What this study is
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.
Study details
- Official title
- A Prospective, Multicenter Study Evaluating the Safety and Performance of Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine
- Sponsor
- NuVasive
- Conditions
- Degenerative Disc Disease · Degenerative Spondylolisthesis · Degenerative Scoliosis · Spinal Stenosis · Sagittal Deformity
- Enrolling
- 1,050 people
- Starts
- 2020-10-01
- Est. completion
- 2026-07-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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; MLX; Modulus ALIF; Modulus TLIF; Modulus XLIF; TLX; XLX ACR
- Interbody fusion with one or more of the following (as allowed by implant type):; autograft; allograft (i.e., cancellous and/or corticocancellous allograft bone); Attrax Putty (NuVasive) (not applicable for MLX, TLX, or XLX ACR)
- 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)
- 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
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (16)
16 openUniversity 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
Study team
Sponsor
NuVasive
Study ID NUVA.LIB1119
Study director
Kyle Malone, MS
Globus Medical
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.