Degenerative Disc DiseaseNCT04770571

Posterior Cervical Fixation Study

An observational study of Degenerative Disc Disease and Craniocervical Injuries, run by NuVasive at 7 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy
What is being tested?: observational study
Type of treatment: Medical device
How many people: 150 participants
Where: 7 sitesUnited States
Study dates: 10 May 2022to Nov 2028
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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:
traumatic spinal fractures and/or traumatic dislocations
instability or deformity
failed previous fusions (e.g., pseudoarthrosis)
tumors involving the cervical spine

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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 surgeon judgment
Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

Who cannot join

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

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Pregnant, or plans to become pregnant
Patient is a prisoner
Patient is participating in another clinical study that would confound study data

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Hartford Healthcare Bone & Joint Institute
Hartford, Connecticut, 06106
Houston Methodist
Houston, Texas, 77030
MedStar Health Research Institute
Hyattsville, Maryland, 20782
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NY Spine Institute
New York, New York, 10003
UC Irvine Medical Center
Orange, California, 92868
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this 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

Read the 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.

Conditions: Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease, Cervical Fusion, Cervical Spine Disease
Being tested: observational study
Medical subject headings: Intervertebral Disc Degeneration, Trauma, Nervous System, Radiculopathy, Klippel-Feil Syndrome, Thoracic Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

observational studyDevice
observational

Study groups in NCT04770571
Study group	Role	What they receive
Vuepoint II OCT		Not described Receives: Device: observational study
Reline-C		Not described Receives: Device: observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

Complications of Posterior Fixation System
Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system.
Measured: 24 months
Radiographic Success
The proportion of subjects with apparent radiographic success at:
1. Latest timepoint available for patients undergoing surgery to treat advanced stage tumors
2. 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease
Measured: 24 months

Secondary outcomes (7)

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".
Measured: 24 months
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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 2022Nov 2028

First posted25 Feb 2021
Study start10 May 2022
Primary completionSep 2026 (estimated)
Study completionNov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04770571
Sponsor's protocol ID: NUVA.PCF1020
Status last verified: Dec 2025
First submitted: 22 Feb 2021
Last updated: 22 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04770571
Acronym / sponsor ID: NUVA.PCF1020
Conditions: Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease, Cervical Fusion, Cervical Spine Disease
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 150 participants (estimated)
Lead sponsor: NuVasiveIndustry (pharma, biotech, devices)
Study start: 10 May 2022 (actual)
Primary completion: Sep 2026 (estimated)
Study completion: Nov 2028 (estimated)
First posted: 25 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Vuepoint II OCT	–	Device: observational study
Reline-C	–	Device: observational study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (12 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
observational studyobservational	Device	Reline-C, Vuepoint II OCT

Primary outcome

Complications of Posterior Fixation System
Time frame: 24 months
Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system.
Radiographic Success
Time frame: 24 months
The proportion of subjects with apparent radiographic success at: 1. Latest timepoint available for patients undergoing surgery to treat advanced stage tumors 2. 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease

7 secondary outcomes

Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).
Time frame: 24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index.
Time frame: 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.
Time frame: 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).
Time frame: 24 months
Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index.
Time frame: 24 months
Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline measured by overall physical and mental health from PROMIS-10.
Time frame: 24 months
Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies
Time frame: 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Degenerative Disc Disease

Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Kyle Malone, MS study director

NuVasive

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease and Craniocervical Injuries, run by NuVasive at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complications of Posterior Fixation System (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04770571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.