An international, multicenter, prospective registry to investigatetreatment options and their outcomes on post-traumatic long bonesdefects - NI

AO Innovation Translation Center (AO ITC)0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1. Age = 18 years
•2. Skeletally mature
•3. Posttraumatic aseptic long bone defect > 2 cm in each cortex in humerus, femur or tibia, either
•3a. initially after injury or
•3b. after surgical debridement
•4. Informed consent obtained, i.e.:
•4a. Ability to understand the content of the patient information/ICF
•4b. Willingness and ability to participate in the clinical investigation according to the registry plan
•4c. Signed and dated EC/IRB approved written informed consent
•Written consent is provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent

•1. Any oblique defect that has less than 8 cm expansion when adding the defect size of all four cortices
•2. Any not medically managed severe systemic disease
•3. Pregnancy
•4. Prisoners
•5. Participation in any other medical device or medicinal product registry within the previous 3 months that could influence the results of the present registry

发起方

AO Innovation Translation Center (AO ITC)