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Wallis Mechanical Normalization System for Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Zimmer Spine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Zimmer Spine
ClinicalTrials.gov Identifier:
NCT00134537
First received: August 23, 2005
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Low Back Pain
Device: Interspinous process and dynamic stabilization
Device: Conservative Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Zimmer Spine:

Primary Outcome Measures:
  • 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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2004
Estimated Study Completion Date: April 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Interspinous process and dynamic stabilization
Device: Interspinous process and dynamic stabilization
Interspinous process and dynamic stabilization
Active Comparator: 2
Conservative Care
Device: Conservative Care
Medication, exercise and spinal injections

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134537

Locations
United States, Arizona
Arizona Institute for Minimally Invasive Spine Care
Phoenix, Arizona, United States, 85020
Spine Specialists of Arizona
Phoenix, Arizona, United States, 85015
United States, California
Spine Source
Beverly Hills, California, United States, 90212
UCLA Spine Center
Santa Monica, California, United States, 90404
United States, Colorado
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80304
The Spine Education & Research Institute
Thornton, Colorado, United States, 80229
United States, Georgia
Emory University Medical Center
Atlanta, Georgia, United States, 30329
United States, Illinois
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States, 60053
United States, Indiana
Fort Wayne Orthopedics
Fort Wayne, Indiana, United States, 46804
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Orthopaedic Associates
Towson, Maryland, United States, 21204
United States, Missouri
The Orthopedic Center of St. Louis
Chesterfield, Missouri, United States, 63017
United States, New York
Orthopedic Spine Care of Long Island
Melville, New York, United States, 11747
United States, Oregon
Orthopedic Spine Associates
Eugene, Oregon, United States, 97401
United States, Pennsylvania
The Orthopedic Specialty Center (Abington Hospital)
Willow Grove, Pennsylvania, United States, 19090
United States, Texas
Central Texas Spine Institute
Austin, Texas, United States, 78731
TBI/ Plano Presbyterian Hospital
Plano, Texas, United States, 75093
Sponsors and Collaborators
Zimmer Spine
Zimmer, Inc.
  More Information

No publications provided

Responsible Party: Zimmer Spine
ClinicalTrials.gov Identifier: NCT00134537     History of Changes
Other Study ID Numbers: SN002-001-05
Study First Received: August 23, 2005
Last Updated: October 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer Spine:
Degenerative Disc Disease of the lumbar spine

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014