UnknownNot Applicable

Calcium Phosphate Cement Registry (CPC Registry)

France, Germany500 participantsStarted 2015-05

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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

What they're measuring

Adverse Device Effect rate

Timeframe: For 24 months

Trial details

NCT IDNCT02575352

SponsorGraftys SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-05

Contact for this trial

Mehan ALTAIFI

+33(0) 442 603 000 mehan.altaifi@graftys.fr

View on ClinicalTrials.gov More Bone Disease trials