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.