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Spine screw system under Long-Term review

NCT ID NCT06720948

Knowledge-focused Sponsor: SurGenTec LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study follows 50 people who already have the ION 3D Facet Screw System implanted in their spine. Researchers will check how well the bones fuse and if any serious side effects occur over at least 12 months. The goal is to see if the device is safe and works well in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ION 3D Facet Screw System (a medical device used to stabilize spine bones)
What this could lead to
If successful, this study could confirm that the ION 3D Facet Screw System is safe and effective for long-term spine stabilization.
What could go wrong
This is an observational study with only 50 participants, so results may not apply to everyone. It does not test a new treatment, just collects existing data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

* 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

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intra-facet ion 3D facet screw system

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Neuroscience Specialists

    Oklahoma City, Oklahoma, 73134, United States

  • Orthopaedics Northeast

    Fort Wayne, Indiana, 46825, United States

  • Shannon Clinic

    San Angelo, Texas, 76903, United States