Status:
UNKNOWN
Wallis Mechanical Normalization System for Low Back Pain
Lead Sponsor:
Zimmer Spine
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Low Back Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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
Inclusion
- Subjects must meet all inclusion and exclusion criteria listed below for participation in the study.
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00134537
Start Date
November 1 2004
End Date
April 1 2012
Last Update
October 4 2011
Active Locations (17)
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1
Spine Specialists of Arizona
Phoenix, Arizona, United States, 85015
2
Arizona Institute for Minimally Invasive Spine Care
Phoenix, Arizona, United States, 85020
3
Spine Source
Beverly Hills, California, United States, 90212
4
UCLA Spine Center
Santa Monica, California, United States, 90404