Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
Condition: Sciatica; Back Pain
MeSH terms: Sciatica
Intervention: DIAM™ Spinal Stabilization System; Herniectomy
Intervention description: 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.; 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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;