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 Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: NuBac; Device: Prodisc-L

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Total disc replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Improved Patient Function	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: Oswestry Disability Index score improved by at least 15 points; Device success; Neurological success; Absence of major complications; 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.	24 months

Collaborators and Investigators

• Sponsor: Pioneer Surgical Technology, Inc.
• Investigators: Principal Investigator: Matthew Songer, MD, Orthopedic Surgery Associates

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: June 29, 2009
• First Submitted That Met QC Criteria: June 30, 2009
• First Posted (ESTIMATE): July 2, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 14, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: DDD
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: N012009