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Spine surgery tool tested for better alignment

NCT ID NCT07023393

Knowledge-focused Sponsor: Duke University 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study was designed to test a new tool that helps surgeons measure and adjust the spine during fusion surgery. The goal was to see if using the tool leads to better spinal alignment and improved patient outcomes, such as less disability. However, the study was withdrawn before any participants were enrolled, so no results are available.

What this could mean

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

Active substance
Intraoperative spinal measurement system (Paradigm TM System by Proprio)
What this could lead to
If it had worked, this tool could help surgeons better align the spine during fusion surgery, potentially leading to fewer repeat surgeries and better recovery.
What could go wrong
The study was withdrawn before enrolling anyone, so no data was collected. Even if tested, the tool might not improve outcomes or could have technical limitations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Adult patients aged 18 years or older at the time of surgery * Type of Surgery: Consecutively scheduled patients where the measurement system will be used who will have thoracolumbosacral posterior spine surgery that includes spinal instrumentation and fusion and that consent to the study Exclusion Criteria: * Patients treated for traumatic injury (penetrating injuries, etc.) * Incarcerated persons * Pregnant females * Any patient current in another trial for a new implant or technique * Non-Spine Related Surgeries: Patients who had surgeries for reasons other than spine-related conditions (even if they incidentally involved the spine) * Patients having additional surgery occurring concurrently with spine surgery * Patients ineligible for surgery

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Conditions

The condition(s) this trial relates to.

Intervertebral Disc Displacement intervertebral disk degenerative disorder Scheuermann disease Spinal Curvatures Spinal Osteochondrosis Spinal Osteophytosis spinal stenosis spondylitis spondylosis vertebral column disorder

As listed by the trial registrant

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

Intervertebral disc degeneration Intervertebral disc displacement Spinal curvatures Spinal osteochondrosis Spinal osteophytosis Spinal stenosis Spondylitis Spondylosis

Contacts and locations

Locations

  • Duke University Health System

    Durham, North Carolina, 27710, United States

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