Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

NCT00931515 | Completed Results DMC

• 1 other identifier: N012009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 17

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.

Conditions

Degenerative Disc Disease

Keywords

DDD

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Study Arms (2)

NuBac

EXPERIMENTAL

NuBac device implanted at the L4/5 level

Device: NuBac

Prodisc-L

ACTIVE COMPARATOR

Prodisc-L implanted at the L4/5 level.

Device: Prodisc-L

Interventions

NuBac DEVICE

NuBac device implanted at the L4/5 level.

Also known as: nucleus replacement, disc arthroplasty

NuBac

Prodisc-L DEVICE

Prodisc-L implanted at the L4/5 level.

Also known as: Total disc replacement

Prodisc-L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pioneer Surgical Technology, Inc.: lead

Study Sites (17)

Spine Group Beverly Hills

Beverly Hills, California, 90211, United States

Location

Tower Orthopedics & Sports Medicine

Beverly Hills, California, 90211, United States

Location

Bergey Spine Institute

Colton, California, 92324, United States

Location

Loma Linda University - Faculty Physicians

Loma Linda, California, 92354, United States

Location

University of Colorado, Anschutz Outpatient Pavilion

Aurora, Colorado, 80045, United States

Location

The Spine Institute

Loveland, Colorado, 80538, United States

Location

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Location

Bone & Joint Physicians

Oak Lawn, Illinois, 60453, United States

Location

Heartland Hand & Spine Orthopedic Center

Merriam, Kansas, 66204, United States

Location

Orthopaedic Surgical Associates

Marquette, Michigan, 49855, United States

Location

The Orthopedic Center of St. Louis

St Louis, Missouri, 63017, United States

Location

Buffalo Neurosurgery

Buffalo, New York, 14224, United States

Location

Southern New York NeuroSurgical Group

Johnson City, New York, 13790, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204, United States

Location

NeuroSpine Institute

Eugene, Oregon, 97401, United States

Location

Neurospine Solutions, PC

Bristol, Tennessee, 37620, United States

Location

Milwaukee Spinal Specialists

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Total Disc Replacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

Because the study was stopped after a total of 30 patients, demonstration of non-inferiority was impossible. Results from the 2 groups were compared using the Fisher exact test for categorical variables and ANOVA for continuous variables.

Results Point of Contact

• Title: Director of Regulatory and Clinical Affairs
• Organization: Pioneer Surgical Technology

emilydowns@pioneersurgical.com

906-225-5602

Study Officials

• Matthew Songer, MD

  Orthopedic Surgery Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: July 2, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 26, 2014
• Results First Posted: May 15, 2014

Record last verified: 2014-05

Locations

US (17)