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An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

Recruitingn/aAges 18 Years - anyAllAO Innovation Translation Center
NCT04112992 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Long bone defect (LBD) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. Long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group. Reports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations. In a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Skeletally mature * Post traumatic bone defect \> 2 cm either * initially after injury or * after surgical debridement * Informed consent obtained, i.e.: * Ability to understand the content of the patient information/ICF * Willingness and ability to participate in the clinical investigation according to the registry plan * Signed and dated EC/IRB approved written informed consent OR * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent Exclusion Criteria: * Any oblique defect that has less than 8cm expansion when adding the defect size of all four cortices * Any not medically managed severe systemic disease * Pregnancy * Prisoners * Participation in any other medical device or medicinal product registry within the previous 3 months that could influence the results of the present registry
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What it tests

  • Any treatment that is used for a defect of any long bone
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Where

21 sites
Cedar Sinai
Los Angeles, United States
Sinai Hospital of Baltimore
Baltimore, United States
John Hunter Hospital
Newcastle, Australia
Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
Rio de Janeiro, Brazil
Hospital Base Valdivia
Valdivia, Chile
Hospital Universitario de la Samaritana
Bogotá, Colombia
Hospital Pablo Tobon Uribe
Medellín, Colombia
University Hospital Frankfurt
Frankfurt, Germany

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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