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| Sponsor: | Pioneer Surgical Technology, Inc. |
|---|---|
| Information provided by: | Pioneer Surgical Technology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00931515 |
Purpose
The NuBac device is indicated for reconstruction following nucleectomy 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.
| Condition | Intervention |
|---|---|
|
Degenerative Disc Disease |
Device: NUBAC™ |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty |
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
STUDY DESIGN:
Multi-center, 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jon Gilbert | (906) 226-9909 | jongilbert@pioneersurgical.com |
| United States, California | |
| Spine Group Beverly Hills | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact: Liz Homsher 310-385-8010 | |
| Principal Investigator: John J Regan, MD | |
| Sub-Investigator: Todd Lanman, MD | |
| Tower Orthopedics & Sports Medicine | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact: Lacey Feldman, CRC 310-855-0751 ext 2109 lacey.feldman@olympiamc.com | |
| Principal Investigator: Carl Lauryssen, MD | |
| The Cedars Sinai Institute for Spinal Disorders | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Principal Investigator: Neel Anand, MD | |
| The Cedars Sinai Institute for Spinal Disorders | Recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Helen Cambron 310-423-9709 cambronh@cshs.org | |
| Sub-Investigator: Patrick Johnson, MD | |
| United States, Colorado | |
| The Spine Institute | Recruiting |
| Loveland, Colorado, United States, 80538 | |
| Contact: Nicole Rittenhouse, MA, CCRC 970-669-8881 ext 229 nrittenhouse@spinerevolution.com | |
| Contact: Kenneth Pettine, MD kpettine@spinerevolution.com | |
| Principal Investigator: Kenneth A Pettine, MD | |
| Sub-Investigator: W. Carlton Reckling, MD | |
| United States, Florida | |
| Florida Spine Institute | Recruiting |
| Clearwater, Florida, United States, 33765 | |
| Florida Orthopaedic Institute | Recruiting |
| Tampa, Florida, United States, 33607 | |
| United States, Illinois | |
| Bone & Joint Physicians | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Principal Investigator: George Miz, MD | |
| United States, Kansas | |
| Heartland Hand & Spine Orthopedic Center | Recruiting |
| Overland Park, Kansas, United States, 66211 | |
| Contact: Cindy Barrack 913-649-7300 | |
| Principal Investigator: William Reed, MD | |
| Sub-Investigator: Alexander Bailey, MD | |
| Sub-Investigator: Glenn Amundson, MD | |
| United States, Michigan | |
| Orthopaedic Surgical Associates | Recruiting |
| Marquette, Michigan, United States, 49855 | |
| United States, Missouri | |
| The Orthopedic Center of St. Louis | Recruiting |
| St. Louis, Missouri, United States, 63017 | |
| Contact: Francine Schranck 314-392-5089 | |
| Principal Investigator: Matthew Gornet, MD | |
| Sub-Investigator: Brett Taylor, MD | |
| United States, New York | |
| Buffalo Neurosurgery | Recruiting |
| Buffalo, New York, United States, 14224 | |
| Contact: Robin Venditti 716-677-6000 | |
| Principal Investigator: Jeffrey Lewis, MD | |
| Sub-Investigator: Douglas Moreland, MD | |
| Southern New York NeuroSurgical Group | Recruiting |
| Johnson City, New York, United States, 13790 | |
| Contact: Research Coordinator 607-798-0718 | |
| Principal Investigator: Saeed Bajwa, MD | |
| Sub-Investigator: Khalid Sethi, MD | |
| United States, North Carolina | |
| Carolina Neurosurgery and Spine Associates | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Oregon | |
| NeuroSpine Institute | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| United States, Texas | |
| Brain & Spine Center of Texas | Recruiting |
| Plano, Texas, United States, 75093 | |
| Principal Investigator: Joseph Stachniak, MD | |
| United States, Wisconsin | |
| Milwaukee Spinal Specialists | Recruiting |
| Milwaukee, Wisconsin, United States, 53211 | |
| Contact: Marty Naber, PA 414-961-2225 | |
| Principal Investigator: Stephen Robbins, MD | |
More Information
| Responsible Party: | Pioneer Surgical Technology, Inc. ( Jonathan Gilbert / VP Regulatory/Clinical Affairs ) |
| ClinicalTrials.gov Identifier: | NCT00931515 History of Changes |
| Other Study ID Numbers: | N012009 |
| Study First Received: | June 29, 2009 |
| Last Updated: | February 15, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
DDD |