Clinical trial NCT04418830: Lumbar Interbody Implant Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degenerative Disc Disease
Degenerative Spondylolisthesis
Degenerative Scoliosis
Spinal Stenosis
Sagittal Deformity
Keywords: Spine Surgery
Medical Device
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complications of Interbody Implants
timeFrame: 24 months
measure: Radiographic Fusion Success
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).
timeFrame: 24 months
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.
timeFrame: 24 months
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.
timeFrame: 24 months
measure: Complications attributable to the use of any additional NuVasive instruments, implants, or technologies
timeFrame: 24 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Alamitos
country: United States
facility: Verma Spine
state: California
city: Merced
country: United States
facility: Valley Spine Care
state: California
city: Orange
country: United States
facility: Hoag Orthopedics
state: California
city: Hartford
country: United States
facility: Hartford Healthcare Bone and Joint Institute
state: Connecticut
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
city: Royal Oak
country: United States
facility: Beaumont Hospital Research Institute
state: Michigan
city: Columbia
country: United States
facility: Columbia Orthopaedics Group
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Wilmington
country: United States
facility: Atlantic Brain and Spine
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Dublin
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Globus Medical
name: Kyle Malone, MS
role: STUDY_DIRECTOR
References: