XLIF Decade Plate System Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disc Disease
- Degenerative Scoliosis
- Degenerative Spondylolisthesis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 wh...
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.
Tracking Information
- NCT #
- NCT04689880
- Collaborators
- Not Provided
- Investigators
- Study Director: Kyle Malone, MS NuVasive
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