The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects with closed proximal tibial fractures defined by : Tibia plateau, Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
* Skeletally mature adult 18 years or older, with close of growth plate at the time of surgery
* Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
* Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study
Exclusion Criteria:
* Open fractures with severe soft tissue damage
* Proximal tibial fractures with tumor or osteomyelitis
* Any tibial anatomy or disease process that would interfere with deployment or performance of the device as defined by the surgeon
* Osteopenia or Osteoporosis: if dual energy x-ray absorptiometry (DEXA) is required, exclusion will be defined as a DEXA bone density measured T score \<=-1.0
* Known history of Paget's disease, osteomalacia, or any other metabolic bone disease
* Morbid obesity defined as a body mass index \>40 kg/m2 or weight more than 50 kg over ideal body weight
* Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy \>5 years
* Known or documented history of communicable disease, incl…