Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

Completed · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

The NuBac device is indicated for reconstruction following nucleotomy in skeletally mature patients at least 18 years of age with symptomatic single level degenerative disc disease (DDD) at L4/L5 only. DDD is defined as discogenic back pain with or without leg pain; with degeneration of the disc as confirmed by patient history, physical examination, radiographic studies showing: decreased disc height, contained herniated nucleus, vacuum phenomenon (dark disc) OR positive discography at the affected level. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level and should have failed at least six months of conservative, non-operative care. Demonstrate non-inferiority compared to ProDisc.

Key facts

Study ID

NCT00931515

Run by

Pioneer Surgical Technology, Inc.

People needed

30

Starts

2009-02-01

Expected to finish

2012-12-01

Last updated by the study team

2014-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• is at least 18 years of age and skeletally mature
• must have symptomatic single level degenerative disc disease at L4/5 requiring surgical treatment
• must have completed a minimum of six months of unsuccessful conservative, non-operative care
• must have discogenic back pain with or without leg pain
• must show radiographic confirmation using plain films, MRI, CT, myelogram or discography of one of the following: decreased disc height when compared to the adjacent level, contained herniated nucleus, or vacuum phenomenon (dark disc)
• must score at least 40% on the Oswestry Disability Index
• must score at least 4 on a 10cm Visual Analog Scale for back pain
• is able to comply with the protocol's follow-up schedule
• must understand and sign the informed consent document

You may not qualify if…

• symptomatic DDD at more than one level
• previous fusion at any lumbar level or laminectomy at the target level (discectomy, Intradiscal Electrothermal Annuloplasty, laminotomy, or nucleolysis performed > 6 months ago are permitted)
• clinically compromised vertebral bodies, at the affected level due to previous trauma, i.e., compression or burst fracture
• pars defect
• involved vertebral endplate dimensionally smaller than 34.5 mm in the medial-lateral direction and/or 27 mm in the anterior-posterior direction
• disc height less than 5 mm at the target level
• bony stenosis
• lytic spondylolisthesis, spondylolisthesis greater than 3mm
• lumbar scoliosis greater than 11 degrees.
• osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease
• Schmorl's nodes, an incomplete annulus, or endplates that are not intact
• spinal tumors
• symptomatic facet joint disease
• free fragment herniation confirmed radiographically
• isolated radicular compression syndrome, especially due to a disc herniation
• arachnoiditis
• active infection or surgical site infection
• is using any medication known to interfere with bone/soft tissue healing
• rheumatoid arthritis or other autoimmune disease
• systemic disease such as AIDS, HIV, hepatitis
• morbid obesity defined as body mass index (BMI) >40 or a weight more than 100 lbs over ideal body weight
• psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse
• active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years
• documented allergies to metal or plastic; i.e., cobalt, chromium, molybdenum, polyethylene, titanium or polyetheretherketone
• pregnancy, or interested in becoming pregnant within the next two years

Where it is running

• Spine Group Beverly Hills — Beverly Hills, California, United States
• Tower Orthopedics & Sports Medicine — Beverly Hills, California, United States
• Bergey Spine Institute — Colton, California, United States
• Loma Linda University - Faculty Physicians — Loma Linda, California, United States
• University of Colorado, Anschutz Outpatient Pavilion — Aurora, Colorado, United States
• The Spine Institute — Loveland, Colorado, United States
• Florida Orthopaedic Institute — Tampa, Florida, United States
• Bone & Joint Physicians — Oak Lawn, Illinois, United States
• Heartland Hand & Spine Orthopedic Center — Merriam, Kansas, United States
• Orthopaedic Surgical Associates — Marquette, Michigan, United States
• The Orthopedic Center of St. Louis — St Louis, Missouri, United States
• Buffalo Neurosurgery — Buffalo, New York, United States
• Southern New York NeuroSurgical Group — Johnson City, New York, United States
• Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
• NeuroSpine Institute — Eugene, Oregon, United States
• Neurospine Solutions, PC — Bristol, Tennessee, United States
• Milwaukee Spinal Specialists — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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