Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two… (NCT00637156) | Clinical Trial Compass
CompletedNot Applicable
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
United States397 participantsStarted 2006-06
Plain-language summary
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment \& involving intractable radiculopathy, myelopathy, or both
* Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies
* Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
* Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)
* Must be ≥ 18 years; skeletally mature at time of surgery
* Preoperative NDI score ≥ 30
* Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire
* If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period
* Is willing to comply with the study plan and sign Patient Informed Consent Form
Exclusion Criteria:
* Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels
* Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiograph…