Clinical Trial: Calcium Phosphate Cement Registry (CPC Registry)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.

Brief Summary: 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).

Detailed Summary:

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
Sponsor: Graftys SA

Current Primary Outcome: Adverse Device Effect rate [ Time Frame: For 24 months ]

Rate of Adverse Events related to bone substitutes (registry devices) for the follow-up period of patients.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technical Success rate [ Time Frame: At surgical procedure ]
    Technical Success rate defined as successful delivery of the bone substitute in the target defect bone without evidence of delivery device or bone substitute malfunction. (NOTE: Malfunction is definied as a failure of the medical device to perform in accordance with its intended purpose when used in accordance with the Instructions For Uses (IFU)).
  • Device Deficiencies rate [ Time Frame: At surgical procedure ]

    Device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.

    NOTE: Device deficiencies include malfunctions, use errors, and inadequate labelling.

  • Serious Adverse Events rate in the peroperative period [ Time Frame: At surgical procedure ]

    Serious Adverse Event is defined as any adverse event that:

    1. Led to a death,

    2. Led to serious deterioration in health of the subject that either resulted in:

      1. a life-threatening illness or injury, or
      2. a permanent impairment of a body structure or a body function, or
      3. in-patient or prolonged hospitalization, or
      4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.
    3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.
  • Serious Adverse Events rate during the follow-up period [ Time Frame: 3 months post index procedure ]

    Serious Adverse Event is defined as any adverse event that:

    1. Led to a death,

    2. Led to serious deterioration in health of the subject that either resulted in:

      1. a life-threatening illness or injury, or
      2. a permanent impairment of a body structure or a body function, or
      3. in-patient or prolonged hospitalization, or
      4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.
    3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.
  • Serious Adverse Events rate during the follow-up period [ Time Frame: 6 months post index procedure ]

    Serious Adverse Event is defined as any adverse event that:

    1. Led to a death,

    2. Led to serious deterioration in health of the subject that either resulted in:

      1. a life-threatening illness or injury, or
      2. a permanent impairment of a body structure or a body function, or
      3. in-patient or prolonged hospitalization, or
      4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.
    3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.
  • Serious Adverse Events rate during the follow-up period [ Time Frame: 9 months post index procedure ]

    Serious Adverse Event is defined as any adverse event that:

    1. Led to a death,

    2. Led to serious deterioration in health of the subject that either resulted in:

      1. a life-threatening illness or injury, or
      2. a permanent impairment of a body structure or a body function, or
      3. in-patient or prolonged hospitalization, or
      4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.
    3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.
  • Serious Adverse Events rate during the follow-up period [ Time Frame: 12 months post index procedure ]
    Same as current

    Information By: Graftys SA

    Dates:
    Date Received: October 12, 2015
    Date Started: May 2015
    Date Completion: May 2019
    Last Updated: August 9, 2016
    Last Verified: August 2016