CompletedNot Applicable

Investigation of the Simplify® Cervical Artificial Disc

United States150 participantsStarted 2015-11

Plain-language summary

This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space in subjects who are unresponsive to conservative management.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Spondylosis (defined by the presence of osteophytes or dark disc) on CT or MRI or;
✓. Disc height decreased by ≥ 1 mm when compared to adjacent levels on radiographic film, CT, or MRI or
✓. Disc herniation on CT or MRI;
✓. Pain or paresthesias in a specific nerve root distribution from C3 to C7,
✓. Decreased muscle strength of at least one level on the 0-5 scale, or
✓. Abnormal sensation, including hyperesthesia or hypoesthesia.
✓. At least six weeks of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose);
✓. The presence of progressive symptoms (e.g., increasing numbness or tingling) or

Exclusion criteria

✕. Diabetes mellitus requiring daily insulin management,
✕. Active malignancy,
✕. History of metastatic malignancy.

What they're measuring

Number of Participants With Composite Clinical Success (CCS) of Simplify Disc

Timeframe: Baseline, 24 Months

Trial details

NCT IDNCT02667067

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-23

Results submitted2022-04-04

View on ClinicalTrials.gov More Cervical Degenerative Disc Disease trials