Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02667067 · ClinicalTrials.gov registry record · NA
Investigation of the Simplify® Cervical Artificial Disc
A NA study of Cervical Degenerative Disc Disease, sponsored by NuVasive.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 16
- Study locations
NCT02667067: Completed NA study of Cervical Degenerative Disc Disease, sponsored by NuVasive.
NCT02667067 is a NA study of Cervical Degenerative Disc Disease that has completed, run by NuVasive. The registered enrollment target is 150 participants, below the 257-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (42% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02667067, a NA study of Cervical Degenerative Disc Disease, has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months. Individual success for the control ADCF device subjects is defined
Conditions Studied
Interventions
- DEVICE Anterior Cervical Discectomy & Fusion
- DEVICE Simplify Disc
Study Locations (16)
California
- - La Jolla
- - Orange
- - Santa Monica
Texas
- - Addison
- - Plano
- - Tyler
Colorado
- - Thornton
Florida
- - Sarasota
Illinois
- - Evanston
Indiana
- - Carmel
Kentucky
- - Paducah
Louisiana
- - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2015-11 |
| Est. Completion | 2021-07-29 |
| Phase | NA |
What the finished NCT02667067 record still lists
NCT02667067 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 257-participant average among 4 other Cervical Degenerative Disc Disease trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Cervical Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Anterior Cervical Discectomy & Fusion is the first listed.
NCT02667067 lists 16 locations in 12 states (California, Texas, Colorado).
Frequently Asked Questions
What is clinical trial NCT02667067 about?
NCT02667067 is a clinical study titled "Investigation of the Simplify® Cervical Artificial Disc". 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...
What is the current status of trial NCT02667067?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2015-11. Estimated completion is 2021-07-29.
What conditions does trial NCT02667067 study?
This clinical trial studies the following conditions: Cervical Degenerative Disc Disease.
What interventions are being tested in trial NCT02667067?
The interventions under investigation include: Anterior Cervical Discectomy & Fusion (DEVICE), Simplify Disc (DEVICE).
Who is sponsoring clinical trial NCT02667067?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02667067 being conducted?
This trial has 16 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cervical Degenerative Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
The Synergy Disc To Anterior Cervical Discectomy and Fusion
ACTIVE NOT RECRUITING · NA
-
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
ACTIVE NOT RECRUITING · NA
-
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
COMPLETED · NA
-
M6-C Post Approval Study (PAS)
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia