Clinical trial NCT00931515: 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
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: DDD
Lead sponsor: Pioneer Surgical Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Participants With Improved Patient Function
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Spine Group Beverly Hills
state: California
city: Beverly Hills
country: United States
facility: Tower Orthopedics & Sports Medicine
state: California
city: Colton
country: United States
facility: Bergey Spine Institute
state: California
city: Loma Linda
country: United States
facility: Loma Linda University - Faculty Physicians
state: California
city: Aurora
country: United States
facility: University of Colorado, Anschutz Outpatient Pavilion
state: Colorado
city: Loveland
country: United States
facility: The Spine Institute
state: Colorado
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Oak Lawn
country: United States
facility: Bone & Joint Physicians
state: Illinois
city: Merriam
country: United States
facility: Heartland Hand & Spine Orthopedic Center
state: Kansas
city: Marquette
country: United States
facility: Orthopaedic Surgical Associates
state: Michigan
city: St. Louis
country: United States
facility: The Orthopedic Center of St. Louis
state: Missouri
city: Buffalo
country: United States
facility: Buffalo Neurosurgery
state: New York
city: Johnson City
country: United States
facility: Southern New York NeuroSurgical Group
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates
state: North Carolina
city: Eugene
country: United States
facility: NeuroSpine Institute
state: Oregon
city: Bristol
country: United States
facility: Neurospine Solutions, PC
state: Tennessee
city: Milwaukee
country: United States
facility: Milwaukee Spinal Specialists
state: Wisconsin
Study officials:
affiliation: Orthopedic Surgery Associates
name: Matthew Songer, MD
role: PRINCIPAL_INVESTIGATOR
References: