Posterior Cervical Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cervical Disc Disease
- Cervical Fusion
- Cervical Instabilities Spine
- Cervical Myelopathy
- Cervical Radiculopathy
- Cervical Spine Disease
- Craniocervical Injuries
- Degenerative Disc Disease
- Thoracic Injury
- 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, uncontrolled, multicenter study to evaluate the safety and performance of select occipito-cervico-thoracic posterior fixation systems in patients who undergo posterior fixation fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be...
This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select occipito-cervico-thoracic posterior fixation systems in patients who undergo posterior fixation fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with traumatic, reconstructive, and/or tumor conditions in the craniocervical, cervical, and/or upper thoracic spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo posterior occipito-cervico-thoracic fixation surgery using one of the NuVasive posterior fixation systems (Vuepoint II OCT or Reline-C) based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 in each implant arm) will be enrolled and will be followed for 24 months after the surgery.
Tracking Information
- NCT #
- NCT04770571
- Collaborators
- Not Provided
- Investigators
- Study Director: Kyle Malone, MS NuVasive