Clinical trial NCT02575352: Calcium Phosphate Cement Registry (CPC 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Disease
Fracture Bone
Bone Cyst
Keywords: Bone Substitute
Calcium Phosphate Cement
GRAFTYS
GRAFTYS®HBS
GRAFTYS®QUICKSET
Bone void filler
Bone growth
Registry
Bone defect
Revision arthroplasty
Arthrodesis
Lead sponsor: Graftys SA
Sponsor class: INDUSTRY
Collaborators: name: Clinfile
First posted: 2015-10-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients eligible and planned for bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of GRAFTYS®HBS/ GRAFTYS®Quickset.

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 description: 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.

Eligibility criteria: Inclusion Criteria:

1. Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized
2. Bone defects from surgery, trauma, tumor or cyst
3. Age ≥ 18 years
4. Patient information and signed informed consent form (for data collection)
5. Affiliation to a Social Security System schema (or similar system)

Exclusion Criteria:

1. Patients undergoing radiotherapy or chemotherapy
2. Patients with inflammatory bone disease
3. Patients with a calcium metabolism anomaly, severe metabolic disease, vascular or neurological diseases, or immunological deficiencies
4. Bone site which can lead to the product passing into the joint cavities without appropriate controls (visual, arthroscopic, lavage...).
5. Bone site which can lead to the product passing into the meningeal spaces
6. Vertebroplasty and kyphoplasty
7. Site infected or one suspected of being so
8. A cranio-maxillofacial defect with a surface area larger than 25 cm2
9. A site exposed to the sinus (lumen) or nasal mucosa
10. Pregnant women (or likely to be) or breast-feeding women
11. Inability to understand the consent and objectives of the study
12. Unable to undergo medical monitoring for geographical, social or psychological reasons
13. Persons who are deprived of liberty or under guardianship

Primary outcomes:
measure: Adverse Device Effect rate
timeFrame: For 24 months
Secondary outcomes:
measure: Technical Success rate
timeFrame: At surgical procedure
measure: Device Deficiencies rate
timeFrame: At surgical procedure
measure: Serious Adverse Events rate in the peroperative period
timeFrame: At surgical procedure
measure: Serious Adverse Events rate during the follow-up period
timeFrame: 3 months post index procedure
measure: Serious Adverse Events rate during the follow-up period
timeFrame: 6 months post index procedure
measure: Serious Adverse Events rate during the follow-up period
timeFrame: 9 months post index procedure
measure: Serious Adverse Events rate during the follow-up period
timeFrame: 12 months post index procedure
measure: Serious Adverse Events rate during the follow-up period
timeFrame: 24 months post index procedure
measure: Bone reconstruction evolution after surgery (if X-rays are available)
timeFrame: 3 months post index procedure
measure: Bone reconstruction evolution after surgery (if X-rays are available)
timeFrame: 6 months post index procedure
measure: Bone reconstruction evolution after surgery (if X-rays are available)
timeFrame: 9 months post index procedure
measure: Bone reconstruction evolution after surgery (if X-rays are available)
timeFrame: 12 months post index procedure
measure: Bone reconstruction evolution after surgery (if X-rays are available)
timeFrame: 24 months post index procedure
measure: Quality of life score at baseline (EQ-5D-3L)
timeFrame: At baseline (pre-operative)
measure: Quality of life score evolution after surgery (EQ-5D-3L)
timeFrame: 3 months post index procedure
measure: Quality of life score evolution after surgery (EQ-5D-3L)
timeFrame: 6 months post index procedure
measure: Quality of life score evolution after surgery (EQ-5D-3L)
timeFrame: 9 months post index procedure
measure: Quality of life score evolution after surgery (EQ-5D-3L)
timeFrame: 12 months post index procedure
measure: Quality of life score evolution after surgery (EQ-5D-3L)
timeFrame: 24 months post index procedure
measure: Functional score at baseline (if applicable according to the type of bone defect/medical indication).
timeFrame: At baseline (pre-operative)
measure: Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).
timeFrame: 3 months post index procedure
measure: Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).
timeFrame: 6 months post index procedure
measure: Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).
timeFrame: 9 months post index procedure
measure: Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).
timeFrame: 12 months post index procedure
measure: Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).
timeFrame: 24 months post index procedure
measure: Surgeon's Satisfaction survey with registry device
timeFrame: At surgical procedure
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital La Timone
city: Marseille
country: France
city: Paris
country: France
city: Saint-louis
country: France
city: Kiel
country: Germany
city: Ratzeburg
country: Germany
city: Würzburg
country: Germany
city: Palermo
country: Italy
city: Piacenza
country: Italy
city: Fort-de-France
country: Martinique
city: Yverdon-les-bains
country: Switzerland
Study officials:
affiliation: Hospital of "LA TIMONE"
name: Sébastien PARRATTE, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: