Posterior Cervical Fixation Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients who are ≥18 years of age at the time of consent. 2. 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: 1. traumatic spinal fractures and/or traumatic dislocations. 2. instability or deformity. 3. failed previous fusions (e.g., pseudoarthrosis) 4. tumors involving the cervical spine. 5. 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. 3. Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA): 1. Vuepoint II OCT. 2. Reline-C. 4. Able to undergo surgery based on physical exam, medical history, and surgeon judgment. 5. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study.

Exclusion Criteria:

1. Patient is involved in active litigation relating to the spine (workers' compensation claim is allowed if it is not contested) 2. Use of bone growth stimulators postoperatively. 3. Active smoking within 6 weeks of surgery. 4. Patient has known sensitivity to materials implanted. 5. Systemic or local infection (latent or active) or signs of local inflammation. 6. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment. 7. Pregnant, or plans to become pregnant. 8. Patient is a prisoner. 9. Patient is participating in another clinical study that would confound study data

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04770571
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NuVasive
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kyle Malone, MS
Principal Investigator Affiliation	NuVasive
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease, Cervical Fusion, Cervical Spine Disease, Cervical Myelopathy, Cervical Instabilities Spine, Thoracic Injury

Additional 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.

Arms & Interventions

Arms

: Vuepoint II OCT

: Reline-C

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC Irvine Medical Center, Orange, California

Status

Address

UC Irvine Medical Center

Orange, California, 92868

MedStar Health Research Institute, Hyattsville, Maryland

Status

Address

MedStar Health Research Institute

Hyattsville, Maryland, 20782

NY Spine Institute, New York, New York

Status

Address

NY Spine Institute

New York, New York, 10003

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Houston Methodist, Houston, Texas

Status

Address

Houston Methodist

Houston, Texas, 77030

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