Intra-facet ION 3D Facet Screw SystemFixatIONNCT06720948
The ION Facet Screw System Ambispective Evaluation
An observational study of Intra-facet ION 3D Facet Screw System, run by SurGenTec LLC at 3 sites in United States.
Trial summary
The purpose of this observational, multi-center, ambispective, serial case study is to collect real-world patient outcomes that characterize the long-term safety and effectiveness of the SurGenTec ION 3D® Facet Screw System in a cervical spine and a lumbar spine application. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Intra-facet ION 3D Facet Screw System
- What is being tested?
- ION 3D Facet Screw System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2025to Dec 2026
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients that have previously undergone a cervical or lumbar facet fusion with the ION® Facet Screw System (IFSS) * Patients must be a minimum of one year postoperative
Who may be able to join
- Previously implanted intra-facet with one ION® Facet Screw placed per joint bilaterally at one or more contiguous levels of the cervical spine (C3-C7), or one or more contiguous levels of the lumbar spine (L3-S1),
- Must have supplemental fixation at the target level(s),
- Skeletally mature (minimum age of 21 years but not greater than 80 years),
- Be willing and able to comply with the study protocol requirements, and
- Be willing to sign the study-specific Informed Consent Document.
Who cannot join
- Implanted with the ION Facet Screw System at a spinal level that includes the thoracic spine (T1-T12),
- Unilateral fixation with the ION Fact Screw System,
- Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period,
- Significant metabolic bone disease (diagnosis of osteoporosis or osteomalacia),
- Currently taking medications that are known to potentially interfere with bone healing (e.g. chronic oral/systemic steroids),
- Pregnant or nursing female, or
- Incarcerated at the time of the required 12-month evaluation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Orthopaedics Northeast
Fort Wayne, Indiana, 46825
Neuroscience Specialists
Oklahoma City, Oklahoma, 73134
Shannon Clinic
San Angelo, Texas, 76903
About this study
Official title: An Observational Multicenter Consecutive Case Study of Long-Term Safety and Effectiveness Outcomes of a Real-World Population
The purpose of this observational, multi-center, ambispective, serial case study is to collect real-world patient outcomes that characterize the long-term safety and effectiveness of the SurGenTec ION 3D® Facet Screw System in a cervical spine and a lumbar spine application.
Read the detailed description
The statistical analysis of the data obtained from this study will be performed using a validated statistical software program such as SPSS®. All tests will be performed at the 0.05 significance level, unless otherwise specified. Analysis will be based upon the treated population defined as all subjects that underwent standard of care surgical intervention with the SurGenTec ION 3D Facet Screw System that agreed to participate in this data collection initiative.
Data collected in this study will be documented using summary tables and subject data listings. Continuous variables will be summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum, and maximum, and a 95% confidence interval for the mean based on the t-distribution. Categorical variables will be summarized using frequencies, percentages, and 95% confidence intervals for the true proportions. Resultant of the observational study design, this evaluation is not powered to test a hypothesis. It is designed to yield supplemental long-term information in this real-world population.
The analysis will be stratified by lumbar and cervical patients. Additionally, each cohort will evaluate the following analysis populations:
Enrolled Population: This dataset will include all subjects who were screened and enrolled into the study.
Evaluable Population: This dataset will exclude subjects with ION 3D Facet Screw device improperly placed
To minimize the introduction of bias into this observational low risk evaluation, the following measures will be observed:
- Complete and accurate prespecified data shall be obtained,
- All cervical and all lumbar patients at a study site that were previously implanted with the ION 3D Facet Screw System will be reviewed for possible study inclusion (all-comers study design),
- All participants will be enrolled under the same study entrance criteria,
- All participants shall follow the same prospectively designed study protocol,
- Serious Adverse Event adjudication will be performed by independent blinded reviewer, and
- Radiographic measurements and CT assessments will be performed by blinded independent core lab.
In consideration of the retrospective nature of this investigation coupled with a possible 1-time prospective evaluation, data monitoring will not be performed. However, data edits and database checks will be built into the EDC system to minimize the potential for data entry errors. Further, TSN, as the entity responsible for overall study conduct/management, will review all data entered and ensure appropriate source documentation is available to support data extraction/collection.
- Conditions
- Intra-facet ION 3D Facet Screw System
- Being tested
- ION 3D Facet Screw System
- Keywords
- ION, fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ION 3D Facet Screw SystemDevice
Observational study of subjects previously implanted with ION 3D Facet Screw System.
| Study group | Role | What they receive |
|---|---|---|
| Cervical | Previously implanted bilaterally intra-facet with the SurGenTec ION 3D Facet Screw System at one or two contiguous levels of the cervical spine (C3-C7) Receives: Device: ION 3D Facet Screw System | |
| Lumbar | Previously implanted bilaterally intra-facet with the SurGenTec ION 3D Facet Screw System at one or two contiguous levels of the lumbar spine (L3-S1) Receives: Device: ION 3D Facet Screw System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Quantitative Fusion
Defined as <5 degrees of angulation and/or <3mm translation as measured on dynamic flexion and extension radiographs
Measured: 12 Months Post-Op
Rate of Stability of operative level(s)
Substantial motion defined as >5 degrees angulation and/or >3mm translation as measured on dynamic flexion and extension radiographs.
Measured: 12 Months Post-Op
Rate of Qualitative Fusion
Bridging bone present external to the ION 3D facet screw device as observed on CT scan.
Measured: 12 Months Post-Op
Incidence of Serious Adverse Events
Freedom from ION 3D facet screw device-related serious adverse events as adjudicate by an independent reviewer.
