XLIF Decade Plate System Study

Completed

Conditions studied: Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis

In brief

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.

Key facts

Study ID

NCT04689880

Run by

NuVasive

People needed

75

Starts

2021-04-12

Expected to finish

2023-04-01

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study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

Where it is running

• Loma Linda University — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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