NCT07242677

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: MT Ortho s.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 procedures for the treatment of traumatic and osteoporotic vertebral compression fractures (VCFs). 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.

Conditions

• Vertebra Compression Fracture
• Osteoporotic Fractures

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: Italy