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Degenerative Disc DiseaseAMS in XLIFNCT03649490

Advanced Materials Science in XLIF Study

An observational study of Degenerative Disc Disease and Spondylolisthesis, run by NuVasive at 15 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Degenerative Disc Disease, Spondylolisthesis
How many people
300 participants
Where
15 sitesUnited States
Study dates
19 Aug 2018to 31 Dec 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Male and female patients who are 18-80 years of age;
  • 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:
  • Coroent® XL PEEK interbody implant; or
  • Modulus® 3D-printed titanium interbody implant; or
  • 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:
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  • Smooth PEEK: Coroent XL PEEK (XLIF) + Coroent L (TLIF) or Coroent XLR (ALIF) or Brigade (ALIF)
  • 3D-printed titanium: Modulus XLIF + Modulus TLIF or Modulus ALIF
  • Porous PEEK: Cohere XLIF + Coalesce TLIF (currently no ALIF option)
  • 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.
  • Preoperative coronal Cobb angle of < 10°;
  • Able to undergo surgery based on physical exam, medical history, and surgeon judgment;
  • Understands the conditions of enrollment and willing to sign an informed consent to participate in the evaluation.

Who cannot join

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

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

15 sites in 1 country

United States15 sites

  • Suburban Hospital, Johns Hopkins Medicine

    Bethesda, Maryland, 20814

  • OrthoCarolina

    Charlotte, North Carolina, 28207

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Columbia Orthopedic Group Research

    Columbia, Missouri, 65201

  • Duke University

    Durham, North Carolina, 27710

  • Hartford Healthcare Bone and Joint Institute

    Hartford, Connecticut, 06106

  • Lyerly Neurosurgery

    Jacksonville, Florida, 32207

  • Evergreen Health

    Kirkland, Washington, 98034

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • The Spine Clinic of OKC

    Oklahoma City, Oklahoma, 73114

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky, 42001

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • University of South Florida Department of Neurosurgery, Tampa General Hospital

    Tampa, Florida, 33606

  • Atlantic Brain and Spine

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Prospective Multicenter Study Evaluating the Effect of Implant Material and/or Surface Structure on Progression of Fusion in XLIF® Surgery

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.

Medical subject headings
Intervertebral Disc Degeneration, Spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03649490
Study groupRoleWhat they receive
Smooth PEEK Interbody Implants in XLIFSmooth 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 XLIF3D-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 XLIFPorous 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  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.

    Measured: 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)

    Measured: 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

    Measured: 3, 6, 12, and 24 months

  4. Complications

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

    Measured: 3, 6, 12, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start19 Aug 2018
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649490
Sponsor's protocol ID
NUVA.X1801
Acronym
AMS in XLIF
Status last verified
Dec 2025
First submitted
24 Aug 2018
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease and Spondylolisthesis, run by NuVasive at 15 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 13 inclusion and 22 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 15 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?

Radiographic Fusion Success (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649490.

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.

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