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 range

18 Years

Sex

ALL

See this in plain English?

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) 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite Clinical Success (CCS) Rate of the Simplify® Disc

Timeframe: 24 Months

Trial details

NCT IDNCT03123549

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-12

Results submitted2022-10-13

View on ClinicalTrials.gov More Cervical Degenerative Disc Disorder trials