LoBoDe
Research type
Research Study
Full title
An international, multicenter, prospective registry to investigate treatment options and their outcomes on post-traumatic long bones defects
IRAS ID
305437
Contact name
Ramona Ritzmann
Contact email
Sponsor organisation
AO Foundation, AO Innovation Translation Center (AO ITC)
Duration of Study in the UK
5 years, 11 months, 29 days
Research summary
A bone defect is a lack or loss of bone tissue where it normally should occur. Mostly relevant are defects in long bones, such as the femur, tibia and humerus, hence "long bone defect" (LBD). There exist many different conditions or diseases, respectively, that lead to a LBD. Till today, the treatment of a long bone defect remains challenging with little evidence and no clear treatment recommendations.
The aim of this prospective, international, multicenter registry is to gain an overview on different treatment options for this important clinical challenge, identify possible factors that influence the outcome and moreover evaluate the outcome from the patient's perspective. To learn more about the patient's perspective and his quality of life, we will ask the patients to fill in different patient reported outcome questionnaires.
Mature patients with a LBD in the humerus, femur or tibia will be eligible to participate in this registry. The registry does not dictate any specific treatment. All patients will be treated according to local standard of care. In the scope of this registry, the patient will be followed up until 6 months after bone healing was complete. Within this time period, the treating physician will assess the patients' characteristics, medical history as well as previous interventions and bone defect details. Images, that were made per standard of care, will be radiologically evaluated in the scope of this registry.
This multi-national registry offers a unique opportunity to document treatment data on LBD prospectively and to build a high-quality database. This data can later on be used to provide evidence-based treatment recommendations to the physicians all over the world.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
24/YH/0163
Date of REC Opinion
16 Oct 2024
REC opinion
Further Information Favourable Opinion