Lumbar Interbody Implant Study

A Prospective, Multicenter Study Evaluating the Safety and Performance of Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine

The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and patient-reported outcomes. This study is being undertaken to identify possible residual risks and to clarify mid- to long-term clinical performance that may affect the benefit/risk ratios of these interbody implants.

Study Overview

• Status: Enrolling by invitation
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Degenerative Scoliosis; Degenerative Spondylolisthesis; Sagittal Deformity

Detailed Description

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery. 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 thoracic and/or lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on the surgeon's standard of care. At least 1050 subjects (a minimum of 75 patients in each implant group) will be enrolled and will be followed for 24 months after the surgery.

• Study Type: Observational
• Enrollment (Estimated): 1050

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • Los Alamitos, California, United States, 90720
      • Verma Spine
    • Merced, California, United States, 95348
      • Valley Spine Care
    • Orange, California, United States, 92868
      • Hoag Orthopedics
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Healthcare Bone and Joint Institute
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Lyerly Neurosurgery
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Northwestern University
    • Naperville, Illinois, United States, 60540
      • DuPage Medical Group
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital Research Institute
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopaedics Group
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Wilmington, North Carolina, United States, 28401
      • Atlantic Brain and Spine
  • Ohio
    • Akron, Ohio, United States, 44320
      • Summa Health
    • Dublin, Ohio, United States, 43016
      • Ohio State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:

• Satisfied the inclusion and exclusion criteria
• Signed the informed consent
• Underwent the surgical procedure, as defined in this protocol

Subjects not meeting any of these criteria will not be considered enrolled in the study, and therefore not included in any study population or analysis.

Description

Inclusion Criteria:

1. Patients who are ≥18 years of age at the time of consent

2. Planned spine surgery using interbody implants at:

   1. One or two adjacent thoracic, lumbar, and/or lumbosacral levels for degenerative disc disease or degenerative spondylolisthesis, or
   2. One or two adjacent thoracic, lumbar, and/or lumbosacral levels for spinal stenosis (not applicable for MLX, TLX, or XLX ACR), or
   3. Any number of thoracic, lumbar, and/or lumbosacral levels for degenerative scoliosis (defined as >10º coronal curve), or
   4. Any number of thoracic, lumbar, and/or lumbosacral levels for sagittal deformity (not applicable for MLX, TLX, or XLX ACR).

3. Use of one of the following implants (NuVasive, Inc., San Diego, CA):

   1. Base Interfixated
   2. Brigade Interfixated
   3. Coalesce Thoracolumbar
   4. Cohere TLIF
   5. Cohere XLIF
   6. Coroent Ti PLIF
   7. Coroent Ti TLIF
   8. Coroent Ti XLIF
   9. MLX
   10. Modulus ALIF
   11. Modulus TLIF
   12. Modulus XLIF
   13. TLX
   14. XLX ACR

4. Interbody fusion with one or more of the following (as allowed by implant type):

   1. autograft
   2. allograft (i.e., cancellous and/or corticocancellous allograft bone)
   3. Attrax Putty (NuVasive) (not applicable for MLX, TLX, or XLX ACR)
5. NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the thoracolumbar spine (unless the interbody device to be used is interfixated and is cleared by the regulatory body to be used standalone)
6. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
7. Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study

Exclusion Criteria:

1. Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:

   1. Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
   2. Synthetic bone graft extenders (e.g., Attrax Scaffold (NuVasive), Formagraft (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), ChronOs (Depuy Synthes))
   3. Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g., Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis), Propel Putty/Gel (NuVasive))
   4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
2. Previous lumbar fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
3. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
4. Use of bone growth stimulators postoperatively
5. Active smoking within 6 weeks before surgery
6. Patient has known sensitivity to the materials implanted
7. Systemic or local infection (latent or active) or signs of local inflammation
8. Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcomes based on surgeon judgment
9. Patient is a prisoner
10. Patient is 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

14

Cohorts and Interventions

Group / Cohort
Modulus XLIF Interbody System
Base Interfixated System
Brigade Interfixated System
Coalesce Thoracolumbar Interbody
Cohere XLIF Interbody System
CoRoent Ti PLIF Interbody System
CoRoent Ti TLIF Interbody System
MLX - Medial Lateral Expandable Interbody System
Modulus TLIF Interbody System
TLX Interbody System
XLX ACR Interbody System
CoRoent Ti XLIF Interbody System
Cohere TLIF
Modulus ALIF

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
Complications of Interbody Implants	Rate of complications attributable to the use of the interbody implants to be studied	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.	Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).	Back and leg pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (1.2 points and 1.6 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain".	24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.	Disability measured by the Oswestry disability index (ODI) will be assessed to determine the percentage of subjects who meet MCID (12.8 points) where a higher score on the ODI indicates a more severe disability.	24 months
Complications attributable to the use of any additional NuVasive instruments, implants, or technologies	Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies	24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

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

• Keywords: Spine Surgery; Medical Device
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Spondylolysis; Spondylosis; Scoliosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: NUVA.LIB1119

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.: Yes