An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Procedure
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedar Sinai
RECRUITING
Los Angeles
Maryland
Sinai Hospital of Baltimore
RECRUITING
Baltimore
Other Locations
Australia
John Hunter Hospital
RECRUITING
Newcastle
Bolivarian Republic of Venezuela
Hospital Universitario de Caracas
NOT_YET_RECRUITING
Caracas
Brazil
Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
RECRUITING
Rio De Janeiro
Chile
Hospital Base Valdivia
RECRUITING
Valdivia
Colombia
Hospital Universitario de la Samaritana
SUSPENDED
Bogotá
Hospital Pablo Tobon Uribe
RECRUITING
Medellín
Germany
University Hospital Frankfurt
RECRUITING
Frankfurt
Universitätsspital Gießen
RECRUITING
Giessen
Universitätsklinikum Heidelberg (Unfallchirurgie)
TERMINATED
Heidelberg
Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)
RECRUITING
Münster
Krankenhaus Johanneum
NOT_YET_RECRUITING
Wildeshausen
India
Paras HMRI Hospital Patna
RECRUITING
Patna
Netherlands
Academisch Ziekenhuis Maastricht (Dept. of Surgery)
RECRUITING
Maastricht
Radboud University Medical Center
RECRUITING
Nijmegen
Republic of Korea
Kyungpook National University Hospital (Orthopaedics)
RECRUITING
Daegu
South Africa
Tygerberg Hospital
NOT_YET_RECRUITING
Cape Town
Switzerland
Universitätsspital Zürich (Klinik für Traumatologie)
RECRUITING
Zurich
Ukraine
Central Hospital of Border Guard Service of Ukraine
NOT_YET_RECRUITING
Kyiv
United Kingdom
Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)
NOT_YET_RECRUITING
Leeds
Contact Information
Primary
Marco Minoia
marco.minoia@aofoundation.org
+41 79 612 09 67
Backup
Joelle Kägi
joelle.kaegi@aofoundation.org
+41 79 549 32 83
Time Frame
Start Date: 2024-07-03
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 600
Related Therapeutic Areas
Sponsors
Leads: AO Innovation Translation Center

This content was sourced from clinicaltrials.gov

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