Spine implant showdown: which material fuses best?
NCT ID NCT03649490
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
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
15 sites. The list below names each one and where it is.
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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.
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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
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Atlantic Brain and Spine
Wilmington, North Carolina, 28401, United States
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Columbia Orthopedic Group Research
Columbia, Missouri, 65201, United States
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Duke University
Durham, North Carolina, 27710, United States
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Evergreen Health
Kirkland, Washington, 98034, United States
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Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, 06106, United States
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Lyerly Neurosurgery
Jacksonville, Florida, 32207, United States
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OrthoCarolina
Charlotte, North Carolina, 28207, United States
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Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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Suburban Hospital, Johns Hopkins Medicine
Bethesda, Maryland, 20814, United States
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The Spine Clinic of OKC
Oklahoma City, Oklahoma, 73114, United States
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UT Health San Antonio
San Antonio, Texas, 78229, United States
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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University of South Florida Department of Neurosurgery, Tampa General Hospital
Tampa, Florida, 33606, United States
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University of Virginia Health System
Charlottesville, Virginia, 22903, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a brace and targeted exercises ease spondylolisthesis pain?