Advanced Materials Science in XLIF Study (AMS in XLIF)

• ClinicalTrials.gov Identifier: NCT03649490
• Recruitment Status: Enrolling by invitation
• First Posted: August 28, 2018
• Last Update Posted: October 4, 2022
• Sponsor: NuVasive
• Information provided by (Responsible Party): NuVasive

Tracking Information

• First Submitted Date: August 24, 2018
• First Posted Date: August 28, 2018
• Last Update Posted Date: October 4, 2022
• Actual Study Start Date: August 19, 2018
• Estimated Primary Completion Date: August 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 24, 2018)

Radiographic Fusion Success [ Time Frame: 24 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 21, 2019)

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

Original Secondary Outcome Measures (submitted: August 24, 2018)

• 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.
• Fusion Rates at Follow-up Timepoints [ Time Frame: 6, 12, 24 months ]
  Percentage of subjects successfully fused at each timepoint (6, 12, and 24-month postoperative follow-up)
• 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
• Complications [ Time Frame: 3, 6, 12, and 24 months ]
  Rate of complications attributable to the use of the implants to be studied

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Advanced Materials Science in XLIF Study
• Official Title: A Prospective Multicenter Study Evaluating the Effect of Implant Material and/or Surface Structure on Progression of Fusion in XLIF® Surgery
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Degenerative Disc Disease
• Spondylolisthesis

• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: August 24, 2018): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2024
• Estimated Primary Completion Date: August 1, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03649490
• Other Study ID Numbers: NUVA.X1801
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: NuVasive
• Original Responsible Party: Same as current
• Current Study Sponsor: NuVasive
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Kyle Malone, MS; NuVasive

• PRS Account: NuVasive
• Verification Date: September 2022