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Spine implant showdown: which material fuses best?

NCT ID NCT03649490

Disease control Sponsor: NuVasive Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 300 adults aged 18-80 who need spinal fusion surgery for degenerative disc disease or spondylolisthesis. It compares three types of interbody implants (PEEK, 3D-printed titanium, and another) used with bone graft material. Researchers will track how well the bones fuse over 24 months and whether patients report less pain and better function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spinal implant (PEEK or 3D-printed titanium) with bone graft
What this could lead to
If successful, this study could help surgeons choose the best implant material for spinal fusion, potentially improving fusion rates and reducing pain.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove one implant is better. Fusion success depends on many factors, and individual outcomes vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantic Brain and Spine

    Wilmington, North Carolina, 28401, United States

  • Columbia Orthopedic Group Research

    Columbia, Missouri, 65201, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Evergreen Health

    Kirkland, Washington, 98034, United States

  • Hartford Healthcare Bone and Joint Institute

    Hartford, Connecticut, 06106, United States

  • Lyerly Neurosurgery

    Jacksonville, Florida, 32207, United States

  • OrthoCarolina

    Charlotte, North Carolina, 28207, United States

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky, 42001, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Suburban Hospital, Johns Hopkins Medicine

    Bethesda, Maryland, 20814, 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 Minnesota

    Minneapolis, Minnesota, 55455, United States

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

    Tampa, Florida, 33606, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22903, United States

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