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INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial | Clinical Trials | Clareo Health

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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

NCT01491477•Medtronic Spinal and Biologics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:
•* herniated disc;
•* osteophyte formation;
•* decreased disc height;
•* thickening of ligamentous tissue;
•* disc degeneration; and/or
•* facet joint degeneration.
•2. Has preoperative Neck Disability Index score \> 30;
•3. Has single cervical disc disease level requiring fusion from C2 to C7;
•4. No previous surgical intervention at the involved fusion level;
+4 more criteria

Exclusion Criteria

•1. Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level.
•2. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged non-steroidal anti-inflammatory drugs excluding routine perioperative anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
•3. Has been previously diagnosed with osteopenia, or osteomalacia.
•4. Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility).
•1. Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
•2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
•3. Male over the age of 70.
•4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.
•If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, the patient is excluded from the study.
•5. Has presence of active malignancy or prior history of malignancy, except for basal cell carcinoma of the skin.
+11 more criteria

Key Dates

Start Date

April 1, 2002

Primary Completion Date

April 1, 2005

Completion Date

April 1, 2005

Last Updated

August 2, 2013

Enrollment

ACTUAL participants

Conditions

Degenerative Cervical Disc Disease

Interventions

INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™

DEVICE

Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™

DEVICE

Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®

NCT06876311

Degenerative Cervical Disc DiseaseDegenerative Lumbar Diseases

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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