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

U.S., Nov. 22 -- ClinicalTrials.gov registry received information related to the study (NCT07242677) titled 'Post-market Observational Clinical Study With the Medical Device 'SPHEREPLAST'' on Nov. 17.

Brief 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...