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Enrolling by invitationNCT04418830Updated Dec 22, 2025

Lumbar Interbody Implant Study

An observational study in Degenerative Disc Disease, Degenerative Spondylolisthesis and Degenerative Scoliosis, sponsored by NuVasive. Enrolling by invitation at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by NuVasive (part of Globus Medical) · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,050
Ages
18 Years and older
Sex
All
01

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.

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.

02

Conditions studied

  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Degenerative Scoliosis
  • Spinal Stenosis
  • Sagittal Deformity

Keywords

  • Spine Surgery
  • Medical Device
03

In context

Intervertebral Disc Degeneration

462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.

This study's planned enrollment of 1,050 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

NuVasive is the lead sponsor of 38 studies on the registry; 8 are open to participants now.

First submitted before NuVasive became part of Globus Medical.

Browse NuVasive studies →All Globus Medical studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form to participate in the study

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,050 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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
06

What researchers measure

Primary outcomes

  1. Complications of Interbody Implants

    Rate of complications attributable to the use of the interbody implants to be studied

    Time frame: 24 months

  2. Radiographic Fusion Success

    The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group

    Time frame: 24 months

Secondary outcomes

  1. 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".

    Time frame: 24 months

  2. 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.

    Time frame: 24 months

  3. 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.

    Time frame: 24 months

  4. 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

    Time frame: 24 months

07

Study locations

16 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2020 (actual). Primary completion is estimated for Dec 2025, 62 months after the start.

Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's planned 62 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2020
First posted
Jun 5, 2020
StartActual
Oct 1, 2020
Primary completionEst.
Dec 31, 2025
CompletionEst.
Jul 1, 2026
Last update
Dec 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04418830
Lead sponsor
NuVasive
Responsible party
Sponsor
First posted
Jun 5, 2020
Start date
Oct 1, 2020
Primary completion
Dec 31, 2025 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Dec 22, 2025

Study contacts

Kyle Malone, MS
study director · Globus Medical

Oversight

View the source record on ClinicalTrials.gov ↗

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