An interventional study of Posterior approach to infection site in Spondylodiscitis, Spinal Infection and Spondylitis, sponsored by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty. Completed at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty · Not applicable, Interventional, and Treatment
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.
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.
24 studies on the registry are indexed under Discitis; 5 are open to participants now.
Browse Discitis studies →Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty is the lead sponsor of 5 studies on the registry; none are open to participants now.
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- 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:
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.
Surgery time
Surgery time in minutes
Time frame: From enrollment to the end of surgery at 1 year
Hospital stays
Hospital stays in day
Time frame: From enrollment to the end of surgery at 1 year
Re-operation
Re-operation number
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On the 2nd day after discharge
Blood loss during surgery
Blood loss during surgery in ml
Time frame: During the intervention
Procalcitonin
Procalcitonin level in the blood in ng/mL
Time frame: 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)
Time frame: On the 2nd day after surgery
ESR
Erythrocyte sedimentation rate in mm/hr. Normal ESR ; \<20mm/hr.
Time frame: 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.
Time frame: 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.
Time frame: On the 2nd day after surgery
Plan to share: Yes
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Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty