Status:
RECRUITING
An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects
Lead Sponsor:
AO Innovation Translation Center
Conditions:
Limb Fracture
Bone Loss
Eligibility:
All Genders
18+ years
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04112992
Start Date
July 3 2024
End Date
March 30 2029
Last Update
August 29 2025
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedar Sinai
Los Angeles, California, United States, 90048
2
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
3
John Hunter Hospital
Newcastle, Australia, 2310
4
Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
Rio de Janeiro, Brazil, 22430-160