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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,050
- 试验地点
- 16
- 主要终点
- Complications of Interbody Implants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Modulus ALIF
- •Modulus TLIF
- •Modulus XLIF
- •Interbody fusion with one or more of the following (as allowed by implant type):
- •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
排除标准
- •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
结局指标
主要结局
Complications of Interbody Implants
时间窗: 24 months
Rate of complications attributable to the use of the interbody implants to be studied
Radiographic Fusion Success
时间窗: 24 months
The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group
次要结局
- Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.(24 months)
- Complications attributable to the use of any additional NuVasive instruments, implants, or technologies(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).(24 months)
- Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.(24 months)