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The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
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 who meet eligibility requirements will be asked to consent to participate in the study. Once enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months postoperative or later to evaluate their fusion status. If the patient already had a postoperative CT scan at 12 months or greater, this will be used in this study and an additional CT scan should not be performed for this study. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.
The safety and performance of the Modulus XLIF interbody implant will be assessed using the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modulus XLIF Interbody System |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complications | Rate of complications attributable to use of the Modulus XLIF interbody implant | At least 12 months |
| Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative | Proportion of subjects with fusion at 12 months or greater | At least 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in neurologic status | Proportion of subjects with neurological improvement as compared to baseline | At least 12 months |
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Inclusion Criteria:
Male or female patients who are ≥18 years of age at the time of surgery
Treated with XLIF procedure with the Modulus 3D-printed titanium interbody implant at:
Interbody fusion with autograft and/or allograft
Any NuVasive supplemental fixation
Patient is able and to undergo a CT scan. If the patient already had a postoperative CT scan at 12 months or greater, this will be used in this study and an additional CT scan should not be performed for this study.
Patient understands the conditions of enrollment and is willing to sign an informed consent form to participate.
Exclusion Criteria:
Use of any bone graft with the Modulus XLIF interbody implant that is not FDA-cleared for use in the interbody space. Examples of these include:
Previous lumbar fusion surgery at the currently treated level(s) (adjacent-level surgery is acceptable)
Patients with active infection at the surgical site at the time of surgery
Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
Patient is unwilling or unable to undergo a CT scan due to pregnancy or other medical condition
Patient is a prisoner
Patient is participating in another clinical study that would confound study data
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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 who meet eligibility requirements will be asked to consent to participate in the study. Once enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months postoperative or later to evaluate their fusion status.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erik C. Spayde, MD Inc. | Thousand Oaks | California | 91360 | United States | ||
| Georgia Spine & Neurosurgery Center |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Atlanta |
| Georgia |
| 30342 |
| United States |