Clinical trial NCT00134537: Wallis Mechanical Normalization System for Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Degenerative Disc Disease of the lumbar spine
Lead sponsor: Zimmer Spine
Sponsor class: INDUSTRY
Collaborators: name: Zimmer Biomet
First posted: 2005-08-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.


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

Inclusion Criteria:

* Ages 18-60; male/female.
* Diagnosis of mild to moderate degenerative disc disease (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 computed tomography (CT), magnetic resonance imaging (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 for the current episode of back pain and had 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 or foraminotomy
* Radiographic evidence of DDD at L5-S1
* Radiographic confirmation of severe facet joint disease or degeneration.
* History of any lumbar disc treatment intended to remove the disc, e.g. surgery, intradiscal electrothermal therapy (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 dual-energy x-ray absorptiometry (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 the preceding three months
* Diabetes mellitus requiring daily insulin management
* Extreme obesity, as defined by National Institutes of Health (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 against a health care professional
* Life expectancy of less than three years
* History of any invasive malignancy (except for 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

Primary outcomes:
measure: To provide a safety cohort for the Prospective, Multi-center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Spine Specialists of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Arizona Institute for Minimally Invasive Spine Care
state: Arizona
city: Beverly Hills
country: United States
facility: Spine Source
state: California
city: Santa Monica
country: United States
facility: UCLA Spine Center
state: California
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
city: Thornton
country: United States
facility: The Spine Education & Research Institute
state: Colorado
city: Atlanta
country: United States
facility: Emory University Medical Center
state: Georgia
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopedics
state: Indiana
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Towson
country: United States
facility: Orthopaedic Associates
state: Maryland
city: Chesterfield
country: United States
facility: The Orthopedic Center of St. Louis
state: Missouri
city: Melville
country: United States
facility: Orthopedic Spine Care of Long Island
state: New York
city: Eugene
country: United States
facility: Orthopedic Spine Associates
state: Oregon
city: Willow Grove
country: United States
facility: The Orthopedic Specialty Center (Abington Hospital)
state: Pennsylvania
city: Austin
country: United States
facility: Central Texas Spine Institute
state: Texas
city: Plano
country: United States
facility: TBI/ Plano Presbyterian Hospital
state: Texas
Study officials:
References: