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Spine surgery device under review: does karma fixation deliver?

NCT ID NCT07207187

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is gathering information from 100 people who have already had spine surgery using the Karma Fixation System. Researchers want to see how well the bones fuse together and if patients have less pain and disability. The goal is to understand how effective this system is in real-world use.

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 100 people

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

Started

Mar 2025

Expected to finish

Jan 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

Study will include a maximum of 10 US sites.

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: * Skeletally mature and age ≥ 18 years of age at the time of surgery * Previously treated with the Karma Fixation System * Has at least 12-months post-surgery imaging obtained including a minimum 2 view x-rays (lateral flexion and lateral extension) and CT scan, or willing to return to obtain imaging * Be willing and able to comply with the study protocol requirements * Be willing to sign the study-specific Informed Consent Document Exclusion Criteria: * Previous fusion or total disc replacement at the index level(s) * Active systemic infection at the index level at the time of surgery * Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period * Diagnosis of osteomalacia or Paget's bone disease * Currently enrolled in a competing research study * Currently incarcerated \\ * Currently pregnant or plans to become pregnant

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As listed by the trial registrant

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

Subjects treated with karma fixation system as part of their spine surgery

How to take part

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

  1. The places running it

    4 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

  • Ascension St. Vincent's

    Jacksonville, Florida, 32259, United States

  • Neuroscience Specialist

    Oklahoma City, Oklahoma, 73134, United States

  • Sonoran Spine

    Gilbert, Arizona, 85297, United States

  • The Spine Institute of Louisiana

    Shreveport, Louisiana, 71101, United States