Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pioneer Surgical Technology, Inc.

ClinicalTrials.gov Identifier:

NCT00931515

First received: June 29, 2009

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 29, 2009
Last Updated Date	April 8, 2013
Start Date ^ICMJE	February 2009
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2009)	Improved patient function [ Time Frame: 6 weeks, 3, 6, 12, 24 months, annually thereafter ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00931515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Official Title ^ICMJE	A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Degenerative Disc Disease
Intervention ^ICMJE	Device: NuBac NuBac device implanted at the L4/5 level. Other Names: nucleus replacement disc arthroplasty Device: Prodisc-L Prodisc-L implanted at the L4/5 level. Other Name: Total disc replacement
Study Arm (s)	Experimental: NuBac NuBac device implanted at the L4/5 level Intervention: Device: NuBac Active Comparator: Prodisc-L Prodisc-L implanted at the L4/5 level. Intervention: Device: Prodisc-L
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	52
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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, IDET, 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00931515
Other Study ID Numbers ^ICMJE	N012009
Has Data Monitoring Committee	Yes
Responsible Party	Pioneer Surgical Technology, Inc.
Study Sponsor ^ICMJE	Pioneer Surgical Technology, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pioneer Surgical Technology, Inc.
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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