Status:
COMPLETED
XLIF Decade Plate System Study
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease
Degenerative Spondylolisthesis
Eligibility:
All Genders
18+ years
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 repor...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study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
Key Trial Info
Start Date :
April 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04689880
Start Date
April 12 2021
End Date
April 1 2023
Last Update
December 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Loma Linda University
Loma Linda, California, United States, 92350