitonin level in the blood in ng/mL

  9. 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)

  10. ESR

    Time frame: On the 2nd day after surgery

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

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty

Other

Registry information

Official study title

The Use of Posterior Approach for Surgical Treatment of Nonspecific Spondylodiscitis.

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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