Investigation of the Two Level Simplify® Cervical Artificial Disc (NCT03123549) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Two Level Simplify® Cervical Artificial Disc
United States182 participantsStarted 2017-04-01
Plain-language summary
This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify® Disc) is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 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 pain with 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 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 at least 18 years of age and be skeletally mature at the time of surgery;
* Has a preoperative Neck Disability Index (NDI) ≥ 30;
* Has a 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 the Patient Informed Consent Form.
Exclusion Criteria:
* Has a cervical spinal condition other than sympto…
What they're measuring
1
Composite Clinical Success (CCS) Rate of the Simplify® Disc