Vertebra Compression FractureNCT07242677
Post-market Observational Clinical Study With the Medical Device 'SPHEREPLAST'
An observational study of Vertebra Compression Fracture and Osteoporotic Fractures, run by MT Ortho s.r.l. at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebra Compression Fracture, Osteoporotic Fractures
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2026to 22 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: These are men and women over the age of 18 treated with SPHEREPLAST for post-traumatic and osteoporotic thoracolumbar vertebral compression fracture
Who may be able to join
- 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.
Who cannot join
- VCF associated with metastatic lesions and myeloma;
- Neurological impairment with compression of the spinal cord or nerves;
- General contraindications to surgery.
Trial locations and contacts
1 site in 1 country.
Italy1 site
G. Rodolico - San Marco University Hospital, Via S. Sofia, 78
Catania, Connecticut
About this study
Official title: 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.
Read more
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.
- Medical subject headings
- Osteoporotic Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (Numerical Rating Scale)
Measured: between baseline (pre-operative) and 1-year follow-up
ODI (Oswestry Disability Index)
Measured: between baseline (pre-operative) and 1-year follow-up
Secondary outcomes (5)
adverse events (AEs), serious adverse events (SAEs) and adverse device events (ADEs)
Measured: postoperatively, at 1 month and at 1 year
NRS (Numerical Rating Scale)
Measured: baseline (pre-operative) and immediate post-operative and 1-month follow-ups
Kyphotic Angle (KA)
Measured: post-operative and 1-year follow-up
Wedge Angle (WA)
Measured: post-operative and 1-year follow-up
vertebral body height (VBH)
vertebral body height (VBH) in the anterior, middle and posterior projections
Measured: baseline, immediate post-operative and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start3 Feb 2026
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebra Compression FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- MT Ortho s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242677
- Sponsor's protocol ID
- CSMT-004
- Status last verified
- May 2026
- First submitted
- 17 Nov 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Observational Clinical Study With the Medical Device 'SPHEREPLAST' (SPHERE Study)
- ClinicalTrials.gov ID
- NCT07242677
- Acronym / sponsor ID
- CSMT-004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- MT Ortho s.r.l.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These are men and women over the age of 18 treated with SPHEREPLAST for post-traumatic and osteoporotic thoracolumbar vertebral compression fracture
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- VCF associated with metastatic lesions and myeloma;
- Neurological impairment with compression of the spinal cord or nerves;
- General contraindications to surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NRS (Numerical Rating Scale)
Time frame: between baseline (pre-operative) and 1-year follow-up
ODI (Oswestry Disability Index)
Time frame: between baseline (pre-operative) and 1-year follow-up
5 secondary outcomes
adverse events (AEs), serious adverse events (SAEs) and adverse device events (ADEs)
Time frame: postoperatively, at 1 month and at 1 year
NRS (Numerical Rating Scale)
Time frame: baseline (pre-operative) and immediate post-operative and 1-month follow-ups
Kyphotic Angle (KA)
Time frame: post-operative and 1-year follow-up
Wedge Angle (WA)
Time frame: post-operative and 1-year follow-up
vertebral body height (VBH)
Time frame: baseline, immediate post-operative and 1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebra Compression Fracture and Osteoporotic Fractures, run by MT Ortho s.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (Numerical Rating Scale) (time frame: between baseline (pre-operative) and 1-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.