Phase
Condition
Peripheral Neuropathy
Neck Pain
Radiculopathy
Treatment
observational study
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 followingconditions:
traumatic spinal fractures and/or traumatic dislocations
instability or deformity
failed previous fusions (e.g., pseudoarthrosis)
tumors involving the cervical spine
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):
Vuepoint II OCT
Reline-C
Able to undergo surgery based on physical exam, medical history, and surgeonjudgment
Understands the conditions of enrollment and is willing to sign an informed consentform to participate in the study
Exclusion
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 conditionthat 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
Study Design
Study Description
Connect with a study center
UC Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
MedStar Health Research Institute
Hyattsville, Maryland 20782
United StatesSite Not Available
NY Spine Institute
New York, New York 10003
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Houston Methodist
Houston, Texas 77030
United StatesSite Not Available
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