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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™ vs ProDisc™ |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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| United States, California | |
| Spine Group Beverly Hills | |
| Beverly Hills, California, United States, 90211 | |
| Tower Orthopedics & Sports Medicine | |
| Beverly Hills, California, United States, 90211 | |
| The Cedars Sinai Institute for Spinal Disorders | |
| Los Angeles, California, United States, 90048 | |
| United States, Colorado | |
| University of Colorado, Anschutz Outpatient Pavilion | |
| Aurora, Colorado, United States, 80045 | |
| The Spine Institute | |
| Loveland, Colorado, United States, 80538 | |
| United States, Florida | |
| Florida Spine Institute | |
| Clearwater, Florida, United States, 33765 | |
| Florida Orthopaedic Institute | |
| Tampa, Florida, United States, 33607 | |
| United States, Illinois | |
| Bone & Joint Physicians | |
| Oak Lawn, Illinois, United States, 60453 | |
| United States, Kansas | |
| Heartland Hand & Spine Orthopedic Center | |
| Overland Park, Kansas, United States, 66211 | |
| United States, Michigan | |
| Orthopaedic Surgical Associates | |
| Marquette, Michigan, United States, 49855 | |
| United States, Missouri | |
| The Orthopedic Center of St. Louis | |
| St. Louis, Missouri, United States, 63017 | |
| United States, New York | |
| Buffalo Neurosurgery | |
| Buffalo, New York, United States, 14224 | |
| Southern New York NeuroSurgical Group | |
| Johnson City, New York, United States, 13790 | |
| United States, North Carolina | |
| Carolina Neurosurgery and Spine Associates | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Oregon | |
| NeuroSpine Institute | |
| Eugene, Oregon, United States, 97401 | |
| United States, Texas | |
| Brain & Spine Center of Texas | |
| Plano, Texas, United States, 75093 | |
| United States, Wisconsin | |
| Milwaukee Spinal Specialists | |
| Milwaukee, Wisconsin, United States, 53211 | |
More Information
| Responsible Party: | Jonathan Gilbert / VP Regulatory/Clinical Affairs, Pioneer Surgical Technology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00931515 History of Changes |
| Other Study ID Numbers: | N012009 |
| Study First Received: | June 29, 2009 |
| Last Updated: | December 28, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
DDD |
|
Intervertebral Disk Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases |