Bone Disease Clinical Trial
Official title:
Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.
CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults. All patients will be treated with any of the two injectable calcium phosphate bone substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard clinical practice and according to the information provided by GRAFTYS manufacturer in respective device Instructions For Use (IFU).
The objective of this observational prospective study is to collect safety and performance
data relating to the use of injectable Calcium Phosphate Cements
"GRAFTYS®HBS/GRAFTYS®Quickset (or their private labels)" in routine clinical practice from
various international hospitals. Therefore this observational study will allow to support
data about risk management (established at the end of the product development); and to
enhance the current clinical evaluation of products with new clinical data (for longer
follow-up). The collected data of this observational study will be "non-identifying data".
The patient must have signed a Written Consent Form (for data collection) prior to any data
being entered into the electronic Case Report Form.
Patients will be followed as per local standard medical practices of the center for two
years. Five follow-up visits/phone calls will be collected (at 3 months (+/-14 days), 6
months (+/- 14 days), 9 months (+/-21 days), 12 months (+/- 30 days) and 24 months (+/-60
days)). Each visit/phone call includes the collection of Adverse Events, the measurement of
health status (quality of life and functional scores) and the X-ray scoring (if X-ray imaging
is available). No additional exams (other than the routine clinical practice) are requested.
The surgeons have to follow their usual practices (e.g. X-Rays have to be performed only if
they are scheduled in the routine clinical practice).
All Adverse Events will be collected and monitored at each follow-up visit or follow-up phone
call. All Serious Adverse Events must be described via a Serious Adverse Event form in e-CRF
and all Adverse Device Effects must be described via a "Product Complaint Form" in e-CRF.
Descriptive analyses will be performed in order to describe: nature of adverse events, their
distribution and frequency. Moreover, all factors which may appear predictive for the rate of
adverse events will be analyzed (age, sex, amount of CPC injected, delivery system used,
diabetes history, smoking habits, alcohol consumption, concomitant treatments/diseases…). For
all time-dependent events, life-tables will be able to calculate using the Kaplan Meier
estimate method, for a period starting on the date of the procedure up to and including the
24-months follow-up visit.
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