Advanced Materials Science in XLIF Study

NCT ID: NCT03649490

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-19
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuVasive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Malone, MS

Role: STUDY_DIRECTOR

Globus Medical

Locations

Hartford Healthcare Bone and Joint Institute

Hartford, Connecticut, United States

Lyerly Neurosurgery

Jacksonville, Florida, United States

University of South Florida Department of Neurosurgery, Tampa General Hospital

Tampa, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, United States

Suburban Hospital, Johns Hopkins Medicine

Bethesda, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

Columbia Orthopedic Group Research

Columbia, Missouri, United States

OrthoCarolina

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

Atlantic Brain and Spine

Wilmington, North Carolina, United States

The Spine Clinic of OKC

Oklahoma City, Oklahoma, United States

UT Health San Antonio

San Antonio, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Evergreen Health

Kirkland, Washington, United States

Countries

United States

Other Identifiers

NUVA.X1801

Identifier Type: -

Identifier Source: org_study_id