Health Condition 1: T07- Unspecified multiple injuries
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
AO Innovation Translation Center (AO ITC)
AO Innovation Translation Center AO ITC
Eligibility
Inclusion criteria
Inclusion criteria: 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 OR 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome of management of post -traumatic long bones defects, To evaluate outcome and the quality of life after the treatment.Timepoint: 3 years enrollment period | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe patients characteristics and type of bone defect present, To evaluate the nature of the bone defect, induced by various causes, To describe surgical details and treatment modalities how the bone defect is treatedTimepoint: 36 months | — |
Countries
Belgium, Germany, India, Switzerland, United Kingdom, United States of America
Contacts
Public ContactRohit Kumar
Paras HMRI Hospital Patna
Outcome results
None listed