Please sign in to follow a disease.
New titanium device shows promise for painful spine fractures
NCT ID NCT07242677
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Osteoporotic fractures are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
- Could a simple education program stop the cycle of fractures in the elderly?
- Spine procedure put to the test against sham for osteoporosis fracture pain
- Virtual fitness and nutrition program aims to keep older men on their feet
- New scoring system aims to help osteoporosis patients walk again faster after spine fractures
- New ultrasound scan could predict fracture risk without radiation
- New study aims to find best drug sequence to stop bone breaks