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New titanium device shows promise for painful spine fractures

NCT ID NCT07242677

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a titanium implant called SPHEREPLAST in 37 people with spine fractures caused by osteoporosis or injury. The implant is placed during a procedure called balloon kyphoplasty to stabilize the broken bone and help it heal. Researchers looked at pain levels, disability, and X-ray results over one year. The goal was to see if the device is a safe and effective alternative to bone cement.

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

37 people

The number who actually took part.

Started

Feb 2026

Finished

Apr 2026

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

These are men and women over the age of 18 treated with SPHEREPLAST for post-traumatic and osteoporotic thoracolumbar vertebral compression fracture

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: * Patients treated with SPHEREPLAST for post-traumatic thoracolumbar VCFs A1 and A3, osteoporotic OF2 and OF3; * Complete availability of X-rays/MRI/CT scans; * Painful vertebral fracture with bone oedema on MRI and at least NRS \>4 units; * At least 12 months of follow-up. Exclusion Criteria: * VCF associated with metastatic lesions and myeloma; * Neurological impairment with compression of the spinal cord or nerves; * General contraindications to surgery.

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Conditions

The condition(s) this trial relates to.

Osteoporotic Fractures spinal fracture

As listed by the trial registrant

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

Contacts and locations

Locations

  • G. Rodolico - San Marco University Hospital, Via S. Sofia, 78

    Catania, Connecticut, Italy

More trials for these conditions

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