CClinicalTrials.gg
Enrolling by invitationNCT03649490AMS in XLIFUpdated Dec 22, 2025

Advanced Materials Science in XLIF Study

An observational study in Degenerative Disc Disease and Spondylolisthesis, sponsored by NuVasive. Enrolling by invitation at 15 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by NuVasive · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study is being conducted to evaluate the clinical and radiographic outcomes of three different interbody implant types when used with cancellous allograft chips with BMA or cellular allograft in patients undergoing XLIF surgery. The study will evaluate success by comparing the rate of fusion, complications profile, and any relationships between clinical outcomes (pain and function) and radiographic outcomes (fusion rate) between the three implant groups.

Read the detailed description

This study is a prospective, non-concurrent, multicenter study to compare the clinical and radiographic outcomes of smooth PEEK, 3D-printed titanium, and Porous PEEK interbody implants when used with cancellous allograft chips with BMA or cellular allograft in subjects who undergo XLIF surgery at one or two levels. To minimize selection bias, all 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 lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo their XLIF operation using one of the 3 previously noted interbody implants based on a non-concurrent enrollment schedule. The bone graft material used inside the interbody implant will be randomly assigned between cancellous allograft chips with BMA or cellular allograft prior to surgery based on surgeon investigators' equipoise for the effectiveness of both bone graft materials. Subjects will be followed for 24 months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively.

02

Conditions studied

  • Degenerative Disc Disease
  • Spondylolisthesis
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male and female patients who are 18-80 years of age with planned extreme lateral interbody fusion (XLIF) surgery prior to enrollment in the research at one or two lumbar levels for the treatment of degenerative disc disease, including those with up to Grade 2 spondylolisthesis.

Inclusion criteria

  1. Male and female patients who are 18-80 years of age;
  2. Planned interbody fusion surgery, including at least one level of extreme lateral interbody fusion (XLIF) prior to enrollment in the research at one or two consecutive lumbar levels for degenerative disc disease, including those with up to Grade 2 spondylolisthesis, with one of the following NuVasive, Inc. interbody implants:

    1. Coroent® XL PEEK interbody implant; or
    2. Modulus® 3D-printed titanium interbody implant; or
    3. Cohere® XLIF Porous PEEKTM interbody implant.

    If a transforaminal lumbar interbody fusion or anterior lumbar interbody fusion (TLIF or ALIF) is planned adjacent to the XLIF level, the same NuVasive, Inc. interbody implant material type must be used as determined by the implant enrollment schedule. For example:

    1. Smooth PEEK: Coroent XL PEEK (XLIF) + Coroent L (TLIF) or Coroent XLR (ALIF) or Brigade (ALIF)
    2. 3D-printed titanium: Modulus XLIF + Modulus TLIF or Modulus ALIF
    3. Porous PEEK: Cohere XLIF + Coalesce TLIF (currently no ALIF option)
  3. The planned procedure must include placement of bilateral posterior screw fixation with or without intrafacet fusion using autograft (with or without the assigned allograft used at the XLIF level(s)) at the treated level(s). Direct posterior decompression at the index interbody fusion level(s) is acceptable.
  4. Preoperative coronal Cobb angle of \< 10°;
  5. Able to undergo surgery based on physical exam, medical history, and surgeon judgment;
  6. Understands the conditions of enrollment and willing to sign an informed consent to participate in the evaluation.

Exclusion criteria

Exclusion Criteria:

