Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
180 participants
OBSERVATIONAL
2021-07-15
2024-04-15
Brief Summary
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Detailed Description
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The study only works with patient data provided by the outpatient clinic for research analysis in the EPCS IV clinical study. All patient data are encrypted during collection and evaluation during the study, and stored in an encrypted database. The data will be evaluated by an independent institution - The Institute of Measurement of the Slovak Academy of Sciences.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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A
Endoscopic discectomy
Retrospective observation after 24 months after the spinal procedure
Retrospective evaluation of patients before the procedure, and prospective evaluation of patients 24 months after the spinal procedure, comparing the MRI changes and procedure impact on fatty muscle degeneration process
Retrospective observation after 12 months after the spinal procedure
Retrospective evaluation of the patient status before the procedure, and prospective evaluation of patients for 12 months after the spinal procedure, comparing the MRI changes
Prospective evaluation of patients after 12 and 24 months after the spinal procedure
Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes
B
Microdisectomy
Retrospective observation after 24 months after the spinal procedure
Retrospective evaluation of patients before the procedure, and prospective evaluation of patients 24 months after the spinal procedure, comparing the MRI changes and procedure impact on fatty muscle degeneration process
Retrospective observation after 12 months after the spinal procedure
Retrospective evaluation of the patient status before the procedure, and prospective evaluation of patients for 12 months after the spinal procedure, comparing the MRI changes
Prospective evaluation of patients after 12 and 24 months after the spinal procedure
Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes
C
Hemilaminectomy
Retrospective observation after 24 months after the spinal procedure
Retrospective evaluation of patients before the procedure, and prospective evaluation of patients 24 months after the spinal procedure, comparing the MRI changes and procedure impact on fatty muscle degeneration process
Retrospective observation after 12 months after the spinal procedure
Retrospective evaluation of the patient status before the procedure, and prospective evaluation of patients for 12 months after the spinal procedure, comparing the MRI changes
Prospective evaluation of patients after 12 and 24 months after the spinal procedure
Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes
Interventions
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Retrospective observation after 24 months after the spinal procedure
Retrospective evaluation of patients before the procedure, and prospective evaluation of patients 24 months after the spinal procedure, comparing the MRI changes and procedure impact on fatty muscle degeneration process
Retrospective observation after 12 months after the spinal procedure
Retrospective evaluation of the patient status before the procedure, and prospective evaluation of patients for 12 months after the spinal procedure, comparing the MRI changes
Prospective evaluation of patients after 12 and 24 months after the spinal procedure
Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* first spinal surgery in the areas L1-S1
* signed informed consent for the participation in the study
Exclusion Criteria
* patients after repeated spinal surgeries
* patients with a systemic disease affecting the muscles elite athletes
* patients who disagree to participate in the study
* women with a positive pregnancy test or women planning on becoming pregnant
18 Years
80 Years
ALL
No
Sponsors
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R-CLINIC s.r.o.
OTHER
Faculty Hospital Nitra
OTHER
Slovak Academy of Sciences
OTHER_GOV
University Hospital Bratislava
OTHER
Europainclinics z.ú.
OTHER
Responsible Party
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MUDr. Miroslav Buriánek MBA, MUDr. Robert Rapčan FIPP
Clinical Research Manager
Principal Investigators
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Miroslav Burianek, MD MBA
Role: STUDY_CHAIR
clinical monitor
Locations
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R - Clinic s.r.o.
Bardejov, , Slovakia
R - Clinic s.r.o.
Bardejov, , Slovakia
R - Clinic s.r.o.
Bardejov, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Ladislav Kočan, MD PhD
Role: primary
Robert Rapčan, MD FIPP
Role: primary
Miroslav Burianek, MD MBA
Role: backup
Other Identifiers
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4184/2021/ODDZ-11156
Identifier Type: -
Identifier Source: org_study_id
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