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NCT Number: NCT07242677

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

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.

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Key information

Conditions

Vertebra Compression Fracture Fractures, Bone Osteoporotic Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Catania, Connecticut, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. NRS (Numerical Rating Scale)

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

  2. ODI (Oswestry Disability Index)

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

Secondary outcomes

  1. adverse events (AEs), serious adverse events (SAEs) and adverse device events (ADEs)

    Time frame: postoperatively, at 1 month and at 1 year

  2. NRS (Numerical Rating Scale)

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

  3. Kyphotic Angle (KA)

    Time frame: post-operative and 1-year follow-up

  4. Wedge Angle (WA)

    Time frame: post-operative and 1-year follow-up

  5. vertebral body height (VBH)

    Time frame: baseline, immediate post-operative and 1-year follow-up

    vertebral body height (VBH) in the anterior, middle and posterior projections

Sponsors and collaborators

Lead sponsor

MT Ortho s.r.l.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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