CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
Recruiting
N/A
Interventional Study
Neck Pain
Spondylosis
Spondylosis With Myelopathy
Spondylosis With Radiculopathy
Spondylosis With Radiculopathy Cervical Region
Intervertebral Disc Disorder Cervical
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 – 79
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- ReVivo Medical, Corp. · Industry
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About This Trial
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 month…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Males and females aged 22-79 years.
2. Documented diagnosis of cervical spine radiculopathy or myelopathy.
3. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
4. Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
5. Pathology at…
Contacts