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Clinical Trials/CTRI/2024/05/066962
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational

Investigators

Sponsor
AO Innovation Translation Center (AO ITC)

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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