Status:
ENROLLING_BY_INVITATION
Cervical Interbody Implant Study
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease
Cervical Spinal Instability
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patie...
Detailed Description
This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery of the cervical...
Eligibility Criteria
Inclusion
- Patients who are ≥18 years of age at the time of consent
- Have a planned spine surgery using interbody implants at one or more cervical levels (C2-T1) for degenerative disc disease and/or cervical spinal instability
- Using one of the following implants (NuVasive, Inc., San Diego, CA):
- Cohere Cervical
- Modulus Cervical
- With interbody fusion using autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone) and NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the cervical spine
- Able to undergo surgery based on physical exam, medical history, and surgeon judgment
- Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study
Exclusion
- Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
- Bone morphogenic protein (BMP) (i.e., Infuse (Medtronic))
- Synthetic bone graft extenders (e.g., Formagraft (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), and ChronOs (Depuy Synthes))
- Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g., Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis), and Propel Putty/Gel (NuVasive))
- Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
- Previous cervical fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
- Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Use of bone growth stimulators postoperatively
- Active smoking within 6 weeks before surgery
- Patient has known sensitivity to the materials implanted
- Systemic or local infection (latent or active) or signs of local inflammation
- Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
- Patient is a prisoner
- Patient is participating in another clinical study that would confound study data
Key Trial Info
Start Date :
July 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04689854
Start Date
July 7 2020
End Date
December 31 2025
Last Update
December 22 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Orthopedic Specialty Institute
Orange, California, United States, 92868
2
Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, United States, 06106
3
Mass General Brigham
Somerville, Massachusetts, United States, 02145
4
Columbia Orthopedic Group Research
Columbia, Missouri, United States, 65201