Measured: 12 Months Post-Op
Incidence of Secondary Surgical Events
Secondary surgical events at the operative level(s) from intraoperative through ≥12-month evaluation timepoint.
Measured: 12 Months Post-Op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-facet ION 3D Facet Screw SystemStudies 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
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SurGenTec LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720948
- Sponsor's protocol ID
- TSN-2024-001
- Other IDs
- ION Facet RWE Study
- Acronym
- FixatION
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Multicenter Consecutive Case Study of Long-Term Safety and Effectiveness Outcomes of a Real-World Population
- ClinicalTrials.gov ID
- NCT06720948
- Acronym / sponsor ID
- FixatION / TSN-2024-001
- Conditions
- Intra-facet ION 3D Facet Screw System
- Keywords
- ION, fixation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SurGenTec LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Dec 2024 (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.
The purpose of this observational, multi-center, ambispective, serial case study is to collect real-world patient outcomes that characterize the long-term safety and effectiveness of the SurGenTec ION 3D® Facet Screw System in a cervical spine and a lumbar spine application.
Detailed description
The statistical analysis of the data obtained from this study will be performed using a validated statistical software program such as SPSS®. All tests will be performed at the 0.05 significance level, unless otherwise specified. Analysis will be based upon the treated population defined as all subjects that underwent standard of care surgical intervention with the SurGenTec ION 3D Facet Screw System that agreed to participate in this data collection initiative.
Data collected in this study will be documented using summary tables and subject data listings. Continuous variables will be summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum, and maximum, and a 95% confidence interval for the mean based on the t-distribution. Categorical variables will be summarized using frequencies, percentages, and 95% confidence intervals for the true proportions. Resultant of the observational study design, this evaluation is not powered to test a hypothesis. It is designed to yield supplemental long-term information in this real-world population.
The analysis will be stratified by lumbar and cervical patients. Additionally, each cohort will evaluate the following analysis populations:
Enrolled Population: This dataset will include all subjects who were screened and enrolled into the study.
Evaluable Population: This dataset will exclude subjects with ION 3D Facet Screw device improperly placed
To minimize the introduction of bias into this observational low risk evaluation, the following measures will be observed:
- Complete and accurate prespecified data shall be obtained,
- All cervical and all lumbar patients at a study site that were previously implanted with the ION 3D Facet Screw System will be reviewed for possible study inclusion (all-comers study design),
- All participants will be enrolled under the same study entrance criteria,
- All participants shall follow the same prospectively designed study protocol,
- Serious Adverse Event adjudication will be performed by independent blinded reviewer, and
- Radiographic measurements and CT assessments will be performed by blinded independent core lab.
In consideration of the retrospective nature of this investigation coupled with a possible 1-time prospective evaluation, data monitoring will not be performed. However, data edits and database checks will be built into the EDC system to minimize the potential for data entry errors. Further, TSN, as the entity responsible for overall study conduct/management, will review all data entered and ensure appropriate source documentation is available to support data extraction/collection.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical | – | Device: ION 3D Facet Screw SystemPreviously implanted bilaterally intra-facet with the SurGenTec ION 3D Facet Screw System at one or two contiguous levels of the cervical spine (C3-C7) |
| Lumbar | – | Device: ION 3D Facet Screw SystemPreviously implanted bilaterally intra-facet with the SurGenTec ION 3D Facet Screw System at one or two contiguous levels of the lumbar spine (L3-S1) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients that have previously undergone a cervical or lumbar facet fusion with the ION® Facet Screw System (IFSS) * Patients must be a minimum of one year postoperative
Key inclusion criteria (5 listed)
- Previously implanted intra-facet with one ION® Facet Screw placed per joint bilaterally at one or more contiguous levels of the cervical spine (C3-C7), or one or more contiguous levels of the lumbar spine (L3-S1),
- Must have supplemental fixation at the target level(s),
- Skeletally mature (minimum age of 21 years but not greater than 80 years),
- Be willing and able to comply with the study protocol requirements, and
- Be willing to sign the study-specific Informed Consent Document.
Key exclusion criteria (7 listed)
- Implanted with the ION Facet Screw System at a spinal level that includes the thoracic spine (T1-T12),
- Unilateral fixation with the ION Fact Screw System,
- Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period,
- Significant metabolic bone disease (diagnosis of osteoporosis or osteomalacia),
- Currently taking medications that are known to potentially interfere with bone healing (e.g. chronic oral/systemic steroids),
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 |
|---|---|---|
| ION 3D Facet Screw SystemObservational study of subjects previously implanted with ION 3D Facet Screw System. | Device | Cervical, Lumbar |
Primary outcome
Rate of Quantitative Fusion
Time frame: 12 Months Post-Op
Defined as <5 degrees of angulation and/or <3mm translation as measured on dynamic flexion and extension radiographs
Rate of Stability of operative level(s)
Time frame: 12 Months Post-Op
Substantial motion defined as >5 degrees angulation and/or >3mm translation as measured on dynamic flexion and extension radiographs.
Rate of Qualitative Fusion
Time frame: 12 Months Post-Op
Bridging bone present external to the ION 3D facet screw device as observed on CT scan.
Incidence of Serious Adverse Events
Time frame: 12 Months Post-Op
Freedom from ION 3D facet screw device-related serious adverse events as adjudicate by an independent reviewer.
Incidence of Secondary Surgical Events
Time frame: 12 Months Post-Op
Secondary surgical events at the operative level(s) from intraoperative through ≥12-month evaluation timepoint.
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 24 Aug 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-facet ION 3D Facet Screw System, run by SurGenTec LLC at 3 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 5 inclusion and 7 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Rate of Quantitative Fusion (time frame: 12 Months Post-Op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.