Clinical Trial Finder

Lumbar Interbody Implant Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04418830
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 NuVasive
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kyle Malone, MS
Principal Investigator Affiliation NuVasive
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis, Sagittal Deformity
Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Diego, La Jolla, California

Status

Address

University of California San Diego

La Jolla, California, 92037

Verma Spine, Los Alamitos, California

Status

Address

Verma Spine

Los Alamitos, California, 90720

Valley Spine Care, Merced, California

Status

Address

Valley Spine Care

Merced, California, 95348

Hoag Orthopedics, Orange, California

Status

Address

Hoag Orthopedics

Orange, California, 92868

Hartford, Connecticut

Status

Address

Hartford Healthcare Bone and Joint Institute

Hartford, Connecticut, 06106

Lyerly Neurosurgery, Jacksonville, Florida

Status

Address

Lyerly Neurosurgery

Jacksonville, Florida, 32207

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60610

DuPage Medical Group, Naperville, Illinois

Status

Address

DuPage Medical Group

Naperville, Illinois, 60540

Beaumont Hospital Research Institute, Royal Oak, Michigan

Status

Address

Beaumont Hospital Research Institute

Royal Oak, Michigan, 48073

Columbia Orthopaedics Group, Columbia, Missouri

Status

Address

Columbia Orthopaedics Group

Columbia, Missouri, 65201

Duke University, Durham, North Carolina

Status

Address

Duke University

Durham, North Carolina, 27710

Atlantic Brain and Spine, Wilmington, North Carolina

Status

Address

Atlantic Brain and Spine

Wilmington, North Carolina, 28401

Summa Health, Akron, Ohio

Status

Address

Summa Health

Akron, Ohio, 44320

Ohio State University, Dublin, Ohio

Status

Address

Ohio State University

Dublin, Ohio, 43016

UPMC Presbyterian, Pittsburgh, Pennsylvania

Status

Address

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213

University of Virginia, Charlottesville, Virginia

Status

Address

University of Virginia

Charlottesville, Virginia, 22908

Powered By