PRESTIGE® Cervical Disc Study (NCT00642876) | Clinical Trial Compass
CompletedNot Applicable
PRESTIGE® Cervical Disc Study
United States541 participantsStarted 2002-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Cervical degenerative disc disease defined as:
✓. 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
✕. 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 \> 20.
✕. More than one cervical level requiring surgical treatment;
What they're measuring
1
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