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The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.
This study is a prospective, single-arm, multicenter study to evaluate the safety and performance of the XLIF Decade Plate in patients undergoing a thoracic and/or lumbar interbody fusion, at one or two levels, with supplemental fixation using a lateral plate. Consecutive patients at a given site who meet all eligibility requirements will be asked to consent to participate in the study. Eligible patients include those 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 in the study, subjects will undergo XLIF surgery with lateral plating using the Decade Plate. At least 75 subjects will be enrolled and will be followed for 24 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XLIF Decade Plate |
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| Measure | Description | Time Frame |
|---|---|---|
| Complication of interbody implant | Rate of device-related complications (i.e., safety) attributable to the use of the Decade Plate System | 24 months |
| Radiographic fusion success | Proportion of subjects with apparent radiographic fusion (i.e., performance) of the index surgical level(s) at 24 months postoperative | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS). | Back and leg pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (1.2 points and 1.6 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain". | 24 months |
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Inclusion Criteria:
Patients who are ≥18 years of age at the time of consent
Planned interbody fusion surgery using the Decade Plate System in conjunction with an interbody implant to treat one or two levels in the thoracic and/or lumbar spine for
Able to undergo surgery based on physical exam, medical history, and surgeon judgment
Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study
Exclusion Criteria:
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The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:
Subjects not meeting any of these criteria will not be considered enrolled in the study, and therefore not included in any study population or analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States |
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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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| Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index. | Disability measured by the Oswestry disability index (ODI) will be assessed to determine the percentage of subjects who meet MCID (12.8 points) where a higher score on the ODI indicates a more severe disability. | 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. | Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | 24 months |
| Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for back/leg pain measured by visual analog scale (VAS). | Back and leg pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet SCB (3.5 points or less, at least a 2.5 point improvement, or at least a 41.4% improvement) where 0 is "No Pain" and 10 is "Unbearable Pain". | 24 months |
| Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the Oswestry disability index. | Disability measured by the Oswestry disability index (ODI) will be assessed to determine the percentage of subjects who meet SCB (at least 18.8 point improvement, at least a 36.8% improvement, or a disability value below 31.3) where a higher score on the ODI indicates a more severe disability. | 24 months |
| Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline measured by overall physical and mental health from PROMIS-10. | Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (7 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | 24 months |
| Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies. | Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies | 24 months |