Lumbar Interbody Implant Study

NCT04418830 | Enrolling By Invitation

• 1 other identifier: NUVA.LIB1119
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 16

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.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Scoliosis; Sagittal Deformity; Spinal Stenosis

Keywords

Spine Surgery; Medical Device

Outcome Measures

Primary Outcomes (2)

• Complications of Interbody Implants

  Rate of complications attributable to the use of the interbody implants to be studied

  24 months

• Radiographic Fusion Success

  The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group

  24 months

Secondary Outcomes (4)

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).

  24 months

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.

  24 months

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.

  24 months

• Complications attributable to the use of any additional NuVasive instruments, implants, or technologies

  24 months

Study Arms (14)

Base Interfixated System

Brigade Interfixated System

Coalesce Thoracolumbar Interbody

Cohere XLIF Interbody System

CoRoent Ti PLIF Interbody System

CoRoent Ti TLIF Interbody System

MLX - Medial Lateral Expandable Interbody System

Modulus TLIF Interbody System

Modulus XLIF Interbody System

TLX Interbody System

XLX ACR Interbody System

CoRoent Ti XLIF Interbody System

Cohere TLIF

Modulus ALIF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who: * Satisfied the inclusion and exclusion criteria * Signed the informed consent * Underwent the surgical procedure, as defined in this protocol Subjects not meeting any of these criteria will not be considered enrolled in the study, and therefore not included in any study population or analysis.

You may qualify if:

• Patients who are ≥18 years of age at the time of consent
• Planned spine surgery using interbody implants at:
• One or two adjacent thoracic, lumbar, and/or lumbosacral levels for degenerative disc disease or degenerative spondylolisthesis, or
• One or two adjacent thoracic, lumbar, and/or lumbosacral levels for spinal stenosis (not applicable for MLX, TLX, or XLX ACR), or
• Any number of thoracic, lumbar, and/or lumbosacral levels for degenerative scoliosis (defined as \>10º coronal curve), or
• Any number of thoracic, lumbar, and/or lumbosacral levels for sagittal deformity (not applicable for MLX, TLX, or XLX ACR).
• Use of one of the following implants (NuVasive, Inc., San Diego, CA):
• Base Interfixated
• Brigade Interfixated
• Coalesce Thoracolumbar
• Cohere TLIF
• Cohere XLIF
• Coroent Ti PLIF
• Coroent Ti TLIF
• Coroent Ti XLIF

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 morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
• 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))
• 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))
• Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
• Previous lumbar 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 outcomes based on surgeon judgment
• Patient is a prisoner
• Patient is participating in another clinical study that would confound study data

Sponsors & Collaborators

• NuVasive: lead

Study Sites (16)

University of California San Diego

La Jolla, California, 92037, United States

Location

Verma Spine

Los Alamitos, California, 90720, United States

Location

Valley Spine Care

Merced, California, 95348, United States

Location

Hoag Orthopedics

Orange, California, 92868, United States

Location

Hartford Healthcare Bone and Joint Institute

Hartford, Connecticut, 06106, United States

Location

Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

Northwestern University

Chicago, Illinois, 60610, United States

Location

DuPage Medical Group

Naperville, Illinois, 60540, United States

Location

Beaumont Hospital Research Institute

Royal Oak, Michigan, 48073, United States

Location

Columbia Orthopaedics Group

Columbia, Missouri, 65201, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Atlantic Brain and Spine

Wilmington, North Carolina, 28401, United States

Location

Summa Health

Akron, Ohio, 44320, United States

Location

Ohio State University

Dublin, Ohio, 43016, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kyle Malone, MS

  Globus Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)