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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- NuVasive
- Enrollment
- 1050
- Locations
- 16
- Primary Endpoint
- Complications of Interbody Implants
- Status
- Enrolling By Invitation
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Complications of Interbody Implants
Time Frame: 24 months
Rate of complications attributable to the use of the interbody implants to be studied
Radiographic Fusion Success
Time Frame: 24 months
The proportion of subjects with apparent radiographic fusion at or before 24 months within each treatment group
Secondary Outcomes
- 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 measured by overall physical and mental health from PROMIS-10.(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)