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

MT Ortho s.r.l.

Status: Not yet enrolling

Conditions: Osteoporotic Fractures; Vertebra Compression Fracture

Study type: Observational

Funder types: Industry

Identifiers

NCT07242677

CSMT-004

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.