NCT02525120

Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Minimus Spine, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
DEVICE	Triojection	Triojection is system intended to deliver a specific amount of ozone to a herniated disc.
PROCEDURE	Surgical discectomy	Patients will receive surgery to remove the herniated disc material.

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-12-01
• Completion: 2020-05-01
• First posted: 2015-08-17
• Last updated: 2018-06-06

Locations

3 sites across 3 countries: Greece, Italy, Switzerland