Lumbar Interbody Implant Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis, Sagittal Deformity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are ≥18 years of age at the time of consent Planned spine surgery using interbody implants at: One or two adjacent thoracic, lumbar, and/or lumbosacral levels for degenerative disc disease or degenerative spondylolisthesis, or One or two adjacent thoracic, lumbar, and/or lumbosacral levels for spinal stenosis (not applicable for MLX, TLX, or XLX ACR), or Any number of thoracic, lumbar, and/or lumbosacral levels for degenerative scoliosis (defined as >10º coronal curve), or Any number of thoracic, lumbar, and/or lumbosacral levels for sagittal deformity (not applicable for MLX, TLX, or XLX ACR). Use of one of the following implants (NuVasive, Inc., San Diego, CA): Base Interfixated Brigade Interfixated Coalesce Thoracolumbar Cohere TLIF Cohere XLIF Coroent Ti PLIF Coroent Ti TLIF Coroent Ti XLIF MLX Modulus ALIF Modulus TLIF Modulus XLIF TLX XLX ACR Interbody fusion with one or more of the following (as allowed by implant type): autograft allograft (i.e., cancellous and/or corticocancellous allograft bone) Attrax Putty (NuVasive) (not applicable for MLX, TLX, or XLX ACR) 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) Able to undergo surgery based on physical exam, medical history, and surgeon judgment 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: Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include: Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic)) 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)) 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)) Peptide enhanced bone graft (e.g., iFactor (Cerapedics)) Previous lumbar fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable) Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) Use of bone growth stimulators postoperatively Active smoking within 6 weeks before surgery Patient has known sensitivity to the materials implanted Systemic or local infection (latent or active) or signs of local inflammation Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcomes based on surgeon judgment Patient is a prisoner Patient is participating in another clinical study that would confound study data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Base Interfixated System<br> | |
| Brigade Interfixated System<br> | |
| Coalesce Thoracolumbar Interbody<br> | |
| Cohere XLIF Interbody System<br> | |
| CoRoent Ti PLIF Interbody System<br> | |
| CoRoent Ti TLIF Interbody System<br> | |
| MLX - Medial Lateral Expandable Interbody System<br> | |
| Modulus TLIF Interbody System<br> | |
| Modulus XLIF Interbody System<br> | |
| TLX Interbody System<br> | |
| XLX ACR Interbody System<br> | |
| CoRoent Ti XLIF Interbody System<br> | |
| Cohere TLIF<br> | |
| Modulus ALIF<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of Interbody Implants | Rate of complications attributable to the use of the interbody implants to be studied | 24 months | 
| Radiographic Fusion Success | The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine Surgery, Medical Device