Kiphoplasty With Porous Titanium Microspheres for Treatment of Vertebral Osteoporotic Compression Fractures: Perspective Study on Efficacy and Safety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Disability index
Study Overview
Brief 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.
Detailed Description
The study is purely observational, sponsored, and does not involve any change in the diagnostic, therapeutic, and follow-up course of patients selected on a clinical basis for kyphoplasty with porous titanium microspheres. involved but only an analysis and comparison of data during normal clinical-surgical activity. The study aims to evaluate, in a prospective-observational setting, the benefit of this treatment on pain control and prevention of deformity following fracture. Kyphoplasty with porous titanium spheres has already been used successfully and without obvious safety issues.
No additional radiologic exposures are planned over and above those in the normal courses of care and follow-up. No additional diagnostic investigations are planned. The study ensures data collection with full respect for privacy. There are no conflicts of interest for any of the board members.
The effectiveness of the therapy used is tested by considering the ODI, MRQ, VAS score expressed in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity. The sample size is evaluated based on the primary objective of demonstrating a significant reduction in disability and pain after treatment in the range of 20%. With a significance of 0.05, a power of the test of 0.95, assuming to compare the two samples by t test for paired data the sample size can be in the order of 15 patients.
The evaluation of secondary end-points, which is not binding, will be carried out on similar sample numerosity.
All patients with the following requirements may be included in the observational study. The patient will be asked to give informed consent for inclusion in the study. Contextually, consent will be acquired for the processing of personal data in relation to the current privacy law. Consents must be acquired from the Investigating Surgeon performing the procedure in full respect of the Physician-Patient relationship. The informed consent will include acceptance of the follow-up period of at least 1 year with the possibility of telephone follow-up as well. The patient will also be given an information sheet regarding the purpose and type of the study and the expression of consent to participate. Attached is the informed consent form, patient information sheet and consent for personal data processing and privacy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Disability index
Time Frame: 1 year
Evaluation of the effectiveness of treatment on reducing disability secondary to the occurrence of osteoporotic compression fracture. The used scale is: Oswestry Disability Index (ODI) The effectiveness of the therapy used was tested by considering the ODI expressed (from 0 to 50) in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity.
Patients with Pain improvement
Time Frame: 1 year
Evaluation of the effectiveness of treatment on reducing pain after the treatment. The used scale is Back Pain Visual Analogue Scale (VAS) from 0 (no pain) to 10 (maximum pain). The effectiveness of the therapy used was tested by considering VAS scale expressed in numerical value before ("pre" condition) and after ("post" condition) kyphoplasty treatment as the observed quantity.
Secondary Outcomes
- Percentage of patients with side effects(1 year)
- Rate of Kyphosis recovery(3 months)
- Rate of patients with dislocation of the sphere(1 year)
Investigators
Fabio Cofano, MD
Principal investigator, Researcher, Neurosurgeon
Unit of neurosurgery, Departement of Neurosciences, University of Torino