Status:
COMPLETED
MLX/XLX ACR Expandable Lumbar Interbody Implants
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease
Spondylolisthesis
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiog...
Detailed Description
Patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site with surgeries ...
Eligibility Criteria
Inclusion
- Patients who were ≥18 years of age at the time of surgery
- Underwent spine surgery using either MLX or XLX ACR interbody implant (NuVasive, Inc., San Diego, CA) at:
- One or two adjacent thoracic and/or lumbar levels for degenerative disc disease or degenerative spondylolisthesis, or
- Any number of thoracic and/or lumbar levels for degenerative scoliosis (defined as \>10º coronal curve)
- Interbody fusion with autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone)
- NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the thoracolumbar spine
Exclusion
- Use of any bone graft with the associated interbody implant that is not FDA-cleared for use within interbody implants.
- Examples of these include:
- Bone morphogenetic protein (BMP) (e.g., Infuse (Medtronic))
- Synthetic bone graft extenders (e.g., AttraX (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 currently treated level(s) (adjacent-level surgery is acceptable)
- Systemic or local infection (latent or active) or signs of local inflammation documented at the time of surgery
- Patient was involved in active litigation relating to the spine during the surgical/postoperative period (worker's compensation claim is allowed if it is not contested)
- Inadequate bone stock or bone quality documented at the time of surgery
- Known sensitivity to materials implanted documented at the time of surgery
Key Trial Info
Start Date :
January 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04420143
Start Date
January 27 2020
End Date
October 23 2020
Last Update
December 22 2025
Active Locations (4)
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1
Orthopaedic Specialty Institute
Orange, California, United States, 92868
2
Lyerly Neurosurgery
Jacksonville, Florida, United States, 32207
3
Carolina NeuroSurgery & Spine Associates
Charlotte, North Carolina, United States, 28204
4
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207