Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Advanced Materials Science in XLIF Study (AMS in XLIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649490
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2018
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
NuVasive

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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Spondylolisthesis Procedure: Extreme Lateral Interbody Fusion

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multicenter Study Evaluating the Effect of Implant Material and/or Surface Structure on Progression of Fusion in XLIF® Surgery
Actual Study Start Date : August 19, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: Extreme Lateral Interbody Fusion
Lateral interbody spinal fusion
Other Name: XLIF

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.
Procedure: Extreme Lateral Interbody Fusion
Lateral interbody spinal fusion
Other Name: XLIF

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.
Procedure: Extreme Lateral Interbody Fusion
Lateral interbody spinal fusion
Other Name: XLIF




Primary Outcome Measures :
  1. Radiographic Fusion Success [ Time Frame: 24 months ]
    The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group


Secondary Outcome Measures :
  1. MCID and SCB threshold for each PRO: VAS (back/leg pain), ODI, and EQ-5D, within each treatment group [ Time Frame: 3, 6, 12, and 24 months ]
    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.

  2. Fusion Rates at Follow-up Timepoints [ Time Frame: 6, 12, 24 months ]
    Percentage of subjects with a successful radiographic interbody fusion by each follow-up timepoint (6, 12, and 24-month postoperative follow-up)

  3. Maintenance of Radiographic Correction [ Time Frame: 3, 6, 12, and 24 months ]
    Percentage of subjects with maintenance of radiographic correction out to 24-months postoperative follow-up within each treatment group

  4. Complications [ Time Frame: 3, 6, 12, and 24 months ]
    Rate of complications attributable to the use of the interbody implants to be studied



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649490


Locations
Layout table for location information
United States, Florida
Lyerly Neurosurgery
Jacksonville, Florida, United States, 32207
University of South Florida Department of Neurosurgery, Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Missouri
Columbia Orthopedic Group Research
Columbia, Missouri, United States, 65201
United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
United States, Oklahoma
The Spine Clinic of OKC
Oklahoma City, Oklahoma, United States, 73114
United States, Texas
UT Health San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
NuVasive
Investigators
Layout table for investigator information
Study Director: Kyle Malone, MS NuVasive

Layout table for additonal information
Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT03649490     History of Changes
Other Study ID Numbers: NUVA.X1801
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis