Posterior Cervical Fixation Study (NCT04770571) | Clinical Trial Compass
By InvitationNot Applicable
Posterior Cervical Fixation Study
United States150 participantsStarted 2022-05-10
Plain-language summary
The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).This study is being undertaken to identify possible residual risks and to clarify mid-to long-term clinical performance that may affect the benefit/risk ratio of posterior fixation systems.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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):
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