By InvitationNot Applicable

Cervical Interbody Implant Study

United States150 participantsStarted 2020-07-07

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Complications of Interbody Implants

Timeframe: 24 months

Radiographic Fusion Success

Timeframe: 24 months

Trial details

NCT IDNCT04689854

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Degenerative Disc Disease trials