M51 M99.4
Conditions
Interventions
Group 1: full-endoscopic disc decompression (randomized)
Group 2: microsurgical disc decompression (randomized)
Group 3: full-endoscopic disc decompression (non-randomized)
Group 4: microsurgical disc
Sponsors
Joimax GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: -Patients for whom the medical indication for lumbar disc surgery is given and conservative therapy was unsuccessful -Gender: male or female -Minimum age: 18 years -Maximum age: 75 years
Exclusion criteria
Exclusion criteria: -Patients under 18 years of age -Patients incapable of giving consent -Patients who contact the Loretto Hospital in advance with the request of one of the two surgical methods (these patients will be assigned to the respective non-randomized group if they consent to participate in the study) -Patients who do not agree to follow-up appointments 3 weeks, 1 year, 2 years and 5 years post-op -Breastfeeding, pregnant or childbearing women who plan to become pregnant while participating in the study -Massively sequestered disc prolapse -Prolapse in the upper lumbar region (L2 or above) -Patients with previous prolapse and revision surgery -Prolapse affects several segments -Patients = 120 kg -Patients with an active infection process -Patients with other serious, especially malignant, diseases -Patients with other severe spinal disorders, such as osteoarthritis, osteopenia, osteoporosis or osteomalacia -Patients with congenital malformations of the spine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the Oswestry Disability Index (ODI) The Oswestry Disability Index (ODI) is a questionnaire for evaluating functional disorders caused by back pain. The German version published in 2006 (Mannion et al., 2006), the ODQ-D (Oswestry Disability Questionnaire- German), is scientifically recognized and researchers use it regularly in studies on back pain. The questionnaire is divided into 10 sections, each with 6 possible answers with point values ??of 0-5 points. The most appropriate answer should be ticked. As a result, the number of points achieved is set in relation to the maximum number of points and given as a percentage. The ODI is assessed preoperatively, immediately postoperatively, after 24 hours, 48 ??hours, 3 weeks, 1 year, 2 years and 5 years post-op. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Visual analogue scale of pain (questionnaire; comparison of pre- and postoperative values) -SF-36 (health questionnaire; comparison of pre- and postoperative values) -Duration of the hospital stay (in days) -Duration of the operation -Peri- and postoperative complications -Comparison of the pre- and postoperative laboratory blood values ??for the evaluation of muscle damage: (Creatine kinase (CK), myoglobin (Mb), erythrocyte sedimentation rate, CK / AST quotient, procalcitonin (PCT), C-reactive protein (CRP), white blood cell count (WBC), IL-6 | — |
Countries
Germany
Contacts
Public ContactGernot Lang
Loretto Krankenhaus Freiburg
Outcome results
None listed