Advanced Materials Science in XLIF Study (AMS in XLIF)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Degenerative Disc Disease; Spondylolisthesis

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Healthcare Bone and Joint Institute
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Lyerly Neurosurgery
    • Tampa, Florida, United States, 33606
      • University of South Florida Department of Neurosurgery, Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Orthopaedic Institute of Western Kentucky
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital, Johns Hopkins Medicine
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopedic Group Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Wilmington, North Carolina, United States, 28401
      • Atlantic Brain and Spine
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • The Spine Clinic of OKC
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Health System
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Fusion Success	The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3, 6, 12, and 24 months
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)	6, 12, 24 months
Maintenance of Radiographic Correction	Percentage of subjects with maintenance of radiographic correction out to 24-months postoperative follow-up within each treatment group	3, 6, 12, and 24 months
Complications	Rate of complications attributable to the use of the interbody implants to be studied	3, 6, 12, and 24 months

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kyle Malone, MS, NuVasive

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: NUVA.X1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No