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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS). | Back and leg pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (1.2 points and 1.6 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain". | 24 months |
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Inclusion Criteria:
Patients who are ≥18 years of age at the time of consent
Planned spine surgery using interbody implants at:
Use of one of the following implants (NuVasive, Inc., San Diego, CA):
Interbody fusion with one or more of the following (as allowed by implant type):
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
Exclusion Criteria:
Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
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
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The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | Globus Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92037 | United States | ||
| Verma Spine |
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| XLX ACR Interbody System |
| CoRoent Ti XLIF Interbody System |
| Cohere TLIF |
| Modulus ALIF |
| Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index. | Disability measured by the Oswestry disability index (ODI) will be assessed to determine the percentage of subjects who meet MCID (12.8 points) where a higher score on the ODI indicates a more severe disability. | 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. | Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | 24 months |
| Complications attributable to the use of any additional NuVasive instruments, implants, or technologies | Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies | 24 months |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Valley Spine Care | Merced | California | 95348 | United States |
| Hoag Orthopedics | Orange | California | 92868 | United States |
| Hartford Healthcare Bone and Joint Institute | Hartford | Connecticut | 06106 | United States |
| Lyerly Neurosurgery | Jacksonville | Florida | 32207 | United States |
| Northwestern University | Chicago | Illinois | 60610 | United States |
| DuPage Medical Group | Naperville | Illinois | 60540 | United States |
| Beaumont Hospital Research Institute | Royal Oak | Michigan | 48073 | United States |
| Columbia Orthopaedics Group | Columbia | Missouri | 65201 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Atlantic Brain and Spine | Wilmington | North Carolina | 28401 | United States |
| Summa Health | Akron | Ohio | 44320 | United States |
| Ohio State University | Dublin | Ohio | 43016 | United States |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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