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

Medtronic Spinal and Biologics0 sites3 target enrollmentApril 2002

ConditionsDegenerative Cervical Disc Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Degenerative Cervical Disc Disease
Sponsor: Medtronic Spinal and Biologics
Enrollment: 3
Primary Endpoint: Overall Success
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2002

End Date

April 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Has preoperative Neck Disability Index score \> 30;
•Has single cervical disc disease level requiring fusion from C2 to C7;
•No previous surgical intervention at the involved fusion level;

Exclusion Criteria

•Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level.
•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.
•Has been previously diagnosed with osteopenia, or osteomalacia.
•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).
•Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
•Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
•Male over the age of
•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.
•Has presence of active malignancy or prior history of malignancy, except for basal cell carcinoma of the skin.

Outcomes

Primary Outcomes

Overall Success

Time Frame: 12 month

A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Neck Disability Index) Improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure".