Trials / Completed
CompletedNCT01491399
INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate- Pilot Study
Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the CORNERSTONE-SR™Allograft Ring and ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to assess the safety and effectiveness of the Investigational implant as compared to the Control implant in the treatment of patients with one level or two adjacent levels of cervical symptomatic degenerative disc disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ | Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system. |
| DEVICE | Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™ | Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system. |
Timeline
- Start date
- 1999-09-01
- Primary completion
- 2003-03-01
- Completion
- 2003-03-01
- First posted
- 2011-12-14
- Last updated
- 2023-05-17
Source: ClinicalTrials.gov record NCT01491399. Inclusion in this directory is not an endorsement.