Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2015-05-31
2021-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Clinfile
INDUSTRY
Graftys SA
INDUSTRY
Responsible Party
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Principal Investigators
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Sébastien PARRATTE, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Hospital of "LA TIMONE"
Locations
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Hôpital La Timone
Marseille, , France
Marseille, , France
Paris, , France
Saint-Louis, , France
Kiel, , Germany
Ratzeburg, , Germany
Würzburg, , Germany
Palermo, , Italy
Piacenza, , Italy
Fort-de-France, , Martinique
Yverdon-les-Bains, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Sébastien PARRATTE, MD, Prof.
Role: primary
Other Identifiers
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GR-NI-INJ
Identifier Type: -
Identifier Source: org_study_id
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