Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New implant aims to improve spinal fusion outcomes in pelvic surgery

NCT ID NCT05640908

Disease control Sponsor: SI-BONE, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 testing a device called iFuse Bedrock Granite in 200 adults having spinal fusion surgery that also involves fixing the pelvis. The goal is to see if the implant is safe, works well, and helps reduce pain and improve quality of life. Participants will be followed for up to 24 months to check for complications like implant breakage or loosening.

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 200 people

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

Started

Jun 2023

Expected to finish

Dec 2027

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 with spinal fusion including pelvic fixation/fusion using GRANITE

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: 1. ≥ 18 years of age at screening. 2. Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite 3. Patient is willing and able to provide written informed consent Exclusion Criteria: 1. Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s) 2. Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation 3. Known allergy to titanium or titanium alloys 4. Current local or systemic infection that raises the risk of surgery 5. Currently pregnant or planning pregnancy in the next 2 years 6. Known or suspected active drug or alcohol abuse, including opioids 7. Patient is a prisoner or ward of the state 8. Patient is enrolled in an investigational clinical trial related to the spine

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Deformity of spine are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

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

Deformity of spine Spinal fusion

Contacts and locations

Locations

  • Corewell Health

    Royal Oak, Michigan, 48073, United States

  • Northwell Health

    New York, New York, 10075, United States

  • Pinehurst Surgical Clinic

    Pinehurst, North Carolina, 28374, United States

  • Texas Back Institute

    Plano, Texas, 75093, United States

  • USA Neurosurgery

    Mobile, Alabama, 36688, United States

  • University at Buffalo

    Buffalo, New York, 14203, United States

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55454, United States

  • University of Texas Health, Houston

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.