Enrolling by invitation
Observational
Lumbar Interbody Implant Study
Condition(s) studied
Degenerative Disc DiseaseDegenerative SpondylolisthesisDegenerative ScoliosisSpinal StenosisSagittal Deformity
Study 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.
Eligibility
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
Primary outcome measure(s)
- Complications of Interbody Implants — 24 months
Rate of complications attributable to the use of the interbody implants to be studied
- Radiographic Fusion Success — 24 months
The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group
Trial sites (16)
| Facility | City | Region | Status |
| University of California San Diego |
La Jolla |
California |
|
| Verma Spine |
Los Alamitos |
California |
|
| Valley Spine Care |
Merced |
California |
|
| Hoag Orthopedics |
Orange |
California |
|
| Hartford Healthcare Bone and Joint Institute |
Hartford |
Connecticut |
|
| Lyerly Neurosurgery |
Jacksonville |
Florida |
|
| Northwestern University |
Chicago |
Illinois |
|
| DuPage Medical Group |
Naperville |
Illinois |
|
| Beaumont Hospital Research Institute |
Royal Oak |
Michigan |
|
| Columbia Orthopaedics Group |
Columbia |
Missouri |
|
| Duke University |
Durham |
North Carolina |
|
| Atlantic Brain and Spine |
Wilmington |
North Carolina |
|
| Summa Health |
Akron |
Ohio |
|
| Ohio State University |
Dublin |
Ohio |
|
| UPMC Presbyterian |
Pittsburgh |
Pennsylvania |
|
| University of Virginia |
Charlottesville |
Virginia |
|
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