- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04689880
XLIF Decade Plate System Study
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
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:
- Satisfied the inclusion and exclusion criteria
- Signed the informed consent
- Underwent the surgical procedure, as defined in this protocol
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.
Description
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Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
XLIF Decade Plate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complication of interbody implant
Time Frame: 24 months
|
Rate of device-related complications (i.e., safety) attributable to the use of the Decade Plate System
|
24 months
|
Radiographic fusion success
Time Frame: 24 months
|
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 measured by overall physical and mental health from PROMIS-10.
Time Frame: 24 months
|
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 minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).
Time Frame: 24 months
|
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.
Time Frame: 24 months
|
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 substantial clinical benefit (SCB) as compared to baseline for back/leg pain measured by visual analog scale (VAS).
Time Frame: 24 months
|
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.
Time Frame: 24 months
|
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.
Time Frame: 24 months
|
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.
Time Frame: 24 months
|
Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kyle Malone, MS, NuVasive
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUVA.DEC0820
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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