Porous Titanium Microspheres in Kyphoplasty

NCT ID: NCT05815251

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-12-31

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.

The procedure is performed under local anesthesia with the aid of possible sedation. Patient in prone position on radiolucent table with possibility of fluoroscopy in antero-posterior and latero-lateral projection. Biportal (bilateral) access with dedicated trokar to be placed in the anterior part of the fractured vertebral soma with convergent trajectory and transpeduncular access. Replacement of trokar with with larger cannula. Placement and dilatation of kyphoplasty balloon (15 ml volume) bilaterally. Introduction with dedicated instrument of porous titanium microspheres with possibility of using compactor to increase consistency of overall cast of material. Procedure performed with fluoroscopic control.

Data collection.

All data entered in the CRF data collection form must be collected for recruited patients:

• generality: age, sex, smoking habit, previous diagnosis of osteoporosis or new diagnosis of osteoporosis
• level and classification of fracture (AOSpine)
• operative data: date of surgery, type of access, number of spheres used, type of kyphoplasty pole, intraoperative adverse events, and technical difficulties
• clinical data: diagnosis, date of fracture, ODI, MRIQ, VAS back, days of postoperative hospital stay. For clinical and outcome assessment, point scales ODI score (Oswestry Disability Index) Roland-Morris Questionnaire, Back Pain Visual Analogue Scale (VAS) whose reliability is well reported in the literature (bibliographic entries) are used.
• Radiological data: segmental kyphosis, kyphosis of the fractured soma, possible progression of the fracture. Segmental kyphosis is calculated as Cobb angle, and changes (delta) pre-postoperative and at follow-up are reported.

Protection of privacy.

Data collection remains within the center promoting the research in the context of normal clinical activity and in compliance with current regulations. As reported, further consent to the processing of personal data is acquired. Radiological images will be obtained during the procedure and hospitalization will be archived regularly. Images performed externally in other hospitals or diagnostic centers will be acquired and stored, with the express consent of the patient, by the referring Investigating Surgeon. All images will eventually be used for scientific activities in a completely anonymous form.

All recruited patients should be followed, unless the patient explicitly withdraws consent, in follow-up for at least 1 year. the entire duration of the study initially planned to be 5 years. Follow-up evaluations will have to involve the acquisition of all data already indicated in section 4.4 to be entered in the data collection form (CRF-FU). The follow-up clinical evaluation will involve the acquisition of ODI, RMQ questionnaires in addition to VAS back at 1, 3 and 12 months.

Follow-up is the responsibility of the referring Investigating Surgeon in full respect of the Physician-Patient relationship and Privacy. A telephone evaluation may be performed on patients who are unavailable for outpatient evaluations or cannot be reached by administering ODI, RMQ and VAS back and interview.

Follow-up will also include the performance and acquisition of a lumbar spine X-ray performed in standing load at 1 month, 3 months and at 12 months as in the normal clinical course of patients undergoing percutaneous kyphoplasty procedures. Thus, patients are not subjected to additional examinations for participation in the study. Follow-up CT and MRI examinations will be performed eventually, as usual, only for supervening clinical reasons such as persistence of pain or appearance of new neurological deficits.

Participants in the study as investigators are all Surgeons with proven experience in spine surgery selected from within the medical team of the proposing center. Upon association of a Surgeon, a letter of intent in duplicate is required to be signed to emphasize the required commitment and the roles of the investigator.

Participating Investigating Surgeons may recruit patients in the context of their regular surgical practice. Recruitment should be prospective and the patient should be enrolled prior to kyphoplasty treatment in order to avoid selection bias related to the clinical outcome obtained.

Conditions

Vertebral Fracture; Kyphoplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sphereplast group

Patients with osteoporotic vertebral compression fractures identified as candidates for kyphoplasty treatment with porous trabecular titanium microspheres

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

Unit of neurosurgery, Departement of Neurosciences, University of Torino

OTHER

Sponsor Role: lead

Responsible Party

Fabio Cofano, MD

Principal investigator, Researcher, Neurosurgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università degli studi di Torino

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fulvio Tartara, M.D.

Role: CONTACT

tartarafulvio@gmail.com

+39 3356847079

Fabio Cofano, M.D.

Role: CONTACT

fabio.cofano@gmail.com

+39 33313441404

Facility Contacts

Fabio Cofano, M.D.

Role: primary

fabio.cofano@gmail.com

+39 3331341404

Diego Garbossa, Professor

Role: backup

diego.garbossa@unito.it

+39 3498739698

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Other Identifiers

Microsphere001

Identifier Type: -

Identifier Source: org_study_id