Cervical Interbody Implant Study

NCT ID: NCT04689854

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2025-12-31

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 patient-reported outcomes (PROs).

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 spine. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 patients in each implant group) will be enrolled and will be followed for 24 months after the surgery.

Conditions

Degenerative Disc Disease; Cervical Spinal Instability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohere Cervical

No interventions assigned to this group

Modulus Cervical

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuVasive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Malone, MS

Role: STUDY_DIRECTOR

Globus Medical

Locations

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

Countries

United States

Other Identifiers

NUVA.CIB0420

Identifier Type: -

Identifier Source: org_study_id