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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vuepoint II OCT |
| ||
| Reline-C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational study | Device | observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications of Posterior Fixation System | Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system. | 24 months |
| Radiographic Success | The proportion of subjects with apparent radiographic success at:
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS). | Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (2.5 points and 2.5 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain". | 24 months |
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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:
Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA):
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:
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Enrolled Population
The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:
Evaluable Population
The Evaluable Populations will include all subjects who:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine Medical Center | Orange | California | 92868 | United States | ||
| Hartford Healthcare Bone & Joint Institute |
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| Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index. | Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet MCID (7.5 points) where a higher score on the NDI indicates a more severe disability. | 24 months |
| Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10. | Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | 24 months |
| Percentage of subjects meeting substantial clinical benefit (SCB) for neck/arm pain as compared to baseline for neck/arm pain measured by visual analog scale (VAS). | Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet SCB (3.5 points) where 0 is "No Pain" and 10 is "Unbearable Pain". | 24 months |
| Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index. | Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet SCB (9.5 points) where a higher score on the NDI indicates a more severe disability. | 24 months |
| Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline measured by overall physical and mental health from PROMIS-10. | Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet SCB (6.8 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. | 24 months |
| Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies | Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies. | 24 months |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| MedStar Health Research Institute | Hyattsville | Maryland | 20782 | United States |
| NY Spine Institute | New York | New York | 10003 | United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D020196 | Trauma, Nervous System |
| D011843 | Radiculopathy |
| D007714 | Klippel-Feil Syndrome |
| D013898 | Thoracic Injuries |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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