Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease

Medtronic Spinal and Biologics37 sites in 1 country494 target enrollmentJune 2003

ConditionsRadiculopathy Myelopathy Cervical Degenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Radiculopathy
Sponsor: Medtronic Spinal and Biologics
Enrollment: 494
Locations: 37
Primary Endpoint: Improvement in patient pain and ability to function
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.

Detailed Description

Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

May 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.
•The following additional inclusion criteria had to be present:
•At least 6 weeks unsuccessful conservative treatment, except in cases of myelopathy requiring immediate treatment (e.g., acute onset of clinically significant signs);
•Requirement for surgical treatment demonstrated by CT, myelography and CT, and/or MRI;
•Skeletally mature (≥ 21 years of age);
•Preoperative Neck Disability Index score of ≥ 30 and at least one clinical sign associated with level to be treated;
•Willing to sign informed consent and comply with protocol.

Exclusion Criteria

•Subjects were excluded if they had any of the following:
•Any of the following at the treated level:
•Significant cervical anatomical deformity; e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
•Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes. Such advanced changes are characterized by any one or combination of the following: bridging osteophytes, marked reduction or absence of motion, collapse of the intervertebral disc space of greater than 50% of its normal height;
•Radiographic signs of subluxation greater than 3.5 mm;
•Angulation of the disc space more than 11 degrees greater than adjacent segments;
•Significant kyphotic deformity or significant reversal of lordosis;
•Axial neck pain as the solitary symptom;
•Previous cervical spine surgery;
•Metabolic bone disease, such as osteoporosis, defined as a BMD T-score equal to or worse than 2.

Outcomes

Primary Outcomes

Improvement in patient pain and ability to function

Time Frame: 24 months

The self-administered Neck Disability Index patient questionnaire is used to assess patient pain and ability to function. A successful outcome will be declared if: Postoperative Score - Postoperative Score is ≥ 15.