Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

Not Applicable

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: NuBac; Device: Prodisc-L

• Registration Number: NCT00931515
• Lead Sponsor: Pioneer Surgical Technology, Inc.

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

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-30
• Study First Posted: 2009-07-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2014-04-15
• Results First Submitted QC: 2014-04-15
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Results First Posted: 2014-05-15
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NuBac	NuBac	NuBac device implanted at the L4/5 level
Prodisc-L	Prodisc-L	Prodisc-L implanted at the L4/5 level.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (17)

Bergey Spine Institute; 🇺🇸 Colton, California, United States

Heartland Hand & Spine Orthopedic Center; 🇺🇸 Merriam, Kansas, United States

Spine Group Beverly Hills; 🇺🇸 Beverly Hills, California, United States

Loma Linda University - Faculty Physicians; 🇺🇸 Loma Linda, California, United States

University of Colorado, Anschutz Outpatient Pavilion; 🇺🇸 Aurora, Colorado, United States

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States

Tower Orthopedics & Sports Medicine; 🇺🇸 Beverly Hills, California, United States

The Spine Institute; 🇺🇸 Loveland, Colorado, United States

Bone & Joint Physicians; 🇺🇸 Oak Lawn, Illinois, United States

Orthopaedic Surgical Associates; 🇺🇸 Marquette, Michigan, United States

The Orthopedic Center of St. Louis; 🇺🇸 St. Louis, Missouri, United States

Buffalo Neurosurgery; 🇺🇸 Buffalo, New York, United States

Southern New York NeuroSurgical Group; 🇺🇸 Johnson City, New York, United States

Neurospine Solutions, PC; 🇺🇸 Bristol, Tennessee, United States

Carolina Neurosurgery and Spine Associates; 🇺🇸 Charlotte, North Carolina, United States

NeuroSpine Institute; 🇺🇸 Eugene, Oregon, United States

Milwaukee Spinal Specialists; 🇺🇸 Milwaukee, Wisconsin, United States