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Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier:
NCT00931515
First received: June 29, 2009
Last updated: May 14, 2014
Last verified: May 2014

June 29, 2009
May 14, 2014
February 2009
December 2012   (final data collection date for primary outcome measure)
Participants With Improved Patient Function [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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.
Improved patient function [ Time Frame: 6 weeks, 3, 6, 12, 24 months, annually thereafter ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00931515 on ClinicalTrials.gov Archive Site
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Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

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.

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, enrollment of randomized patients shall begin. The study is expected to be completed in four years.

NUMBER OF INVESTIGATIONAL SITES and INVESTIGATORS:

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Degenerative Disc Disease
  • Device: NuBac
    NuBac device implanted at the L4/5 level.
    Other Names:
    • nucleus replacement
    • disc arthroplasty
  • Device: Prodisc-L
    Prodisc-L implanted at the L4/5 level.
    Other Name: Total disc replacement
  • Experimental: NuBac
    NuBac device implanted at the L4/5 level
    Intervention: Device: NuBac
  • Active Comparator: Prodisc-L
    Prodisc-L implanted at the L4/5 level.
    Intervention: Device: Prodisc-L
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00931515
N012009
Yes
Pioneer Surgical Technology, Inc.
Pioneer Surgical Technology, Inc.
Not Provided
Principal Investigator: Matthew Songer, MD Orthopedic Surgery Associates
Pioneer Surgical Technology, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP