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Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931515
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : May 15, 2014
Last Update Posted : May 26, 2014
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.

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.

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: NuBac Device: Prodisc-L Not Applicable

Detailed Description:


Multicenter, prospective, randomized (1:1), controlled study comparing the artificial nucleus to ProDisc. After implanting artificial nucleus in two patients during the training session, enrollment of randomized patients shall begin. The study is expected to be completed in four years.


10 - 20 investigational sites, 1 to 2 investigators per site, approximately 20-40 patients per site

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Study Start Date : February 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NuBac
NuBac device implanted at the L4/5 level
Device: NuBac
NuBac device implanted at the L4/5 level.
Other Names:
  • nucleus replacement
  • disc arthroplasty

Active Comparator: Prodisc-L
Prodisc-L implanted at the L4/5 level.
Device: Prodisc-L
Prodisc-L implanted at the L4/5 level.
Other Name: Total disc replacement

Primary Outcome Measures :
  1. Participants With Improved Patient Function [ Time Frame: 24 months ]

    The comparison of results was based on the proportion of participants with improved outcomes.

    The primary efficacy variable was treatment success based on the following criteria:

    1. Oswestry Disability Index score improved by at least 15 points
    2. Device success
    3. Neurological success
    4. Absence of major complications
    5. Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931515

Show Show 17 study locations
Sponsors and Collaborators
Pioneer Surgical Technology, Inc.
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Principal Investigator: Matthew Songer, MD Orthopedic Surgery Associates
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Responsible Party: Pioneer Surgical Technology, Inc. Identifier: NCT00931515    
Other Study ID Numbers: N012009
First Posted: July 2, 2009    Key Record Dates
Results First Posted: May 15, 2014
Last Update Posted: May 26, 2014
Last Verified: May 2014
Keywords provided by Pioneer Surgical Technology, Inc.:
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases