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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02525120
• Date of registration: 12/08/2015
• Prospective Registration: No
• Primary sponsor: Minimus Spine, Inc
• Public title: Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
• Scientific title: Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
• Date of first enrolment: July 2015
• Target sample size: 49
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02525120
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Greece, Italy, Switzerland

Contacts

• Name: Josip Buric, MD
• Affiliation: Centro Chirurgico San Paolo, Pistoia, Italy

Key inclusion & exclusion criteria

Inclusion Criteria

1. Patient is willing to provide informed consent.

2. Clinical and radiographic evidence of one, and only one, symptomatic protruding or
extruded disc between L1 and S1.

3. The herniated disc should have a disc height of at least 50% that of the normal
adjacent disc levels, as determined by the investigator.

4. The signal intensity of the herniated disc material should be equal or greater than
the nucleus pulposus of the herniated disc.

5. The patient must have pain in a dermatomal distribution consistent with their
radiographic findings

6. Leg pain greater than or equal to 5 on the NRS scale

7. Symptoms for at least 6 weeks

8. Willingness to complete all follow-up evaluations

9. Patient aged 18-65 years

10. BMI<40

Exclusion Criteria:

1. Patients with a disc herniation extending past the facet joint

2. Presence of a non-contiguous disc fragment

3. Impairment of bladder/bowel function or motor impairment in the affected leg

4. An epidural steroid injection in the past 2 weeks

5. Previous discectomy, arthroplasty or fusion at any lumbar level

6. In patients with L5-S1 disc herniation, a congenital condition where the L5 vertebral
body is either fused to the sacrum or the L5-S1 disc is not fully formed as a normal
adult disc.

7. Symptomatic lumbar stenosis or listhesis

8. Symptomatic sacroiliac joint

9. Symptomatic foraminal stenosis due to severe degenerative disc disease

10. History of spinal tumor, fracture or infection

11. Females of childbearing age that are known to be pregnant or wishing to become
pregnant during the study

12. Fibromyalgia

13. Active infection

14. Metastatic cancer within the past 5 years

15. Pending litigation against a health care provider

16. More than 3 months of continuous sick leave prior to enrollment.

17. Known drug or alcohol abuse

18. Diagnosed psychiatric disease or psychological distress caused by recent trauma like
divorce, death of a member family or loss of a job

19. Patient known to be affected by favism (G6PD deficiency)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lumbar Disc Herniation

Intervention(s)

Device: Triojection

Procedure: Surgical discectomy

Primary Outcome(s)

Leg pain NRS [Time Frame: Baseline, 1 week, 1, 3 and 6 months.]

Secondary Outcome(s)

Cost Diary [Time Frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.]

Review of MRI images [Time Frame: Baseline and 6 and 24 months after treatment.]

Functional Score measured by RMDI. [Time Frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.]

Quality of Life measured by EQ-5D [Time Frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.]

Back pain NRS [Time Frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.]

Leg pain NRS [Time Frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.]

Patient Satisfaction via a survey [Time Frame: Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.]

Secondary ID(s)

1CP-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

genae international,ag