CTRI/2024/05/066962
Not yet recruiting
未知
An international, multicenter, prospective registry to investigatetreatment options and their outcomes on post-traumatic long bonesdefects - NI
AO Innovation Translation Center (AO ITC)0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AO Innovation Translation Center (AO ITC)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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