Post-market Observational Clinical Study With the Medical Device 'SPHEREPLAST'
NCT ID: NCT07242677
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-12-01
2026-01-31
Brief Summary
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SPHEREPLAST is a titanium alloy (Ti6Al4V-ELI) trabecular sphere system designed to stabilise the vertebral body structure after balloon kyphoplasty, providing immediate mechanical stability and promoting bone ingrowth.
The study includes 40 adult patients who have been treated with SPHEREPLAST for thoracolumbar VCFs (A1, A3, OF2, OF3). Data will be collected retrospectively from medical records at four timepoints: pre-operative (baseline), within five days after surgery, at one month, and at one year post-surgery.
The primary endpoints are the changes in pain intensity (Numerical Rating Scale, NRS) and disability (Oswestry Disability Index, ODI) between baseline and 1-year follow-up. Secondary endpoints include radiographic outcomes (kyphotic angle, wedge angle, vertebral body height) and the incidence of adverse events related to the device or the procedure.
The aim of the study is to assess the real-world clinical efficacy and safety of SPHEREPLAST as an alternative to bone cement in kyphoplasty, with specific attention to pain control, functional recovery, and vertebral stability.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Neurological impairment with compression of the spinal cord or nerves;
* General contraindications to surgery.
18 Years
ALL
No
Sponsors
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MT Ortho s.r.l.
INDUSTRY
Responsible Party
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Locations
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G. Rodolico - San Marco University Hospital, Via S. Sofia, 78
Catania, CT, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSMT-004
Identifier Type: -
Identifier Source: org_study_id
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