  1. Use of BMP, synthetic bone graft substitutes, allografts, or any other graft material in the interbody or intrafacet spaces other than those under study;
  2. Posterior grafting other than the allowed intrafacet fusion at the treated level(s);
  3. Revision of prior fusion at treated level(s) (adjacent level interbody fusion is acceptable);
  4. XLIF procedure that requires or results in the release of the anterior longitudinal ligament or posterior osteotomy;
  5. Preoperative coronal Cobb angle of ≥ 10°;
  6. Procedures performed with XLIF interbody implants with integrated vertebral body screw(s);
  7. Active smoking six (6) weeks prior to surgery;
  8. Systemic or local infection (active or latent);
  9. Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease);
  10. Rheumatoid arthritis or other autoimmune disease that, in the option of the investigator, would interfere with bone healing and/or fusion;
  11. Treatment with pharmaceuticals interfering with calcium metabolism;
  12. Undergoing chemotherapy or radiation treatment or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery or anytime postoperatively, other than episodic use or inhaled corticosteroids);
  13. Use of bone stimulators postoperatively;
  14. Non-ambulatory, wheelchair-bound;
  15. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
  16. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease);
  17. Spinal metastases or active spinal tumor malignancy;
  18. Immunocompromised or is being treated with immunosuppressive agents;
  19. Pregnant, or plans to become pregnant during the study;
  20. Mental or physical condition that would limit the ability to comply with study requirements;
  21. Prisoners;
  22. Participating in another clinical study that would confound study data.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Smooth PEEK Interbody Implants in XLIF

    Smooth PEEK interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) provide maximum surface area and structural stability with large central apertures to allow bony through-growth. Multiple length options enable optimal apophyseal support, thus reducing the chance of subsidence. Additionally, lordotic profiles are available to induce proper sagittal alignment.

  • 3D-Printed Titanium Interbody Implants in XLIF

    3D-printed, fully porous titanium interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) have a porous architecture that mimics the porosity and stiffness of bone for reduced stress shielding and improved radiographic imaging. The advanced microporous surface topography creates an ideal environment for bone in-growth.

  • Porous PEEK Interbody Implants in XLIF

    Porous PEEK interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) combine the osseointegration capabilities of porous metal implants with the favorable imaging and mechanical properties of traditional PEEK implants. The Porous PEEK architecture, with 60% porosity and 300 mm average pore size, is specifically tailored to elicit the optimal osteogenic cell response and promote bone tissue ingrowth inside the pores, as demonstrated in preclinical studies.

05

What researchers measure

Primary outcomes

  1. 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. MCID and SCB threshold for each PRO: VAS (back/leg pain), ODI, and EQ-5D, within each treatment group

    Percentage of subjects meeting minimal clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for each patient-reported outcome (PRO): Back and leg pain (visual analog scale (VAS)), disability (Oswestry disability index (ODI)), and quality of life (EQ-5D) within each treatment group.

    Time frame: 3, 6, 12, and 24 months

  2. Fusion Rates at Follow-up Timepoints

    Percentage of subjects with a successful radiographic interbody fusion by each follow-up timepoint (6, 12, and 24-month postoperative follow-up)

    Time frame: 6, 12, 24 months

  3. Maintenance of Radiographic Correction

    Percentage of subjects with maintenance of radiographic correction out to 24-months postoperative follow-up within each treatment group

    Time frame: 3, 6, 12, and 24 months

  4. Complications

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

    Time frame: 3, 6, 12, and 24 months

06

Study locations

15 sites
  • Hartford Healthcare Bone and Joint Institute
    Hartford, Connecticut 06106, United States
  • Lyerly Neurosurgery
    Jacksonville, Florida 32207, United States
  • University of South Florida Department of Neurosurgery, Tampa General Hospital
    Tampa, Florida 33606, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Orthopaedic Institute of Western Kentucky
    Paducah, Kentucky 42001, United States
  • Suburban Hospital, Johns Hopkins Medicine
    Bethesda, Maryland 20814, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Columbia Orthopedic Group Research
    Columbia, Missouri 65201, United States
  • OrthoCarolina
    Charlotte, North Carolina 28207, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Atlantic Brain and Spine
    Wilmington, North Carolina 28401, United States
  • The Spine Clinic of OKC
    Oklahoma City, Oklahoma 73114, United States
  • UT Health San Antonio
    San Antonio, Texas 78229, United States
  • University of Virginia Health System
    Charlottesville, Virginia 22903, United States
  • Evergreen Health
    Kirkland, Washington 98034, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03649490
Lead sponsor
NuVasive
Responsible party
Sponsor
First posted
Aug 28, 2018
Start date
Aug 19, 2018
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 22, 2025

Study contacts

Kyle Malone, MS
study director · Globus Medical

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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