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Open Access 01-12-2022 | Disc Herniation | Study protocol
Full-endoscopic versus conventional microsurgical therapy of lumbar disc herniation: a prospective, controlled, single-center, comprehensive cohort trial (FEMT-LDH trial)
Published in: Trials | Issue 1/2022
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Background
Lumbar disc herniation is one of the leading causes of chronic low back pain. Surgery remains the therapy of choice when conservative approaches fail. Full-endoscopic approaches represent a promising alternative to the well-established microsurgical technique. However, high-grade evidence comparing these techniques is still scarce.
Methods
Patients presenting with lumbar disc herniation will be included. The intervention group will obtain full-endoscopic disc decompression, whereas the control group will be treated by microsurgical disc decompression. We will apply a comprehensive cohort study design involving a randomized and a prospective non-randomized study arm. Patients who do not consent to be randomized will be assigned to the non-randomized arm. The primary outcome will be the Oswestry Disability Index (ODI). Secondary outcomes involve the visual analog scale (VAS) of pain and the SF-36 health questionnaire. Furthermore, clinical characteristics including duration of hospital stay, operation time, and complications as well as laboratory markers, such as C-reactive protein, white blood cell counts, and interleukin 6 will be determined and compared.
Discussion
This study will significantly contribute to the current evidence available in the literature by evaluating the outcome of the full-endoscopic technique against the gold standard for lumbar disc herniation in a clinically relevant study setup. Additionally, the study design allows us to include patients not willing to be randomized in a prospective parallel study arm and to evaluate the impact of randomization on outcomes and include. The results could help to improve the future therapy in patients suffering from lumbar disc herniation.
Trial registration
This study was prospectively registered in The German Clinical Trials Register (DRKS), a German WHO primary registry, under the registration number: DRKS00025786. Registered on July 7, 2021.