Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
AO Clinical Investigation and Documentation CeraPedics, Inc |
---|---|
Information provided by: | AO Clinical Investigation and Documentation |
ClinicalTrials.gov Identifier: | NCT00310440 |
The aim of this trial is to evaluate if P-15 bone putty is not inferior in effectiveness and safety to DBX when applied in instrumented anterior cervical discectomy and fusion with use of a structural allograft ring in patients with degenerative cervical disc disease.
Condition | Intervention | Phase |
---|---|---|
Degenerative Disc Disease (DDD) Decompresion of Spine Root |
Device: Synthetic osteoconductive bone substitute |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation |
Estimated Enrollment: | 204 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
Spine Education Research Institute | Recruiting |
Thornton, Colorado, United States, 80228 | |
Contact: Michael Janssen, MD, DO 720-540-7374 janssenm@spine-education.org | |
Principal Investigator: Michael Janssen, MD, DO |
Principal Investigator: | Michael Janssen, MD / DO | Spine Education Research Institute |
Responsible Party: | CeraPedics, Inc. ( Andy Handwerker ) |
Study ID Numbers: | 06-P15-04 |
Study First Received: | April 3, 2006 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00310440 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Degenerative disc disease P-15 Bone Putty Bone replacement material |
Cervical discectomy Loss of foraminal area neural compression |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |