Degenerative Disc DiseaseNCT04418830
Lumbar Interbody Implant Study
An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by NuVasive at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis
- How many people
- 1,050 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Oct 2020to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites
Summa Health
Akron, Ohio, 44320
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60610
Columbia Orthopaedics Group
Columbia, Missouri, 65201
Ohio State University
Dublin, Ohio, 43016
Duke University
Durham, North Carolina, 27710
Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, 06106
Lyerly Neurosurgery
Jacksonville, Florida, 32207
University of California San Diego
La Jolla, California, 92037
Verma Spine
Los Alamitos, California, 90720
Valley Spine Care
Merced, California, 95348
DuPage Medical Group
Naperville, Illinois, 60540
Hoag Orthopedics
Orange, California, 92868
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Beaumont Hospital Research Institute
Royal Oak, Michigan, 48073
Atlantic Brain and Spine
Wilmington, North Carolina, 28401
About this study
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
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.
Read the detailed description
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.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis, Sagittal Deformity
- Keywords
- Spine Surgery, Medical Device
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Base Interfixated System | Not described | |
| Brigade Interfixated System | Not described | |
| Coalesce Thoracolumbar Interbody | Not described | |
| Cohere XLIF Interbody System | Not described | |
| CoRoent Ti PLIF Interbody System | Not described | |
| CoRoent Ti TLIF Interbody System | Not described | |
| MLX - Medial Lateral Expandable Interbody System | Not described | |
| Modulus TLIF Interbody System | Not described | |
| Modulus XLIF Interbody System | Not described | |
| TLX Interbody System | Not described | |
| XLX ACR Interbody System | Not described | |
| CoRoent Ti XLIF Interbody System | Not described | |
| Cohere TLIF | Not described | |
| Modulus ALIF | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of Interbody Implants
Rate of complications attributable to the use of the interbody implants to be studied
Measured: 24 months
Radiographic Fusion Success
The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group
Measured: 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).
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".
Measured: 24 months
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.
Measured: 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.
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, MS, Study director, Globus Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418830
- Sponsor's protocol ID
- NUVA.LIB1119
- Status last verified
- Dec 2025
- First submitted
- 2 Jun 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04418830
- Acronym / sponsor ID
- NUVA.LIB1119
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis, Sagittal Deformity
- Keywords
- Spine Surgery, Medical Device
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (28 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications of Interbody Implants
Time frame: 24 months
Rate of complications attributable to the use of the interbody implants to be studied
Radiographic Fusion Success
Time frame: 24 months
The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group
4 secondary outcomes
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).
Time frame: 24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.
Time frame: 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.
Time frame: 24 months
Complications attributable to the use of any additional NuVasive instruments, implants, or technologies
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Malone, MS study director
Globus Medical
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Degenerative Spondylolisthesis, run by NuVasive at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications of Interbody Implants (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.