Full-Endoscopic versus conventional Microsurgical Therapy of Lumbar Disc Herniation: a prospective, controlled, single-center, comprehensive cohort trial (FEMT-LDH trial)

Phase 3

Recruiting

Conditions: M51
M99.4
Other intervertebral disc disorders
Connective tissue stenosis of neural canal

Registration Number: DRKS00025786

Lead Sponsor: Joimax GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 174

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

-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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the Oswestry Disability Index (ODI)<br><br>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.<br><br>The ODI is assessed preoperatively, immediately postoperatively, after 24 hours, 48 ??hours, 3 weeks, 1 year, 2 years and 5 years post-op.

Secondary Outcome Measures

Name	Time	Method
-Visual analogue scale of pain (questionnaire; comparison of pre- and postoperative values)<br>-SF-36 (health questionnaire; comparison of pre- and postoperative values)<br>-Duration of the hospital stay (in days)<br>-Duration of the operation<br>-Peri- and postoperative complications<br>-Comparison of the pre- and postoperative laboratory blood values ??for the evaluation of muscle damage:<br>(Creatine kinase (CK), myoglobin (Mb), erythrocyte sedimentation rate, CK / AST quotient, procalcitonin (PCT), C-reactive protein (CRP), white blood cell count (WBC), IL-6