Clinical trial · Observational
Calcium Phosphate Cement Registry (CPC Registry)
Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Cyst | — | UNRESOLVED | — |
| Bone Disease | — | UNRESOLVED | — |
| Fracture Bone | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Adverse Device Effect rate
- timeFrame
- For 24 months
- description
- Rate of Adverse Events related to bone substitutes (registry devices) for the follow-up period of patients.
Secondary outcomes (26)
- measure
- Technical Success rate
- timeFrame
- At surgical procedure
- description
- 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)).
- measure
- Device Deficiencies rate
- timeFrame
- At surgical procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available