UnknownNot Applicable

Porous Titanium Microspheres in Kyphoplasty

Italy15 participantsStarted 2021-01-01

Plain-language summary

Study is a prospective observational, performed in the context of normal clinical practice, of patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres (see whether to put commercial name and company). The study does not involve any interference with the patient's diagnostic-therapeutic course The objective of the study is the clinical-radiological evaluation of the efficacy of kyphoplasty treatment with trabecular porous titanium spheres in terms of pain control and reduction of kyphotic deformity following fracture. Further evaluation of the safety of the treatment in terms of absence of intraoperative adverse events and material-related toxicity.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presence of osteoporotic vertebral fracture occurred within the previous 6 weeks and documented by CT, MRI, or X-ray in relation to the diagnostic pathway the patient underwent * Patients with fractures according to AO Spine-DGOU OF2, OF3 and OF4 classification are enrollable limited to cases in which soma height loss is less than 60% and in the absence of vertical split type pincer fracture. * Diagnosis of osteoporosis preceding or concurrent with fracture occurrence, regardless of current therapy * Favorable for inclusion in the study with signed informed consent, available for follow-up up to 1 year. * Availability of adequate preoperative radiologic documentation: CT or MRI of the lumbar spine; RX required for evaluation of kyphosis. * Availability of adequate and comprehensive clinical information including presence of ODI score, MRQ, VAS. Exclusion Criteria: * Presence of oncologic, metabolic, or endocrinologic diseases related to bone fragility * Age \< 55 years * Previous treatment of arthrodesis, vertebroplasty, or percutaneous kyphoplasty for previous fractures * Presence of neurological deficits in the lower limbs medullary or radicular prior to fracture occurrence * Unavailability for follow-up for at least 1 year

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disability index

Timeframe: 1 year

Patients with Pain improvement

Timeframe: 1 year

Trial details

NCT IDNCT05815251

SponsorUnit of neurosurgery, Departement of Neurosciences, University of Torino

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

Contact for this trial

Fulvio Tartara, M.D.

+39 3356847079 tartarafulvio@gmail.com

View on ClinicalTrials.gov More Vertebral Fracture trials