This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. The information obtained from this clinical investigation will be used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™ Cervical Disc implanted at two contiguous levels.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels.
Todd H. Lanman, M.D., INC.
Beverly Hills, California, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Kellogg M.D., Brain & Spine
Portland, Oregon, United States
Lexington Brain and Spine
West Columbia, South Carolina, United States
Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
The concentrations of Titanium, Vanadium, and Aluminum at different time points will be summarized using mean and standard deviation. One participant did not receive metal concentration analysis at baseline, therefore the baseline number of participants for these measures N = 24.
Time frame: Preoperative, 6 weeks, and 12 months
Number of Participants Who Achieved Overall Success
The patients enrolled in the study who receive the PRESTIGE LP™ Cervical Disc at two contiguous levels will be considered an overall success if the following criteria are met: 1. NDI score improvement of at least 15 points from baseline; 2. Maintenance or improvement in neurological status; 3. No serious AE classified as implant associated/related or implant/surgical procedure associated/related; 4. No secondary surgical procedure classified as a "failure".
Time frame: 3, 6, and 12 months
Number of Participants Who Achieved NDI Success
The self-administered Neck Disability Index (NDI) Questionnaire will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \> 15
Time frame: 3, 6, and 12 months
Neck Pain and Arm Pain
Numerical rating scales adapted in part from Measuring Health (McDowell and Newell, 1996) will be used to evaluate neck pain and arm pain. Intensity of pain is ranked from 0-10 with 0 being no pain and 10 being pain as bad as it could be; duration of pain is ranked from 0-10 with 0 being none of the time and 10 being pain all of the time. The pain score is derived by adding the numerical rating scores from the pain intensity and duration scales. Therefore the total pain is ranked between 0-20 with 0 being no pain, none of the time; and 20 being maximum pain, constantly.
Time frame: Preoperative, 3, 6, and 12 months
Number of Participants Who Achieved Neurological Success
Neurological status is based on motor function, sensory function, and reflexes. Each of the categories is comprised of a number of elements. Postoperative evaluations of each element will be compared to the preoperative evaluations. Success will be defined as maintenance or improvement in each element for the time period evaluated.
Time frame: 3, 6, and 12 months
Number of Participants Who Underwent Secondary Surgery at Index Level
Some AEs or treatment failures may lead to a secondary surgical intervention at an operated index level. All patients undergoing a secondary surgical intervention at any operated index level will be followed.
Time frame: 3, 6, and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.