An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects
AO Innovation Translation Center
Summary
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.
Description
The purpose of this project is to set up an international, multicenter registry of patient presenting with defects in long bones. Up to date, treatment remains challenging with little evidenced-based recommendations. For this purpose, any patient who presents at a study center with a bone defect of the defined expansion of any long bone is eligible for inclusion. Over a 3-year period as many patients as possible are included from the participating sites, at least 600 patients should be included in the registry. Details on any surgical intervention that is used to treat a bone defect will be r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureAny treatment that is used for a defect of any long bone
Any treatment that is used for a defect of any long bone. All treatments are based on individual clinician's judgement and the patient characteristics. The registry does not dictate any specific treatment.
Locations (21)
- Cedar SinaiLos Angeles, California
- Sinai Hospital of BaltimoreBaltimore, Maryland
- John Hunter HospitalNewcastle
- Hospital Municipal Miguel Couto Serviço de Ortopedia e TraumatologiaRio de Janeiro
- Hospital Base ValdiviaValdivia
- Hospital Universitario de la SamaritanaBogotá