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
  Purpose

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 Intervention
Degenerative Disc Disease
Device: NuBac
Device: Prodisc-L

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

Further study details as provided by Pioneer Surgical Technology, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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, 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931515

Locations
United States, California
Spine Group Beverly Hills
Beverly Hills, California, United States, 90211
Tower Orthopedics & Sports Medicine
Beverly Hills, California, United States, 90211
Bergey Spine Institute
Colton, California, United States, 92324
Loma Linda University - Faculty Physicians
Loma Linda, California, United States, 92354
United States, Colorado
University of Colorado, Anschutz Outpatient Pavilion
Aurora, Colorado, United States, 80045
The Spine Institute
Loveland, Colorado, United States, 80538
United States, Florida
Florida Orthopaedic Institute
Tampa, Florida, United States, 33637
United States, Illinois
Bone & Joint Physicians
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Heartland Hand & Spine Orthopedic Center
Merriam, Kansas, United States, 66204
United States, Michigan
Orthopaedic Surgical Associates
Marquette, Michigan, United States, 49855
United States, Missouri
The Orthopedic Center of St. Louis
St. Louis, Missouri, United States, 63017
United States, New York
Buffalo Neurosurgery
Buffalo, New York, United States, 14224
Southern New York NeuroSurgical Group
Johnson City, New York, United States, 13790
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28204
United States, Oregon
NeuroSpine Institute
Eugene, Oregon, United States, 97401
United States, Tennessee
Neurospine Solutions, PC
Bristol, Tennessee, United States, 37620
United States, Wisconsin
Milwaukee Spinal Specialists
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Pioneer Surgical Technology, Inc.
Investigators
Principal Investigator: Matthew Songer, MD Orthopedic Surgery Associates
  More Information

No publications provided

Responsible Party: Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier: NCT00931515     History of Changes
Other Study ID Numbers: N012009
Study First Received: June 29, 2009
Results First Received: April 15, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pioneer Surgical Technology, Inc.:
DDD

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014