Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease

Study Overview
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Brief Summary
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The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.

Detailed Description
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This study is a multi-center, prospective, randomized, controlled trial. Patients will be randomized in 2 groups: Investigational group: a single level herniectomy procedure, followed by placement of the DIAMTM Spinal Stabilization System; Control group: a single level herniectomy procedure; After surgery, patients will be followed for a 2 years period with required follow up visits at 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years (optional visit).

Official Title
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Herniectomy vs. Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease

Conditions
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Sciatica, Back Pain

Intervention / Treatment
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* Device: DIAM™ Spinal Stabilization System
* Procedure: Herniectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a history of sciatica (radicular pain) for at least 6 weeks, but not more than 1 year secondary to one symptomatic lumbar disc herniation at the levels L2-L5 as confirmed by patient history and clinical evaluation, and without major neurological impairment (i.e. not less than M 3/5; Medical Research Council Classification); Has a history of continuous low back pain for no more than 1 year secondary to lumbar degenerative disc disease (intermittent back pain may occur for more than a year); Has pre-treatment back pain score greater than or equal to 3, concomitant with leg pain score greater than or equal to 6. Leg pain score must be greater than back pain score (pain intensity score measured on a 10 cm VAS scale); Has one symptomatic disc herniation: protrusion, extrusion or sequestration (Milette & Fardon, 2001) as confirmed by MRI at the target level; Evidence of disc degeneration ≤ Grade IV at the target and adjacent levels as confirmed by MRI (Pfirrmann, 2001); Has an Oswestry Disability Index (ODI) score ≥ 34%; Has been treated non-operatively (e.g. bed rest, physical therapy, medications, TENS, manipulation, hydrotherapy, acupressure/acupuncture, massage, bracing and/or spinal injections) for at least 6 continuous weeks unless strong clinical grounds for expediting surgery; Patient male or female, age 20-60 years inclusive and is skeletally mature; Is willing and able to comply with the study plan and able to provide an informed consent; Exclusion Criteria: Has a primary diagnosis of spinal disorder other than degenerative disc at the involved level; Has a symptomatic disc herniation at more than one lumbar level; Requires a herniectomy at more than one lumbar level; Has a disc degeneration at the treated and adjacent levels > Grade IV (Pfirrmann, 2001); Has a decrease of disc height ≥ 30% as measured by the center of the disc space, and compared to the disc space at the next superior spinal level; Has Modic changes on MRI greater than Grade I at the target level; Has Modic changes on MRI at the adjacent levels; Has an advanced degree of retrolisthesis as shown by lateral X-rays (> 25%, i.e. grade I as per Meyerding); Has a clinical evidence of lysis, antero listhesis or scoliosis (Cobb angle more than 10°); Has signs of segmental instability: more than 4 mm of translation or more than 10° angular motion between adjacent end plates (comparing flexion and extension views); Has congenital or iatrogenic posterior element insufficiency (e.g. facet resection, spondylolysis, pars fracture, or Spinal Bifida Occulta); Has had any previous lumbar spine surgery; Has a Waddell signs of inorganic behaviour score greater than or equal to 3; Has evidence of an active disruptive psychiatric disorder, cognitive impairment or other known condition, significant enough to impact the perception of pain, precludes surgical procedure, clinical evaluation and/or ability to evaluate treatment outcome as determined by investigator; Has a known allergy to silicone, polyethylene, or titanium; Is an alcohol and /or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse; Has obesity defined by BMI greater than or equal to 35; Inability to complete the questionnaires; Planned pregnancy during the course of the study; Previous enrollment into a spine study; Vulnerable patients or unable to exercise free informed consent;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational group<br>Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System | Device: DIAM™ Spinal Stabilization System<br>* The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.<br>|
| Active Comparator: Control group<br>Single level herniectomy | Procedure: Herniectomy<br>* Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS). | The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI). | The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI). The ODI is a low back pain disability questionnaire used to measure a patient's permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability. | 12 Months |