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

Launched by AO INNOVATION TRANSLATION CENTER · Sep 30, 2019

Keywords

ClinConnect Summary

This clinical trial is focused on understanding and improving treatments for long bone defects, which are areas where bone tissue is missing in the arms or legs due to injuries, infections, or tumors. These defects are a common issue after trauma, and they can make recovery challenging. The researchers aim to create an international registry that will collect information about how often these defects occur, the treatments currently being used, any problems that arise during treatment, and the outcomes for patients.

To participate in this study, individuals must be at least 18 years old and have a bone defect larger than 2 cm that is either present right after an injury or has developed after surgery to remove damaged tissue. Participants should be able to understand the study details and provide consent to join. The trial is currently recruiting participants and is open to anyone who meets these criteria. By joining this study, participants will help researchers gather important information that could lead to better treatment options for people with similar bone issues in the future.

Gender

ALL

Eligibility criteria

• 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