Calcium Phosphate Cement Registry (CPC Registry)

Bone Disease Clinical Trial

— CPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02575352
• Other study ID #: GR-NI-INJ
• Status: Recruiting
• Start date: May 2015
• Est. completion date: May 2021

Study information

• Verified date: May 2018
• Source: Graftys SA
• Contact: Mehan ALTAIFI
• Phone: +33(0) 442 603 000
• Email: mehan.altaifi[@]graftys.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Cyst
• Bone Cysts
• Bone Disease
• Bone Diseases
• Fracture Bone
• Fractures, Bone

Locations

Country	Name	City	State
France	Hôpital La Timone	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Graftys SA	Clinfile

Countries where clinical trial is conducted

France,  Germany,  Italy,  Martinique,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Device Effect rate	Rate of Adverse Events related to bone substitutes (registry devices) for the follow-up period of patients.	For 24 months
Secondary	Technical Success rate	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)).	At surgical procedure
Secondary	Device Deficiencies rate	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.	At surgical procedure
Secondary	Serious Adverse Events rate in the peroperative period	Serious Adverse Event is defined as any adverse event that: Led to a death,; Led to serious deterioration in health of the subject that either resulted in: a life-threatening illness or injury, or; a permanent impairment of a body structure or a body function, or; in-patient or prolonged hospitalization, or; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.; Led to fetal distress, fetal death or a congenital abnormality or birth defect.	At surgical procedure
Secondary	Serious Adverse Events rate during the follow-up period	Serious Adverse Event is defined as any adverse event that: Led to a death,; Led to serious deterioration in health of the subject that either resulted in: a life-threatening illness or injury, or; a permanent impairment of a body structure or a body function, or; in-patient or prolonged hospitalization, or; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.; Led to fetal distress, fetal death or a congenital abnormality or birth defect.	3 months post index procedure
Secondary	Serious Adverse Events rate during the follow-up period	Serious Adverse Event is defined as any adverse event that: Led to a death,; Led to serious deterioration in health of the subject that either resulted in: a life-threatening illness or injury, or; a permanent impairment of a body structure or a body function, or; in-patient or prolonged hospitalization, or; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.; Led to fetal distress, fetal death or a congenital abnormality or birth defect.	6 months post index procedure
Secondary	Serious Adverse Events rate during the follow-up period	Serious Adverse Event is defined as any adverse event that: Led to a death,; Led to serious deterioration in health of the subject that either resulted in: a life-threatening illness or injury, or; a permanent impairment of a body structure or a body function, or; in-patient or prolonged hospitalization, or; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.; Led to fetal distress, fetal death or a congenital abnormality or birth defect.	9 months post index procedure
Secondary	Serious Adverse Events rate during the follow-up period	Serious Adverse Event is defined as any adverse event that: Led to a death,; Led to serious deterioration in health of the subject that either resulted in: a life-threatening illness or injury, or; a permanent impairment of a body structure or a body function, or; in-patient or prolonged hospitalization, or; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.; Led to fetal distress, fetal death or a congenital abnormality or birth defect.	12 months post index procedure
Secondary	Serious Adverse Events rate during the follow-up period	Serious Adverse Event is defined as any adverse event that: Led to a death,; Led to serious deterioration in health of the subject that either resulted in: a life-threatening illness or injury, or; a permanent impairment of a body structure or a body function, or; in-patient or prolonged hospitalization, or; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.; Led to fetal distress, fetal death or a congenital abnormality or birth defect.	24 months post index procedure
Secondary	Bone reconstruction evolution after surgery (if X-rays are available)	X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).	3 months post index procedure
Secondary	Bone reconstruction evolution after surgery (if X-rays are available)	X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).	6 months post index procedure
Secondary	Bone reconstruction evolution after surgery (if X-rays are available)	X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).	9 months post index procedure
Secondary	Bone reconstruction evolution after surgery (if X-rays are available)	X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).	12 months post index procedure
Secondary	Bone reconstruction evolution after surgery (if X-rays are available)	X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).	24 months post index procedure
Secondary	Quality of life score at baseline (EQ-5D-3L)	This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.	At baseline (pre-operative)
Secondary	Quality of life score evolution after surgery (EQ-5D-3L)	This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.	3 months post index procedure
Secondary	Quality of life score evolution after surgery (EQ-5D-3L)	This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.	6 months post index procedure
Secondary	Quality of life score evolution after surgery (EQ-5D-3L)	This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.	9 months post index procedure
Secondary	Quality of life score evolution after surgery (EQ-5D-3L)	This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.	12 months post index procedure
Secondary	Quality of life score evolution after surgery (EQ-5D-3L)	This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.	24 months post index procedure
Secondary	Functional score at baseline (if applicable according to the type of bone defect/medical indication).	Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect: Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).; Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form); Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form); Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.	At baseline (pre-operative)
Secondary	Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).	Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect: Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).; Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form); Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form); Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.	3 months post index procedure
Secondary	Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).	Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect: Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).; Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form); Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form); Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.	6 months post index procedure
Secondary	Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).	Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect: Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).; Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form); Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form); Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.	9 months post index procedure
Secondary	Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).	Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect: Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).; Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form); Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form); Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.	12 months post index procedure
Secondary	Functional score evolution after surgery (if applicable according to the type of bone defect/medical indication).	Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect: Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).; Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form); Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form); Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.	24 months post index procedure
Secondary	Surgeon's Satisfaction survey with registry device	Surgeon's Satisfaction survey with registry device (about mixing ability, injecting ability and moldability) thanks to a 100-mm Visual Analog Scale (VAS). A score of zero indicated absolutely inacceptable, while a score of 100 indicated very satisfying.	At surgical procedure