Degenerative Disc DiseaseNCT00931515
Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
A study testing NuBac and Prodisc-L in people with Degenerative Disc Disease, run by Pioneer Surgical Technology, Inc. at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- NuBac and Prodisc-L
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 17 sitesUnited States
- Study dates
- Feb 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Colorado, Anschutz Outpatient Pavilion
Aurora, Colorado, 80045
Spine Group Beverly Hills
Beverly Hills, California, 90211
Tower Orthopedics & Sports Medicine
Beverly Hills, California, 90211
Neurospine Solutions, PC
Bristol, Tennessee, 37620
Buffalo Neurosurgery
Buffalo, New York, 14224
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204
Bergey Spine Institute
Colton, California, 92324
NeuroSpine Institute
Eugene, Oregon, 97401
Southern New York NeuroSurgical Group
Johnson City, New York, 13790
Loma Linda University - Faculty Physicians
Loma Linda, California, 92354
The Spine Institute
Loveland, Colorado, 80538
Orthopaedic Surgical Associates
Marquette, Michigan, 49855
Heartland Hand & Spine Orthopedic Center
Merriam, Kansas, 66204
Milwaukee Spinal Specialists
Milwaukee, Wisconsin, 53211
Bone & Joint Physicians
Oak Lawn, Illinois, 60453
The Orthopedic Center of St. Louis
St Louis, Missouri, 63017
Florida Orthopaedic Institute
Tampa, Florida, 33637
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Degenerative Disc Disease
- Being tested
- NuBac, Prodisc-L
- Keywords
- DDD
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuBacDevice
Also called nucleus replacement, disc arthroplasty
NuBac device implanted at the L4/5 level.
Prodisc-LDevice
Also called Total disc replacement
Prodisc-L implanted at the L4/5 level.
| Study group | Role | What they receive |
|---|---|---|
| NuBac | Experimental | NuBac device implanted at the L4/5 level Receives: Device: NuBac |
| Prodisc-L | Active comparator | Prodisc-L implanted at the L4/5 level. Receives: Device: Prodisc-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pioneer Surgical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Songer, MD, Principal investigator, Orthopedic Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931515
- Sponsor's protocol ID
- N012009
- Status last verified
- May 2014
- First submitted
- 29 Jun 2009
- Last updated
- 26 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
- ClinicalTrials.gov ID
- NCT00931515
- Acronym / sponsor ID
- N012009
- Conditions
- Degenerative Disc Disease
- Keywords
- DDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pioneer Surgical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 15 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuBac | Experimental | Device: NuBacNuBac device implanted at the L4/5 level |
| Prodisc-L | Active comparator | Device: Prodisc-LProdisc-L implanted at the L4/5 level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuBacAlso: nucleus replacement, disc arthroplastyNuBac device implanted at the L4/5 level. | Device | NuBac |
| Prodisc-LAlso: Total disc replacementProdisc-L implanted at the L4/5 level. | Device | Prodisc-L |
Primary outcome
Participants With Improved Patient Function
Time frame: 24 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Songer, MD principal investigator
Orthopedic Surgery Associates
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuBac and Prodisc-L in people with Degenerative Disc Disease, run by Pioneer Surgical Technology, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Improved Patient Function (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.