Investigation of the PRESTIGE® Cervical Disc Device at a Single Level for Symptomatic Cervical Disc Disease

Medtronic Spinal and Biologics31 sites in 1 country541 target enrollmentOctober 2002

ConditionsDegenerative Cervical Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Cervical Disc Disease
Sponsor: Medtronic Spinal and Biologics
Enrollment: 541
Locations: 31
Primary Endpoint: The primary endpoint is overall success, which consists of NDI score, neuro status success, with/without FSU disc ht success, no serious AE classified as "implant/surgical procedure associated", and no secondary surgical procedure classified as failure
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical investigation is to evaluate the safety and effectiveness of the ACD in the single level surgical treatment of patients with symptomatic cervical degenerative disc disease. The primary follow-up information obtained from this clinical investigation are used to support a PMA application for the ACD.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

May 2013

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All patients participating in this study must meet all of the following inclusion criteria:
•Cervical degenerative 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 patient history (e.g., neck and/or arm pain\], functional deficit, and/or neurological deficit, and radiographic studies (e.g., CT, MRI, x-rays, etc).
•herniated disc;
•osteophyte formation;
•One cervical level requiring surgical treatment;
•C3-C4 disc to C6-C7 disc level of involvement;
•Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management;
•No previous surgical intervention at the involved level or any subsequent, planned/staged surgical procedure at the involved or adjacent level(s);
•Is at least 18 years of age, inclusive, at the time of surgery;

Exclusion Criteria

•A patient meeting any of the following criteria is to be excluded from the study:
•Has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level;
•Documented or diagnosed cervical instability defined by dynamic (flexion/extension) radiographs showing:
•Sagittal plane translation \> 3.5 mm or;
•Sagittal plane angulation \>
•More than one cervical level requiring surgical treatment;
•Has a fused level adjacent to the level to be treated;
•Has severe pathology of the facet joints of the involved vertebral bodies;
•Previous surgical intervention at the involved level;
•Has been previously diagnosed with osteopenia or osteomalacia;

Outcomes

Primary Outcomes

The primary endpoint is overall success, which consists of NDI score, neuro status success, with/without FSU disc ht success, no serious AE classified as "implant/surgical procedure associated", and no secondary surgical procedure classified as failure

Time Frame: 24 months

Secondary Outcomes

The secondary outcomes are radiographic success, medical outcomes SF-36 patient survey (MCS & PCS) success, neck pain status, arm pain status, patient satisfaction, patient global perceived effect, gait assessment, foraminal compression test(24 months)