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Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NuBac
Prodisc-L
Sponsored by
Pioneer Surgical Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring DDD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spine Group Beverly Hills
  • Tower Orthopedics & Sports Medicine
  • Bergey Spine Institute
  • Loma Linda University - Faculty Physicians
  • University of Colorado, Anschutz Outpatient Pavilion
  • The Spine Institute
  • Florida Orthopaedic Institute
  • Bone & Joint Physicians
  • Heartland Hand & Spine Orthopedic Center
  • Orthopaedic Surgical Associates
  • The Orthopedic Center of St. Louis
  • Buffalo Neurosurgery
  • Southern New York NeuroSurgical Group
  • Carolina Neurosurgery and Spine Associates
  • NeuroSpine Institute
  • Neurospine Solutions, PC
  • Milwaukee Spinal Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NuBac

Prodisc-L

Arm Description

NuBac device implanted at the L4/5 level

Prodisc-L implanted at the L4/5 level.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2009
Last Updated
May 14, 2014
Sponsor
Pioneer Surgical Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00931515
Brief Title
Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Official Title
A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pioneer Surgical Technology, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
DDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NuBac
Arm Type
Experimental
Arm Description
NuBac device implanted at the L4/5 level
Arm Title
Prodisc-L
Arm Type
Active Comparator
Arm Description
Prodisc-L implanted at the L4/5 level.
Intervention Type
Device
Intervention Name(s)
NuBac
Other Intervention Name(s)
nucleus replacement, disc arthroplasty
Intervention Description
NuBac device implanted at the L4/5 level.
Intervention Type
Device
Intervention Name(s)
Prodisc-L
Other Intervention Name(s)
Total disc replacement
Intervention Description
Prodisc-L implanted at the L4/5 level.
Primary Outcome Measure Information:
Title
Participants With Improved Patient Function
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Songer, MD
Organizational Affiliation
Orthopedic Surgery Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine Group Beverly Hills
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Tower Orthopedics & Sports Medicine
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Bergey Spine Institute
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Loma Linda University - Faculty Physicians
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of Colorado, Anschutz Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
The Spine Institute
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Florida Orthopaedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Bone & Joint Physicians
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Heartland Hand & Spine Orthopedic Center
City
Merriam
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Orthopaedic Surgical Associates
City
Marquette
State/Province
Michigan
ZIP/Postal Code
49855
Country
United States
Facility Name
The Orthopedic Center of St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Buffalo Neurosurgery
City
Buffalo
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Southern New York NeuroSurgical Group
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Carolina Neurosurgery and Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
NeuroSpine Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Neurospine Solutions, PC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Milwaukee Spinal Specialists
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

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Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

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