XLIF Decade Plate System Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Prospective, Multicenter Study Evaluating the Safety and Performance of the NuVasive® XLIF Decade™ Plate System for the Treatment of Patients With Pathologic Conditions of the Thoracic and/or Lumbar Spine

Conditions
-----------------
Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
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 degenerative disc disease spondylolisthesis scoliosis, kyphosis, lordosis spinal stenosis spondylolysis pseudoarthrosis or failed previous spine surgery 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: Use of posterior fixation for the scheduled surgery Note: Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) Use of bone growth stimulators postoperatively Active smoking within 6 weeks before surgery Patient has known sensitivity to materials implanted Systemic or local infection (latent or active) or signs of local inflammation Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment Pregnant, or plans to become pregnant during the study Patient is a prisoner Patient is participating in another clinical study that would confound study data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| XLIF Decade Plate<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |