Cervical Interbody Implant Study
Enrolling by invitation
Conditions studied: Degenerative Disc Disease, Cervical Spinal Instability
In brief
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 patient-reported outcomes (PROs).
Key facts
- Study ID
- NCT04689854
- Run by
- NuVasive
- People needed
- 150
- Starts
- 2020-07-07
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Orthopedic Specialty Institute — Orange, California, United States
- Hartford Healthcare Bone and Joint Institute — Hartford, Connecticut, United States
- Mass General Brigham — Somerville, Massachusetts, United States
- Columbia Orthopedic Group Research — Columbia, Missouri, United States
- Duke University — Durham, North Carolina, United States
- Summa Health — Akron, Ohio, United States
- University of Virginia — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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