Clinical Trials in the USA / NCT04689854
Enrolling by invitation
Observational
Cervical Interbody Implant Study
NCT04689854 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Degenerative Disc DiseaseCervical Spinal Instability
Study 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 patient-reported outcomes (PROs).
Eligibility
Inclusion Criteria:
1. Patients who are ≥18 years of age at the time of consent
2. 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
3. Using one of the following implants (NuVasive, Inc., San Diego, CA):
1. Cohere Cervical
2. Modulus Cervical
4. 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
5. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
6. 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 Criteria:
1. Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
1. Bone morphogenic protein (BMP) (i.e., Infuse (Medtronic))
2. 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))
3. 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))
4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
2. Previous cervical fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
3. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
4. Use of bone growth stimulators postoperatively
5. Active smoking within 6 weeks before surgery
6. Patient has known sensitivity to the materials implanted
7. Systemic or local infection (latent or active) or signs of local inflammation
8. Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
9. Patient is a prisoner
10. Patient is participating in another clinical study that would confound study data
Primary outcome measure(s)
- Complications of Interbody Implants — 24 months
Rate of complications (i.e., safety) attributable to the use of the interbody implants to be studied. - Radiographic Fusion Success — 24 months
The proportion of subjects with apparent radiographic fusion (i.e., performance) of the index surgical level(s) at 24 months postoperative.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Orthopedic Specialty Institute | Orange | California | |
| Hartford Healthcare Bone and Joint Institute | Hartford | Connecticut | |
| Mass General Brigham | Somerville | Massachusetts | |
| Columbia Orthopedic Group Research | Columbia | Missouri | |
| Duke University | Durham | North Carolina | |
| Summa Health | Akron | Ohio | |
| University of Virginia | Charlottesville | Virginia |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04689854 on ClinicalTrials.gov ↗ ← All trials in the USA