Trials / Terminated
TerminatedNCT01491477
INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial
Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the Cornerstone-SR™ Allograft Ring and the ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal fusion in patients with 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
- 2002-04-01
- Primary completion
- 2005-04-01
- Completion
- 2005-04-01
- First posted
- 2011-12-14
- Last updated
- 2013-08-02
Source: ClinicalTrials.gov record NCT01491477. Inclusion in this directory is not an endorsement.