Graftys’ calcium phosphate injectable cement (both Graftys® QuickSet and Graftys® HBS) are class III medical devices. According to European Guidelines on Medical Devices MEDDEV 2.12/2, and European Council Directive 2007/47/EC, all medical devices of this class are required to have evidence of a post-market clinical follow-up (PMCF) study protocol, also known as Clinical Investigation. The objective of a clinical investigation is to assess both the safety and clinical performance of the device in question and evaluate whether the device is suitable for the purpose and the population for which it is intended when used in accordance with its approved labelling.
In compliance with regulations, Graftys has launched on May 2015 “CPC Registry”, an observational prospective international study that aims to collect real-life data of Graftys calcium phosphate injectable cements range in routine clinical practice. Today, the study is running in France, Germany, Italy, Switzerland; and more European investigation sites are planned to be included.
CPC registry will contribute to enhancing the scientific literature on the use of CaP cement, as well as to building a scientific working group that will be able to map real needs of the field in order to improve products online with their practices, based on the outcome of the study.
Study planned milestones:
First patient In: May 2015
Last Patient In: May 2019
Last patient out/completed: May 2021
Number of patients: 20/center
Patient follow-up period: 5 follow- up visits/calls over 2 years (at 3, 6,9,12, and 24 months)
For more details, please refer to the following website: clinicaltrial.gov
ClinicalTrials.gov Identifier n°: NCT02575352
Investigator Initiated Studies (IIS)
This part is under construction, more information will be available soon.