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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02525120
• Other study ID #: 1CP-1
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: May 2020

Study information

• Verified date: June 2018
• Source: Minimus Spine, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: May 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

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.

Locations

Country	Name	City	State
Greece	University General Hospital Attikon	Athens	Haidari
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo	Lombardia
Switzerland	Ospedale Regionale di Lugano- Civico e Italiano	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
Minimus Spine, Inc	genae international,ag

Countries where clinical trial is conducted

Greece,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	All adverse events are to be reported, per ISO 14155.	Through 24 months
Primary	Leg pain NRS	The primary outcome measure will be the amount of improvement in leg pain after treatment. This will be determined by taking the difference between the baseline score and the average of the post-treatment scores at 1 week, 1, 3 and 6 months.	Baseline, 1 week, 1, 3 and 6 months.
Secondary	Leg pain NRS	Leg pain Numerical Rating Scale (NRS) at each visit.	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Secondary	Back pain NRS	Back pain Numerical Rating Scale (NRS) at each visit	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Secondary	Functional Score measured by RMDI.	Roland Morris Disability Index. A 24 question survey asking the subject if they have difficulty with various activities of daily living.	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Secondary	Quality of Life measured by EQ-5D	EQ-5D is a validated survey asking the subject 5 multiple choice questions and to indicate their general health status on a scale of 0-100.	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Secondary	Patient Satisfaction via a survey	Brief questionnaire asking patients to rate their level of satisfaction.	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Secondary	Cost Diary	Survey asking patients to detail their medical expenses, work status, time off work etc.	Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.
Secondary	Review of MRI images	Blinded, independent MRI review to determine reduction in disc herniation following treatment and evaluate index and adjacent levels for evidence of degeneration.	Baseline and 6 and 24 months after treatment.