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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, radiographic outcomes, and clinical patient 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 the MLX and XLX ACR interbody implants.
Full 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 that meet eligibility requirements will be included in the study and available progress notes, medical records, patient-reported outcomes (PROs), radiographs, and complications will be obtained from the medical records.
The safety and performance of the MLX and XLX ACR interbody implants will be assessed using the following:
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Inclusion criteria
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:
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 criteria
Use of any bone graft with the associated interbody implant that is not FDA-cleared for use within interbody implants.
Examples of these include:
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
109 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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