Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

Degenerative Disc Disease Clinical Trial

Official title:

A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931515
• Other study ID #: N012009
• Status: Completed
• Phase: N/A
• First received: June 29, 2009
• Last updated: May 14, 2014
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Pioneer Surgical Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• NuBac
NuBac device implanted at the L4/5 level.
• Prodisc-L
Prodisc-L implanted at the L4/5 level.

Locations

Country	Name	City	State
United States	University of Colorado, Anschutz Outpatient Pavilion	Aurora	Colorado
United States	Spine Group Beverly Hills	Beverly Hills	California
United States	Tower Orthopedics & Sports Medicine	Beverly Hills	California
United States	Neurospine Solutions, PC	Bristol	Tennessee
United States	Buffalo Neurosurgery	Buffalo	New York
United States	Carolina Neurosurgery and Spine Associates	Charlotte	North Carolina
United States	Bergey Spine Institute	Colton	California
United States	NeuroSpine Institute	Eugene	Oregon
United States	Southern New York NeuroSurgical Group	Johnson City	New York
United States	Loma Linda University - Faculty Physicians	Loma Linda	California
United States	The Spine Institute	Loveland	Colorado
United States	Orthopaedic Surgical Associates	Marquette	Michigan
United States	Heartland Hand & Spine Orthopedic Center	Merriam	Kansas
United States	Milwaukee Spinal Specialists	Milwaukee	Wisconsin
United States	Bone & Joint Physicians	Oak Lawn	Illinois
United States	The Orthopedic Center of St. Louis	St. Louis	Missouri
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pioneer Surgical Technology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: Oswestry Disability Index score improved by at least 15 points; Device success; Neurological success; Absence of major complications; 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	No