Advanced Materials Science in XLIF Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male and female patients who are 18-80 years of age; 2. Planned extreme lateral interbody fusion (XLIF) procedure prior to enrollment in the research at one or two lumbar levels for degenerative disc disease, including those with up to Grade 2 spondylolisthesis, with one of the following interbody implants: 1. CoRoent® XL PEEK (NuVasive, Inc., San Diego, CA) interbody implant; or 2. Modulus® 3D-printed titanium (NuVasive, Inc.) interbody implant; or 3. Porous PEEKTM interbody implant (NuVasive, Inc.). 3. The planned XLIF procedure must include placement of bilateral posterior screw fixation with or without intrafacet fusion using autograft (with or without the assigned allograft used in the anterior interbody fusion) at the treated level(s). Direct posterior decompression at the index XLIF levels 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. Lumbar pathologies requiring additional treatment (excluding decompression) beyond the index XLIF level(s); 3. Posterior grafting other than the allowed intrafacet fusion at the treated level(s); 4. Revision of prior fusion at treated level(s) (adjacent level interbody fusion is acceptable); 5. Procedure that requires or results in the release of the anterior longitudinal ligament or posterior osteotomy; 6. Preoperative coronal Cobb angle of ≥ 10°; 7. Procedures performed with interbody implants with integrated vertebral body screw(s); 8. Active smoking six
  • (6) weeks prior to surgery; 9.
Systemic or local infection (active or latent); 10. Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease); 11. Rheumatoid arthritis or other autoimmune disease; 12. Treatment with pharmaceuticals interfering with calcium metabolism; 13. 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); 14. Use of bone stimulators postoperatively; 15. Non-ambulatory, wheelchair-bound; 16. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested); AMS in XLIF® Study Version Date: July 12, 2019 NuVasive®, Inc.
  • - CONFIDENTIAL NUVA.
X1801 Page 12 of 20 17. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease); 18. Spinal metastases or active spinal tumor malignancy; 19. Immunocompromised or is being treated with immunosuppressive agents; 20. Pregnant, or plans to become pregnant during the study; 21. Mental or physical condition that would limit the ability to comply with study requirements; 22. Prisoners; 23. Participating in another clinical study that would confound study data.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03649490
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NuVasive
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kyle Malone, MS
Principal Investigator Affiliation NuVasive
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease, Spondylolisthesis
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Procedure: - Extreme Lateral Interbody Fusion

Lateral interbody spinal fusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lyerly Neurosurgery, Jacksonville, Florida

Status

Address

Lyerly Neurosurgery

Jacksonville, Florida, 32207

Tampa, Florida

Status

Address

University of South Florida Department of Neurosurgery, Tampa General Hospital

Tampa, Florida, 33606

Rush University Medical Center, Chicago, Illinois

Status

Address

Rush University Medical Center

Chicago, Illinois, 60612

Columbia Orthopedic Group Research, Columbia, Missouri

Status

Address

Columbia Orthopedic Group Research

Columbia, Missouri, 65201

OrthoCarolina, Charlotte, North Carolina

Status

Address

OrthoCarolina

Charlotte, North Carolina, 28207

The Spine Clinic of OKC, Oklahoma City, Oklahoma

Status

Address

The Spine Clinic of OKC

Oklahoma City, Oklahoma, 73114

UT Health San Antonio, San Antonio, Texas

Status

Address

UT Health San Antonio

San Antonio, Texas, 78229

University of Virginia Health System, Charlottesville, Virginia

Status

Address

University of Virginia Health System

Charlottesville, Virginia, 22903