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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporotic Fractures; Vertebra Compression Fracture

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Italy
  • Connecticut
    • Catania, Connecticut, Italy
      • G. Rodolico - San Marco University Hospital, Via S. Sofia, 78

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	vertebral body height (VBH) in the anterior, middle and posterior projections	baseline, immediate post-operative and 1-year follow-up

Collaborators and Investigators

• Sponsor: MT Ortho s.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Actual): April 22, 2026
• Study Completion (Actual): April 22, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Osteoporotic Fractures
• Other Study ID Numbers: CSMT-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No