Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT02056834
Eligibility Criteria:
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, including AIDS and HIV
* Active Hepatitis (receiving medical treatment within two years)
* Active systemic or local infection
* Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing
* Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol)
* Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \>1 month within last 12 months
* Pregnant or planning to become pregnant during study period
* Involved in study of another investigational product that may affect outcome
* History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales
* Patients who are incarcerated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02056834
Study Brief:
Protocol Section:
NCT02056834