Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

NCT ID: NCT00931515

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-12-31

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

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NuBac

NuBac device implanted at the L4/5 level

Group Type: EXPERIMENTAL

NuBac

Intervention Type: DEVICE

NuBac device implanted at the L4/5 level.

Prodisc-L

Prodisc-L implanted at the L4/5 level.

Group Type: ACTIVE_COMPARATOR

Prodisc-L

Intervention Type: DEVICE

Prodisc-L implanted at the L4/5 level.

Interventions

NuBac

NuBac device implanted at the L4/5 level.

Intervention Type: DEVICE

Prodisc-L

Prodisc-L implanted at the L4/5 level.

Intervention Type: DEVICE

Other Intervention Names

nucleus replacement; disc arthroplasty; Total disc replacement

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pioneer Surgical Technology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Songer, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Surgery Associates

Locations

Spine Group Beverly Hills

Beverly Hills, California, United States

Tower Orthopedics & Sports Medicine

Beverly Hills, California, United States

Bergey Spine Institute

Colton, California, United States

Loma Linda University - Faculty Physicians

Loma Linda, California, United States

University of Colorado, Anschutz Outpatient Pavilion

Aurora, Colorado, United States

The Spine Institute

Loveland, Colorado, United States

Florida Orthopaedic Institute

Tampa, Florida, United States

Bone & Joint Physicians

Oak Lawn, Illinois, United States

Heartland Hand & Spine Orthopedic Center

Merriam, Kansas, 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

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, United States

NeuroSpine Institute

Eugene, Oregon, United States

Neurospine Solutions, PC

Bristol, Tennessee, United States

Milwaukee Spinal Specialists

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

N012009

Identifier Type: -

Identifier Source: org_study_id