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COMPLETEDNCT07242677

Post-market Observational Clinical Study With the Medical Device 'SPHEREPLAST'

This is a retrospective, single-centre, single-arm post-market observational study evaluating the safety and clinical performance of the SPHEREPLAST medical device used in balloon kyphoplasty procedur...

Lead sponsor: MT Ortho s.r.l.•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

MT Ortho s.r.l.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 1, 2026Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment37

Start dateFeb 2026

Last updatedJun 1, 2026

Condition

Vertebra Compression Fracture Osteoporotic Fractures

Locations shown

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

Catania, Connecticut

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2026Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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