Clinical trial NCT04770571: Posterior Cervical Fixation Study
Official title: A Prospective, Multicenter Study Evaluating the Safety and Performance of Posterior Fixation in Trauma, Reconstructive, and Tumor Surgery of the Occipito-cervico-thoracic Spine
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degenerative Disc Disease
Craniocervical Injuries
Cervical Radiculopathy
Cervical Disc Disease
Cervical Fusion
Cervical Spine Disease
Cervical Myelopathy
Cervical Instabilities Spine
Thoracic Injury
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled Population

The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:

* Satisfied the inclusion and exclusion criteria,
* Signed the informed consent, and
* Underwent the surgical procedure, as defined in this protocol.

Evaluable Population

The Evaluable Populations will include all subjects who:

* Were included in the Enrolled Populations,
* Completed the study, and
* Had no major protocol deviations.

Brief 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.

Detailed description: 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 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

Primary outcomes:
measure: Complications of Posterior Fixation System
timeFrame: 24 months
measure: Radiographic Success
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).
timeFrame: 24 months
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index.
timeFrame: 24 months
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.
timeFrame: 24 months
measure: 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).
timeFrame: 24 months
measure: Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index.
timeFrame: 24 months
measure: Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline measured by overall physical and mental health from PROMIS-10.
timeFrame: 24 months
measure: Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies
timeFrame: 24 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: New York
country: United States
facility: NY Spine Institute
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: NuVasive
name: Kyle Malone, MS
role: STUDY_DIRECTOR
References: