Advanced Materials Science in XLIF Study

NCT03649490 | Enrolling By Invitation

• 1 other identifier: NUVA.X1801
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Degenerative Disc Disease; Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Radiographic Fusion Success

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

  24 months

Secondary Outcomes (4)

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

  3, 6, 12, and 24 months

• Fusion Rates at Follow-up Timepoints

  6, 12, 24 months

• Maintenance of Radiographic Correction

  3, 6, 12, and 24 months

• Complications

  3, 6, 12, and 24 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Smooth PEEK: Coroent XL PEEK (XLIF) + Coroent L (TLIF) or Coroent XLR (ALIF) or Brigade (ALIF)
• D-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.

You may not qualify if:

• 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);
• 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);

Sponsors & Collaborators

• NuVasive: lead

Study Sites (15)

Hartford Healthcare Bone and Joint Institute

Hartford, Connecticut, 06106, United States

Location

Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

University of South Florida Department of Neurosurgery, Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

Suburban Hospital, Johns Hopkins Medicine

Bethesda, Maryland, 20814, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Columbia Orthopedic Group Research

Columbia, Missouri, 65201, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Atlantic Brain and Spine

Wilmington, North Carolina, 28401, United States

Location

The Spine Clinic of OKC

Oklahoma City, Oklahoma, 73114, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Evergreen Health

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Kyle Malone, MS

  Globus Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: August 19, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)