At a glance
ClinicalIndex Comparison Record- ✓Age 18-60 years
- ✓Single-level cervical DDD (C3-C7) with radiculopathy ± neck pain or myelopathy
- ✓Radiographic evidence of spondylosis, disc height loss ≥1 mm vs adjacent levels, or disc herniation
- ✓At least one radiculopathy or myelopathy symptom: pain/paresthesias in nerve root distribution, decreased muscle strength (≥1 level), or abnormal sensation
- ✕Marked cervical instability: translation >3 mm or rotation >11° on flexion/extension X-ray
- ✕Non-discogenic neck pain or symptoms (tumor, rotator cuff injury, etc.)
- ✕Severe facet disease or bridging osteophytes
- ✕<2° motion at index level
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study Protocol for the Investigation Of The Simplify® Cervical Artificial Disc
In Brief
A clinical study evaluating Simplify Disc and Anterior Cervical Discectomy & Fusion for Cervical Degenerative Disc Disease. Completed, enrolled 150 participants across 16 sites.
Detailed 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.
Study Details
Timeline
Interventions
Simplify Disc at one level in the cervical spine.
This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\|C Disc trial.