Lumbar Interbody Implant Study

NCT ID: NCT04418830

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1050 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2026-07-01

Brief Summary

The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and patient-reported outcomes. This study is being undertaken to identify possible residual risks and to clarify mid- to long-term clinical performance that may affect the benefit/risk ratios of these interbody implants.

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. 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 thoracic and/or lumbar 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 1050 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; Degenerative Spondylolisthesis; Degenerative Scoliosis; Spinal Stenosis; Sagittal Deformity

Keywords

Spine Surgery; Medical Device

Study Design

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

Study Groups

Base Interfixated System

No interventions assigned to this group

Brigade Interfixated System

No interventions assigned to this group

Coalesce Thoracolumbar Interbody

No interventions assigned to this group

Cohere XLIF Interbody System

No interventions assigned to this group

CoRoent Ti PLIF Interbody System

No interventions assigned to this group

CoRoent Ti TLIF Interbody System

No interventions assigned to this group

MLX - Medial Lateral Expandable Interbody System

No interventions assigned to this group

Modulus TLIF Interbody System

No interventions assigned to this group

Modulus XLIF Interbody System

No interventions assigned to this group

TLX Interbody System

No interventions assigned to this group

XLX ACR Interbody System

No interventions assigned to this group

CoRoent Ti XLIF Interbody System

No interventions assigned to this group

Cohere TLIF

No interventions assigned to this group

Modulus ALIF

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients who are ≥18 years of age at the time of consent

2. Planned spine surgery using interbody implants at:

1. One or two adjacent thoracic, lumbar, and/or lumbosacral levels for degenerative disc disease or degenerative spondylolisthesis, or

2. One or two adjacent thoracic, lumbar, and/or lumbosacral levels for spinal stenosis (not applicable for MLX, TLX, or XLX ACR), or

3. Any number of thoracic, lumbar, and/or lumbosacral levels for degenerative scoliosis (defined as >10º coronal curve), or

4. Any number of thoracic, lumbar, and/or lumbosacral levels for sagittal deformity (not applicable for MLX, TLX, or XLX ACR).

3. Use of one of the following implants (NuVasive, Inc., San Diego, CA):

1. Base Interfixated

2. Brigade Interfixated

3. Coalesce Thoracolumbar

4. Cohere TLIF

5. Cohere XLIF

6. Coroent Ti PLIF

7. Coroent Ti TLIF

8. Coroent Ti XLIF

9. MLX

10. Modulus ALIF

11. Modulus TLIF

12. Modulus XLIF

13. TLX

14. XLX ACR

4. Interbody fusion with one or more of the following (as allowed by implant type):

1. autograft

2. allograft (i.e., cancellous and/or corticocancellous allograft bone)

3. Attrax Putty (NuVasive) (not applicable for MLX, TLX, or XLX ACR)

5. NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the thoracolumbar spine (unless the interbody device to be used is interfixated and is cleared by the regulatory body to be used standalone)

6. Able to undergo surgery based on physical exam, medical history, and surgeon judgment

7. 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 morphogenetic protein (BMP) (e.g., Infuse (Medtronic))

2. Synthetic bone graft extenders (e.g., Attrax Scaffold (NuVasive), Formagraft (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), 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), Propel Putty/Gel (NuVasive))

4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics))

2. Previous lumbar 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 outcomes 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

University of California San Diego

La Jolla, California, United States

Verma Spine

Los Alamitos, California, United States

Valley Spine Care

Merced, California, United States

Hoag Orthopedics

Orange, California, United States

Hartford Healthcare Bone and Joint Institute

Hartford, Connecticut, United States

Lyerly Neurosurgery

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

DuPage Medical Group

Naperville, Illinois, United States

Beaumont Hospital Research Institute

Royal Oak, Michigan, United States

Columbia Orthopaedics Group

Columbia, Missouri, United States

Duke University

Durham, North Carolina, United States

Atlantic Brain and Spine

Wilmington, North Carolina, United States

Summa Health

Akron, Ohio, United States

Ohio State University

Dublin, Ohio, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

NUVA.LIB1119

Identifier Type: -

Identifier Source: org_study_id