Degenerative Disc Disease
Conditions
Keywords
DDD
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
Interventions
DEVICENuBac
NuBac device implanted at the L4/5 level.
DEVICEProdisc-L
Prodisc-L implanted at the L4/5 level.
Sponsors
Pioneer Surgical Technology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Improved Patient Function | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from February 2009 to December 2010. Patients were recruited from the medical practices of the Investigators. Enrollment was stopped in December 2010 due to the slow enrollment rate. A total of 30 subjects participated in the study; the protocol was intended for 440 patients.
Pre-assignment details
Two patients were enrolled in the study and received a patient identification number, but were never randomized to a treatment group and never implanted with the device. One patient decided not to participate prior to randomization. The second patient did not meet all inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| NuBac The NUBAC® disc arthroplasty system. | 15 |
| ProDisc The ProDisc® total disc replacement system. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 5 |
Baseline characteristics
| Characteristic | ProDisc | NuBac | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 14 Participants | 29 Participants |
| Age, Continuous | 40.1 years STANDARD_DEVIATION 11.2 | 44.0 years STANDARD_DEVIATION 11.2 | 42.05 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 15 | 14 / 15 |
| serious Total, serious adverse events | 3 / 15 | 0 / 15 |
Outcome results
Primary
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: 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.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NuBac | Participants With Improved Patient Function | 7 participants |
| ProDisc | Participants With Improved Patient Function | 6 participants |
p-value: 1Fisher Exact