Full‑endoscopic versus conventional microsurgical therapy of lumbar disc herniation: a prospective, controlled, single‑center, comprehensive cohort trial (FEMT‑LDH trial)

Trials, 2022 · DOI: https://doi.org/10.1186/s13063-022-06892-8 · Published: November 3, 2022

Surgery Orthopedics Research Methodology & Design

Simple Explanation

The study compares full-endoscopic disc decompression with microsurgical disc decompression for lumbar disc herniation. The study includes both a randomized and a non-randomized study arm to evaluate the impact of randomization on outcomes. The primary outcome is the Oswestry Disability Index (ODI), with secondary outcomes including pain and health questionnaires.

Study Duration

Not specified

Participants

Patients presenting with lumbar disc herniation

Evidence Level

Prospective, controlled, single-center, comprehensive cohort trial

Key Findings

1
The study aims to compare the results of lumbar discectomies using the full-endoscopic technique via the interlaminar and trans-foraminal access with those of the conventional microsurgical technique, particularly with regard to iatrogenic muscle trauma and patient-related outcome measures.
2
The investigation will take place as a “comprehensive cohort study,” including a randomized and non-randomized study arm comparing the endoscopic versus microsurgical decompression to provide a high level of evidence.
3
Patient-reported outcome measures will be evaluated preoperatively, immediately postoperatively, after 24 h, 48 h, 3 weeks, 1 year, 2 years, and 5 years post-operatively to provide the necessary and currently lacking long-term data.

Research Summary

This study protocol outlines a comprehensive cohort trial comparing full-endoscopic and microsurgical techniques for lumbar disc herniation treatment. The study includes a randomized and a non-randomized arm, focusing on patient-reported outcomes, clinical characteristics, and laboratory markers. The primary outcome is the Oswestry Disability Index, with long-term follow-up data collected over five years.

Practical Implications

Improved treatment strategies

The results could help to improve the future therapy in patients suffering from lumbar disc herniation.

Evidence-based practice

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.

Understanding randomization impact

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.

Study Limitations

1
Potential for conversion from full-endoscopic to microsurgical technique during surgery.
2
Laboratory markers are surrogate markers and might fail to show clinical relevancy.
3
Generalizability may be limited due to the single-center design and one surgeon performing the interventions.

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