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NCT00485173 · ClinicalTrials.gov registry record · NA
INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial
A NA study of Degenerative Disc Disease, sponsored by Medtronic Spinal and Biologics.
- Completed
- Registry status
- NA
- Development phase
- 224
- Enrollment target
- 16
- Study locations
NCT00485173: Completed NA study of Degenerative Disc Disease, sponsored by Medtronic Spinal and Biologics.
NCT00485173 is a NA study of Degenerative Disc Disease that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 224 participants, above the 163-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (37% higher). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00485173, a NA study of Degenerative Disc Disease, has completed, sponsored by Medtronic Spinal and Biologics.
- COMPLETED
- Registry status
- NA
- Development phase
- 224 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.
Primary Outcome
Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. fusion at the treated level; 2. pain/disability (Neck Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;" 5. no additional surgical procedure classified as a "failure."
Conditions Studied
Interventions
- DEVICE INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
Study Locations (16)
California
- S & B Surgery Center - Beverly Hills
- Orange County Neurological Association - Laguna Hills
Ohio
- University of Cincinnati Dept of Neurosurgery - Cincinnati
- TriState Orthopedic Treatment Center - Norwood
Tennessee
- Center for Sports Medcine & Orthopedics - Chattanooga
- Semmes Murphey Neurologic & Spine Institute - Memphis
Texas
- Central Texas Spine - Austin
- Brain and Spine Center of Texas, L.L.P. - Plano
Florida
- Crane Creek Medical Ctr. The Back Center /Osler Medical - Melbourne
Georgia
- The Hughston Clinic, P.C. - Columbus
Kansas
- University of Kansas Medcal Center - Kansas City
Louisiana
- Spine Institute - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2007-06 |
| Est. Completion | 2012-06 |
| Phase | NA |
What the finished NCT00485173 record still lists
NCT00485173 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, above the 163-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (37% higher).
The record links to 1 condition, with Degenerative Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate is the first listed.
NCT00485173 lists 16 locations in 12 states (California, Ohio, Tennessee).
Frequently Asked Questions
What is clinical trial NCT00485173 about?
NCT00485173 is a clinical study titled "INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial". The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disea...
What is the current status of trial NCT00485173?
This trial is currently completed. It is a NA study. The enrollment target is 224 participants. The study started on 2007-06. Estimated completion is 2012-06.
What conditions does trial NCT00485173 study?
This clinical trial studies the following conditions: Degenerative Disc Disease.
What interventions are being tested in trial NCT00485173?
The interventions under investigation include: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate (DEVICE).
Who is sponsoring clinical trial NCT00485173?
This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00485173 being conducted?
This trial has 16 study locations across California, Florida, Georgia, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Degenerative Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00485173's enrollment target sits among peer trials
224 11th of 42 higher than 32 of 42 other Degenerative Disc Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Degenerative Disc Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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