Compare improvement in low back pain with Wallis to exercise and injections.

Condition	Intervention
Degenerative Disc Disease of the lumbar spine	Device: Interspinous process dynamic stabilization  Device: Conservative management of medication, exercise & spinal injections

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Subjects must meet all inclusion and exclusion criteria listed below for participation in the study.

• Age 18-60 Male/Female

• Diagnosis of mild to moderate DDD, which requires:

  • Back pain of at least 30/100 as measured on a visual analog scale, with or without leg (radicular) pain; and Radiographic confirmation of the following, as determined by CT, MRI, discography, plain film, myelography and/or flexion/extension films: up to Modic I changes on MRI, with decreased disc height up to 50% of adjacent level, and no significant osteophytes; with or without a contained disc herniation.
• Candidate for either surgery with Wallis or aggressive conservative management.
• Requires treatment at one or two lumbar levels between L1 and L5.
• Experienced symptoms for at least three months without significant resolution.
• Has undergone a regimen of at least four weeks of anti-inflammatory medication just prior to enrollment and exposure to physical therapy.
• Minimum baseline Oswestry Score of 30% (15/50).
• Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
• Voluntarily signs the Subject Informed Consent.

Exclusion Criteria:

• Significant neuroforaminal compression requiring discectomy (bony decompression will be allowed).
• Radiographic confirmation of severe facet joint disease or degeneration.
• History of any lumbar disc treatment intended to remove the disc, e.g. surgery, IDET, laser or enzymes such as chymopapain.
• Clinically compromised vertebral bodies at the affected level due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.
• Unwilling to comply with 8 weeks of physical therapy.
• Subject refuses to consider epidural or facet injections for leg or back pain.
• Active systemic infection or infection at the operative site;
• Osteoporosis. The Simple Calculated Osteoporosis Risk Estimation (SCORE) questionnaire will be used to screen subjects for osteoporosis; subjects whose screening suggests risk will undergo a DEXA scan. Subjects will be excluded if the DEXA scan results indicate a T-score equal to or worse than –2.5, in accordance with the World Health Organization definition of osteoporosis;
• Paget’s disease, osteomalacia, or any other metabolic bone disease other than osteoporosis, which is addressed above;
• Rheumatoid arthritis, lupus, or other autoimmune disease;
• AIDS, HIV, or Hepatitis;
• Known allergy to titanium, polyetheretherketone, or polyester;
• Current pathological lesions, such as tumor;
• Congenital lumbar spinal stenosis;
• Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films.
• Cauda Equina syndrome;
• Pregnant at time of enrollment or with plans to become pregnant within the next three years;
• Concomitant conditions requiring steroid treatment or prior steroid usage for more than one of preceding three months;
• Diabetes mellitus requiring daily insulin management;
• Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 35);
• Fusion previously performed at the same or an adjacent level, or other instrumented spinal surgery at the operative level;
• Prior participation in study of any experimental spinal implant or treatment;
• Pending litigation relating to spinal injury;
• Life expectancy of less than three years;
• History of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for at least 5 years;
• Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention;
• Spondylolysis;
• Translation greater than 2 mm at the symptomatic level;
• Significant scoliosis (Cobb angle > 25 degrees) or scoliosis otherwise requiring surgical correction;
• Kyphosis requiring surgical correction.

Please refer to this study by ClinicalTrials.gov identifier  NCT00134537

Jamie Provenzano      512.533.1029    jamie.provenzano@abbottspine.com

Arizona
      TBI/ Plano Presbyterian Hospital, Phoenix,  Arizona,  85015,  United States; Not yet recruiting
      Spine Specialists of Arizona, Phoenix,  Arizona,  85015,  United States; Not yet recruiting
      Arizona Institute for MI Spine Care, Phoenix,  Arizona,  85020,  United States; Not yet recruiting
California
      UCLA Spine Center, Santa Monica,  California,  90404,  United States; Not yet recruiting
      Spine Source, Beverly Hills,  California,  90212,  United States; Recruiting
Colorado
      Center for Spinal Disorders, Thornton,  Colorado,  80229,  United States; Not yet recruiting
      Boulder Neurosurgical Associates, Boulder,  Colorado,  80304,  United States; Not yet recruiting
Georgia
      Emory University Medical Center, Atlanta,  Georgia,  30329,  United States; Not yet recruiting
Illinois
      Illinois Neuro-Spine Center, Aurora,  Illinois,  60504,  United States; Not yet recruiting
      Illinois Bone & Joint Institute, Morton Grove,  Illinois,  60053,  United States; Not yet recruiting
Indiana
      Fort Wayne Orthopedics, Fort Wayne,  Indiana,  46804,  United States; Not yet recruiting
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States; Not yet recruiting
Maryland
      Greater Baltimore Medical Center, Baltimore,  Maryland,  21204,  United States; Not yet recruiting
      Orthopaedic Associates, Towson,  Maryland,  21204,  United States; Recruiting
Oregon
      Orthopedic Spine Associates, Eugene,  Oregon,  97401,  United States; Recruiting
Pennsylvania
      The Orthopedic Specialty Center (Abington Hospital), Willow Grove,  Pennsylvania,  19090-1711,  United States; Recruiting

Study ID Numbers:  SN002-001-04
Last Updated:  August 24, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00134537
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30