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Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
This study is currently recruiting participants.
Verified by Pioneer Surgical Technology, Inc., February 2010
First Received: June 29, 2009   Last Updated: February 15, 2010   History of Changes
Sponsor: Pioneer Surgical Technology, Inc.
Information provided by: Pioneer Surgical Technology, Inc.
ClinicalTrials.gov Identifier: NCT00931515
  Purpose

The NuBac device is indicated for reconstruction following nucleectomy 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

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Active Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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:
  • Improved patient function [ Time Frame: 6 weeks, 3, 6, 12, 24 months, annually thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2009
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NUBAC
    1:1 v control
Detailed Description:

STUDY DESIGN:

Multi-center, 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 (discectomy, laminectomy/laminotomy, IDET, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931515

Contacts
Contact: Jon Gilbert (906) 226-9909 jongilbert@pioneersurgical.com

Locations
United States, California
Spine Group Beverly Hills Recruiting
Beverly Hills, California, United States, 90211
Contact: Liz Homsher     310-385-8010        
Principal Investigator: John J Regan, MD            
Sub-Investigator: Todd Lanman, MD            
Tower Orthopedics & Sports Medicine Recruiting
Beverly Hills, California, United States, 90211
Contact: Lacey Feldman, CRC     310-855-0751 ext 2109     lacey.feldman@olympiamc.com    
Principal Investigator: Carl Lauryssen, MD            
The Cedars Sinai Institute for Spinal Disorders Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Neel Anand, MD            
The Cedars Sinai Institute for Spinal Disorders Recruiting
Los Angeles, California, United States, 90048
Contact: Helen Cambron     310-423-9709     cambronh@cshs.org    
Sub-Investigator: Patrick Johnson, MD            
United States, Colorado
The Spine Institute Recruiting
Loveland, Colorado, United States, 80538
Contact: Nicole Rittenhouse, MA, CCRC     970-669-8881 ext 229     nrittenhouse@spinerevolution.com    
Contact: Kenneth Pettine, MD         kpettine@spinerevolution.com    
Principal Investigator: Kenneth A Pettine, MD            
Sub-Investigator: W. Carlton Reckling, MD            
United States, Florida
Florida Spine Institute Recruiting
Clearwater, Florida, United States, 33765
Florida Orthopaedic Institute Recruiting
Tampa, Florida, United States, 33607
United States, Illinois
Bone & Joint Physicians Recruiting
Oak Lawn, Illinois, United States, 60453
Principal Investigator: George Miz, MD            
United States, Kansas
Heartland Hand & Spine Orthopedic Center Recruiting
Overland Park, Kansas, United States, 66211
Contact: Cindy Barrack     913-649-7300        
Principal Investigator: William Reed, MD            
Sub-Investigator: Alexander Bailey, MD            
Sub-Investigator: Glenn Amundson, MD            
United States, Michigan
Orthopaedic Surgical Associates Recruiting
Marquette, Michigan, United States, 49855
United States, Missouri
The Orthopedic Center of St. Louis Recruiting
St. Louis, Missouri, United States, 63017
Contact: Francine Schranck     314-392-5089        
Principal Investigator: Matthew Gornet, MD            
Sub-Investigator: Brett Taylor, MD            
United States, New York
Buffalo Neurosurgery Recruiting
Buffalo, New York, United States, 14224
Contact: Robin Venditti     716-677-6000        
Principal Investigator: Jeffrey Lewis, MD            
Sub-Investigator: Douglas Moreland, MD            
Southern New York NeuroSurgical Group Recruiting
Johnson City, New York, United States, 13790
Contact: Research Coordinator     607-798-0718        
Principal Investigator: Saeed Bajwa, MD            
Sub-Investigator: Khalid Sethi, MD            
United States, North Carolina
Carolina Neurosurgery and Spine Associates Recruiting
Charlotte, North Carolina, United States, 28204
United States, Oregon
NeuroSpine Institute Recruiting
Eugene, Oregon, United States, 97401
United States, Texas
Brain & Spine Center of Texas Recruiting
Plano, Texas, United States, 75093
Principal Investigator: Joseph Stachniak, MD            
United States, Wisconsin
Milwaukee Spinal Specialists Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Marty Naber, PA     414-961-2225        
Principal Investigator: Stephen Robbins, MD            
Sponsors and Collaborators
Pioneer Surgical Technology, Inc.
  More Information

No publications provided

Responsible Party: Pioneer Surgical Technology, Inc. ( Jonathan Gilbert / VP Regulatory/Clinical Affairs )
ClinicalTrials.gov Identifier: NCT00931515     History of Changes
Other Study ID Numbers: N012009
Study First Received: June 29, 2009
Last Updated: February 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pioneer Surgical Technology, Inc.:
DDD

ClinicalTrials.gov processed this record on September 02, 2010