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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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07349602
Enrollment
47
Registered
2026-01-20
Start date
2019-01-01
Completion date
2023-01-01
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

pyogenic, Spondylodiscitis, posterior approach, microbiological profiles

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.

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.

Interventions

PROCEDUREPosterior 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Surgery timeFrom enrollment to the end of surgery at 1 yearSurgery time in minutes
Hospital staysFrom enrollment to the end of surgery at 1 yearHospital stays in day
Re-operationFrom enrollment to the 1-year post-surgical treatment follow-up periodRe-operation number
Health Questionnaire EuroQol 5 Dimension five levels (EQ-5D-5L)From enrollment to the end of surgery at 1 yearThe 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 surgeryOn the 2nd day after surgeryVAS-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 dischargeOn the 2nd day after dischargeVAS-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 surgeryDuring the interventionBlood loss during surgery in ml
ProcalcitoninOn the 2nd day after surgeryProcalcitonin level in the blood in ng/mL
C-reactive proteinOn the 2nd day after surgeryC-reactive protein in the blood in mg/L (Less than less than 3 mg/L consider be normal)
ESROn the 2nd day after surgeryErythrocyte sedimentation rate in mm/hr. Normal ESR ; \<20mm/hr.
White blood cellsOn the 2nd day after surgeryWhite blood cells. The normal number of WBCs in the blood is 4.5 to 11.0 × 109/L.
HemoglobinOn the 2nd day after surgeryHemoglobin 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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026