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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MLX - Medial Lateral Expandable Lumbar Interbody System | Patients who underwent lumbar interbody fusion with the MLX expandable interbody implant will be included in the MLX - Medial Lateral Expandable Lumbar Interbody System cohort. | ||
| XLX ACR Interbody System | Patients who underwent lumbar interbody fusion with the XLX ACR expandable interbody implant will be included in the XLX ACR Interbody System cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complications | Rate of complications (i.e., safety) attributable to use of the associated interbody implants (MLX or XLX ACR) | At least three months |
| Proportion of Subjects with Improvement in Neurological Symptoms | The rate of improvement as compared to baseline in preoperative neurological symptoms will be measured using a standard motor/sensory neurological exam. | At least three months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects with Apparent Radiographic Fusion | Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative, as imaging is available | 12 months or greater |
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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
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At least 90 (75 MLX, 15 XLX ACR) subjects will be enrolled in this multicenter study by at least four investigative sites. A site may have more than one surgeon investigator contributing to the total site enrollment. As a retrospective study, enrollment goals will be determined with the surgeon investigator during site selection by the Sponsor and will be based on available case volume. The site will identify potential subjects who are more than three months from the surgery postoperative time point during the study duration for inclusion in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Specialty Institute | Orange | California | 92868 | United States | ||
| Lyerly Neurosurgery |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| Jacksonville |
| Florida |
| 32207 |
| United States |
| Carolina NeuroSurgery & Spine Associates | Charlotte | North Carolina | 28204 | United States |
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | United States |
| D055009 |
| Spondylosis |