- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07349602
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Chuvashskaya Respublika
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Cheboksary, Chuvashskaya Respublika, Russia, 428020
- Federal Center of Traumatology, Orthopedics and Arthroplasty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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.
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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
|
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Re-operation
Time Frame: From enrollment to the 1-year post-surgical treatment follow-up period
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Re-operation number
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From enrollment to the 1-year post-surgical treatment follow-up period
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VAS-pain after surgery
Time Frame: On the 2nd day after surgery
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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
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VAS-pain after discharge
Time Frame: On the 2nd day after discharge
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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
|
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Blood loss during surgery
Time Frame: During the intervention
|
Blood loss during surgery in ml
|
During the intervention
|
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Procalcitonin
Time Frame: On the 2nd day after surgery
|
Procalcitonin level in the blood in ng/mL
|
On the 2nd day after surgery
|
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C-reactive protein
Time Frame: On the 2nd day after surgery
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C-reactive protein in the blood in mg/L (Less than less than 3 mg/L consider be normal)
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On the 2nd day after surgery
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ESR
Time Frame: On the 2nd day after surgery
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Erythrocyte sedimentation rate in mm/hr.
Normal ESR ; <20mm/hr.
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On the 2nd day after surgery
|
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White blood cells
Time Frame: On the 2nd day after surgery
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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
|
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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.
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On the 2nd day after surgery
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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
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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