Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Adverse Device Effect rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized
- •Bone defects from surgery, trauma, tumor or cyst
- •Age ≥ 18 years
- •Patient information and signed informed consent form (for data collection)
- •Affiliation to a Social Security System schema (or similar system)
排除标准
- •Patients undergoing radiotherapy or chemotherapy
- •Patients with inflammatory bone disease
- •Patients with a calcium metabolism anomaly, severe metabolic disease, vascular or neurological diseases, or immunological deficiencies
- •Bone site which can lead to the product passing into the joint cavities without appropriate controls (visual, arthroscopic, lavage...).
- •Bone site which can lead to the product passing into the meningeal spaces
- •Vertebroplasty and kyphoplasty
- •Site infected or one suspected of being so
- •A cranio-maxillofacial defect with a surface area larger than 25 cm2
- •A site exposed to the sinus (lumen) or nasal mucosa
- •Pregnant women (or likely to be) or breast-feeding women
- •Inability to understand the consent and objectives of the study
- •Unable to undergo medical monitoring for geographical, social or psychological reasons
- •Persons who are deprived of liberty or under guardianship
结局指标
主要结局
Adverse Device Effect rate
时间窗: For 24 months
Rate of Adverse Events related to bone substitutes (registry devices) for the follow-up period of patients.
次要结局
- Device Deficiencies rate(At surgical procedure)
- Quality of life score at baseline (EQ-5D-3L)(At baseline (pre-operative))
- Quality of life score evolution after surgery (EQ-5D-3L)(24 months post index procedure)
- Technical Success rate(At surgical procedure)
- Serious Adverse Events rate during the follow-up period(24 months post index procedure)
- Bone reconstruction evolution after surgery (if X-rays are available)(24 months post index procedure)
- Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).(24 months post index procedure)
- Serious Adverse Events rate in the peroperative period(At surgical procedure)
- Functional score at baseline (if applicable according to the type of bone defect/medical indication).(At baseline (pre-operative))
- Surgeon's Satisfaction survey with registry device(At surgical procedure)