Status:
COMPLETED
Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Lead Sponsor:
Pioneer Surgical Technology, Inc.
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
STUDY DESIGN: Multicenter, prospective, randomized (1:1), controlled study comparing the artificial nucleus to ProDisc. After implanting artificial nucleus in two patients during the training session...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- prisoner
- involvement in an investigational drug or device study within 30 days
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00931515
Start Date
February 1 2009
End Date
December 1 2012
Last Update
May 26 2014
Active Locations (17)
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1
Spine Group Beverly Hills
Beverly Hills, California, United States, 90211
2
Tower Orthopedics & Sports Medicine
Beverly Hills, California, United States, 90211
3
Bergey Spine Institute
Colton, California, United States, 92324
4
Loma Linda University - Faculty Physicians
Loma Linda, California, United States, 92354