An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical … (NCT03062657) | Clinical Trial Compass
TerminatedNot Applicable
An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LPâ„¢ Cervical Disc at Two Contiguous Levels in the Cervical Spine
Stopped: Study terminated prematurely as agreed by the FDA. The FDA were satisfied that no further data was required, despite the total number of patients who completed the study in full not being the agreed upon number.
United States25 participantsStarted 2018-06-06
Plain-language summary
This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LPâ„¢ 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 LPâ„¢ Cervical Disc implanted at two contiguous levels.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has cervical degenerative disc disease at two (2) contiguous cervical levels (from C3 to C7) requiring surgical treatment and 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 (e.g., neck and/or arm pain, functional deficit and /or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
✓. Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative therapy;
✓. Has no previous surgical intervention at the involved levels or any other planned/staged surgical procedure at the involved levels;
✓. Has preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire;
✓. Must be at least 18 years of age and be skeletally mature at the time of surgery;
✓. If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;
✓
What they're measuring
1
Concentrations of Titanium, Vanadium, and Aluminum in the Blood Serum
. Is willing to comply with the study plan and sign the Patient Informed Consent Form.
Exclusion criteria
✕. Has a cervical spine condition other than symptomatic cervical degenerative disease requiring surgical treatment at the involved levels;
✕. Has documented or diagnosed cervical instability relative to contiguous segments at either level, defined by dynamic (flexion/extension) radiographs showing:
✕. Sagittal plane translation \> 3.5 mm, or
✕. Sagittal plane angulation \> 20°
✕. Has more than two cervical levels requiring surgical treatment;
✕. Has severe pathology of the facet joints of the involved vertebral bodies;
✕. Has had previous surgical intervention at either one or both of the involved levels;
✕. Has been previously diagnosed with osteopenia or osteomalacia;