Wallis Mechanical Normalization System for Low Back Pain

Low Back Pain Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00134537
• Other study ID #: SN002-001-05
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 23, 2005
• Last updated: October 3, 2011
• Start date: November 2004
• Est. completion date: April 2012

Study information

• Verified date: October 2011
• Source: Zimmer Spine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Interspinous process and dynamic stabilization
Interspinous process and dynamic stabilization
• Conservative Care
Medication, exercise and spinal injections

Locations

Country	Name	City	State
United States	Emory University Medical Center	Atlanta	Georgia
United States	Central Texas Spine Institute	Austin	Texas
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Spine Source	Beverly Hills	California
United States	Boulder Neurosurgical Associates	Boulder	Colorado
United States	The Orthopedic Center of St. Louis	Chesterfield	Missouri
United States	Orthopedic Spine Associates	Eugene	Oregon
United States	Fort Wayne Orthopedics	Fort Wayne	Indiana
United States	Orthopedic Spine Care of Long Island	Melville	New York
United States	Illinois Bone & Joint Institute	Morton Grove	Illinois
United States	Arizona Institute for Minimally Invasive Spine Care	Phoenix	Arizona
United States	Spine Specialists of Arizona	Phoenix	Arizona
United States	TBI/ Plano Presbyterian Hospital	Plano	Texas
United States	UCLA Spine Center	Santa Monica	California
United States	The Spine Education & Research Institute	Thornton	Colorado
United States	Orthopaedic Associates	Towson	Maryland
United States	The Orthopedic Specialty Center (Abington Hospital)	Willow Grove	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Spine	Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 months	Yes