Clinical trial NCT04855682: EuroPainClinicsStudy X
Official title: EuroPainClinicsStudy X (Minimally Invasive Spinal Surgical Approaches)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Back Pain
Lead sponsor: Europainclinics z.ú.
Sponsor class: OTHER
Collaborators: name: R-CLINIC s.r.o.
name: Faculty Hospital Nitra
name: Slovak Academy of Sciences
name: University Hospital Bratislava
First posted: 2021-04-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.

Brief summary: Non-interventional, retrospective-prospective cohort study based on the collection of data and their evaluation after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.

Detailed description: The aim of this clinical study is to compare the benefits and complications after minimally invasive spinal procedures in patients with acute lumbosacral radicular syndrome caused by a herniated disc compressing the spinal neural structures.

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.

Eligibility criteria: Inclusion Criteria:

* patient age 18-60 years
* first spinal surgery in the areas L1-S1
* signed informed consent for the participation in the study

Exclusion Criteria:

* patients with a history of other back problems (compression fracture, spondylitis, tumour)
* 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

Primary outcomes:
measure: Fat degeneration of muscles
timeFrame: 12 months after procedure
measure: Fat degeneration of muscles
timeFrame: 24 months after procedure
measure: Oswestry disability index (ODI)
timeFrame: 12 months and 24 months after procedure
measure: Oswestry disability index (ODI)
timeFrame: 24 months after procedure
measure: EQ-5D-5L
timeFrame: 12 months after procedure
measure: EQ-5D-5L
timeFrame: 24 months after procedure
Secondary outcomes:
measure: Usage of painkillers before and after the procedures
timeFrame: 12 months after procedure
measure: Usage of painkillers before and after the procedures
timeFrame: 24 months after procedure
measure: Occurrence of early and late post-surgery complications
timeFrame: 12 months after procedure
measure: Occurrence of early and late post-surgery complications
timeFrame: 24 months after procedure
Other outcomes:
Locations:
city: Bardejov
country: Slovakia
facility: R - Clinic s.r.o.
city: Bardejov
country: Slovakia
facility: R - Clinic s.r.o.
city: Bardejov
country: Slovakia
facility: R - Clinic s.r.o.
Study officials:
affiliation: clinical monitor
name: Miroslav Burianek, MD MBA
role: STUDY_CHAIR
References: