A Prospective, Multicenter Study Evaluating the Safety and Performance of Posterior Fixation in Trauma, Reconstructive, and Tumor Surgery of the Occipito-cervico-thoracic Spine
Details
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.
Eligibility
You can join if...
Inclusion Criteria:
Patients who are >= 18 years of age at the time of consent
Have planned craniocervical, cervical (C1 to C7), and/or upper thoracic (T1-T3) spine surgery using posterior fixation planned for treatment of any of the following conditions:
a. traumatic spinal fractures and/or traumatic dislocations
b. instability or deformity
c. failed previous fusions (e.g., pseudoarthrosis)
d. tumors involving the cervical spine
e. degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability
Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA):
a. Vuepoint II OCT
b. Reline-C
Able to undergo surgery based on physical exam, medical history, and surgeon judgment
Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Exclusion Criteria:
Patient is involved in active litigation relating to the spine (workers' compensation claim is allowed if it is not contested)
Use of bone growth stimulators postoperatively
Active smoking within 6 weeks of 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
Patient is a prisoner
Patient is participating in another clinical study that would confound study data