Lumbar Disc Herniation Clinical Trial
Official title:
Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
The primary objective of this study is to compare the early clinical outcomes following non-surgical treatment with Triojection® to surgical discectomy. Early is defined as less than or equal to 6 months.
The objective of this study is to compare clinical, economic and safety outcomes between
Triojection and surgical discectomy. The study will include two follow-up phases: 1) an
initial follow-up period during the first 6 months after treatment and (2) a long-term
follow-up lasting an additional 18 months (2 years total).
The hypothesis is that over the first six months after treatment, Triojection® will be
non-inferior to discectomy with respect to the improvement in leg pain. This will be
demonstrated using a non-inferiority margin of 19.4 points on the difference between baseline
leg pain score and the average leg pain score recorded at 1 week, 1, 3 and 6 months.
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