Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 1:46 PM
Study NCT ID:
NCT07349602
Status:
COMPLETED
Last Update Posted:
2026-01-22
First Post:
2025-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Outcomes of Surgical Treatment for Nonspecific Infectious Spondylodiscitis Via Posterior Approach in One Center.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015299', 'term': 'Discitis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D010019', 'term': 'Osteomyelitis'}], 'ancestors': [{'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013122', 'term': 'Spinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgery time', 'timeFrame': 'From enrollment to the end of surgery at 1 year', 'description': 'Surgery time in minutes'}, {'measure': 'Hospital stays', 'timeFrame': 'From enrollment to the end of surgery at 1 year', 'description': 'Hospital stays in day'}, {'measure': 'Re-operation', 'timeFrame': 'From enrollment to the 1-year post-surgical treatment follow-up period', 'description': 'Re-operation number'}, {'measure': 'Health Questionnaire EuroQol 5 Dimension five levels (EQ-5D-5L)', 'timeFrame': 'From enrollment to the end of surgery at 1 year', 'description': "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).\n\nTheir 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).\n\nThe assigning of a value to an EQ-5D state is based on the time trade-off (TTO) approach."}, {'measure': 'VAS-pain after surgery', 'timeFrame': 'On the 2nd day after surgery', 'description': '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.'}, {'measure': 'VAS-pain after discharge', 'timeFrame': 'On the 2nd day after discharge', 'description': '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.'}, {'measure': 'Blood loss during surgery', 'timeFrame': 'During the intervention', 'description': 'Blood loss during surgery in ml'}, {'measure': 'Procalcitonin', 'timeFrame': 'On the 2nd day after surgery', 'description': 'Procalcitonin level in the blood in ng/mL'}, {'measure': 'C-reactive protein', 'timeFrame': 'On the 2nd day after surgery', 'description': 'C-reactive protein in the blood in mg/L (Less than less than 3 mg/L consider be normal)'}, {'measure': 'ESR', 'timeFrame': 'On the 2nd day after surgery', 'description': 'Erythrocyte sedimentation rate in mm/hr. Normal ESR ; \\<20mm/hr.'}, {'measure': 'White blood cells', 'timeFrame': 'On the 2nd day after surgery', 'description': 'White blood cells. The normal number of WBCs in the blood is 4.5 to 11.0 × 109/L.'}, {'measure': 'Hemoglobin', 'timeFrame': 'On the 2nd day after surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pyogenic', 'Spondylodiscitis', 'posterior approach', 'microbiological profiles'], 'conditions': ['Spondylodiscitis', 'Spinal Infection', 'Spondylitis', 'Discitis', 'Osteomyelitis', 'Pyogenic Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 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\n\nExclusion Criteria:\n\n* cervical spine region infection\n* unwilling to participate in the study,\n* patients with SD of a specific etiology\n* patients who received only conservative treatment,\n* patients with intradural infections.'}, 'identificationModule': {'nctId': 'NCT07349602', 'briefTitle': 'Evaluation of Outcomes of Surgical Treatment for Nonspecific Infectious Spondylodiscitis Via Posterior Approach in One Center.', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty'}, 'officialTitle': 'The Use of Posterior Approach for Surgical Treatment of Nonspecific Spondylodiscitis.', 'orgStudyIdInfo': {'id': '2024-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Posterial approach', 'description': '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.', 'interventionNames': ['Procedure: Posterior approach to infection site']}], 'interventions': [{'name': 'Posterior approach to infection site', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Posterial approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '428020', 'city': 'Cheboksary', 'state': 'Chuvashskaya Respublika', 'country': 'Russia', 'facility': 'Federal Center of Traumatology, Orthopedics and Arthroplasty', 'geoPoint': {'lat': 56.13218, 'lon': 47.246}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}