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

NCT07242677 | Not Yet Recruiting

• 1 other identifier: CSMT-004
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (2)

• NRS (Numerical Rating Scale)

  between baseline (pre-operative) and 1-year follow-up

• ODI (Oswestry Disability Index)

  between baseline (pre-operative) and 1-year follow-up

Secondary Outcomes (5)

• adverse events (AEs), serious adverse events (SAEs) and adverse device events (ADEs)

  postoperatively, at 1 month and at 1 year

• NRS (Numerical Rating Scale)

  baseline (pre-operative) and immediate post-operative and 1-month follow-ups

• Kyphotic Angle (KA)

  post-operative and 1-year follow-up

• Wedge Angle (WA)

  post-operative and 1-year follow-up

• vertebral body height (VBH)

  baseline, immediate post-operative and 1-year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

These are men and women over the age of 18 treated with SPHEREPLAST for post-traumatic and osteoporotic thoracolumbar vertebral compression fracture

You may qualify if:

• 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.

You may not qualify if:

• VCF associated with metastatic lesions and myeloma;
• Neurological impairment with compression of the spinal cord or nerves;
• General contraindications to surgery.

Sponsors & Collaborators

• MT Ortho s.r.l.: lead

Study Sites (1)

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

Catania, CT, Italy

Location

MeSH Terms

Conditions

Osteoporotic Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Central Study Contacts

Rosalia Mineo

CONTACT

+393209540011; rosalia.mineo@mtortho.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

IT (1)