An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects
Recruiting now
Conditions studied: Limb Fracture, Bone Loss
In brief
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 different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group. Reports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations. In a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.
Key facts
- Study ID
- NCT04112992
- Run by
- AO Innovation Translation Center
- People needed
- 600
- Starts
- 2024-07-03
- Expected to finish
- 2029-03-30
- Last updated by the study team
- 2025-08-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedar Sinai — Los Angeles, California, United States (enrolling)
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)
- John Hunter Hospital — Newcastle, Australia (enrolling)
- Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia — Rio de Janeiro, Brazil (enrolling)
- Hospital Base Valdivia — Valdivia, Chile (enrolling)
- Universitätsspital Gießen — Giessen, Germany (enrolling)
- Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie) — Münster, Germany (enrolling)
- Paras HMRI Hospital Patna — Patna, India (enrolling)
- Academisch Ziekenhuis Maastricht (Dept. of Surgery) — Maastricht, Netherlands (enrolling)
- Radboud University Medical Center — Nijmegen, Netherlands (enrolling)
- Kyungpook National University Hospital (Orthopaedics) — Daegu, South Korea (enrolling)
- Universitätsspital Zürich (Klinik für Traumatologie) — Zurich, Switzerland (enrolling)
- Hospital Pablo Tobon Uribe — Medellín, Colombia (enrolling)
- University Hospital Frankfurt — Frankfurt, Germany (enrolling)
- Hospital Universitario de la Samaritana — Bogotá, Colombia
- Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery) — Leeds, United Kingdom
- Hospital Universitario de Caracas — Caracas, Venezuela
- Central Hospital of Border Guard Service of Ukraine — Kyiv, Ukraine
- Universitätsklinikum Heidelberg (Unfallchirurgie) — Heidelberg, Germany
- Tygerberg Hospital — Cape Town, South Africa
- Krankenhaus Johanneum — Wildeshausen, Germany
Full record on ClinicalTrials.gov
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