INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate- Pilot Study
This study has been completed.
Medtronic Spinal and Biologics
First Posted: December 14, 2011
Last Update Posted: August 2, 2013
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
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.
|Degenerative Cervical Disc Disease||Device: INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ Device: Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Medtronic Spinal and Biologics:
Primary Outcome Measures:
- Fusion [ Time Frame: 24 month ]
Fusion is defined as:
- No evidence of motion as defined by: less than 4° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs.
- No radiolucency greater than 2mm of thickness covering more than 50% of superior or inferior graft surface.
- Evidence of bridging trabecular bone.
- Pain/Disability Status [ Time Frame: 24 month ]The self-administered Neck Disability Index will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score >= 15
- Neurological Status [ Time Frame: 24 month ]Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
Secondary Outcome Measures:
- Time to fusion [ Time Frame: 24 month ]
- Hip (Donor Site) Pain [ Time Frame: 24 month ]
- General Health Status (SF-36) [ Time Frame: 24 month ]
- Pain Status (neck pain, arm pain) [ Time Frame: 24 month ]
- Patient Satisfaction [ Time Frame: 24 month ]
- Patient Global Perceived Effect [ Time Frame: 24 month ]
|Study Start Date:||September 1999|
|Study Completion Date:||March 2003|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
|Experimental: INFUSE™ Bone Graft/CORNERSTONE-SR™||
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.
|Active Comparator: Autogenous bone/CORNERSTONE-SR™||
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.
Other Name: Autograft
Contacts and Locations
No Contacts or Locations Provided