Investigation of the Two Level Simplify® Cervical Artificial Disc

Completed · Not applicable

Conditions studied: Cervical Degenerative Disc Disorder

In brief

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.

Key facts

Study ID

NCT03123549

Run by

NuVasive

People needed

182

Starts

2017-04-01

Expected to finish

2022-03-24

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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) radiographs showing:
• Sagittal plane translation > 3.5 mm, or
• Sagittal plane angulation > 20°;
• Has more than two cervical levels requiring surgical treatment;
• Has a fused level (or artificial disc replacement) adjacent to the levels to be treated;
• 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 or at adjacent levels;
• Axial neck pain only (no radicular or myelopathy symptoms);
• Has been previously diagnosed with osteopenia or osteomalacia;
• Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility):
• Postmenopausal non-black female over 60 years of age who weighs less than 140 pounds;
• Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture;
• Male over the age of 70;
• Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.
• If the level of bone mineral density is a T score of -1.5 or lower (i.e., -1.6, 1.7, etc.), then the patient is excluded from the study
• Has presence of spinal metastases;
• Has overt or active bacterial infection, either local or systemic;
• Has insulin-dependent diabetes;
• Has chronic or acute renal failure or prior history of renal disease;
• Known PEEK, ceramic, titanium allergy;
• Is mentally incompetent (if questionable, obtain psychiatric consult);
• Is a prisoner;
• Is pregnant;
• Is currently an alcohol and/or drug abuser or currently undergoing treatment for alcohol and/or drug abuse;

Where it is running

• Orthopaedic Education and Research Institute of Southern California — Orange, California, United States
• The Spine Institute for Spine Restoration — Santa Monica, California, United States
• Spine Education and Research Foundation — Thornton, Colorado, United States
• Connecticut Orthopaedic Specialists — Hamden, Connecticut, United States
• Kennedy-White orthopedic Center — Sarasota, Florida, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States
• Spine institute of Louisiana — Shreveport, Louisiana, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Buffalo Spine Surgery — Lockport, New York, United States
• Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
• Oregon Neurosurgery — Springfield, Oregon, United States
• Texas Spine Consultants — Addison, Texas, United States
• Texas Back Institute — Plano, Texas, United States
• The Disc Replacement Center — West Jordan, Utah, United States
• Virginia Spine Institute — Reston, Virginia, United States

Full record on ClinicalTrials.gov

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