What this study is
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.
What's being tested
- Any treatment that is used for a defect of any long bone
Intervention · PROCEDURE
Any treatment that is used for a defect of any long bone. All treatments are based on individual clinician's judgement and the patient characteristics. The registry does not dictate any specific treatment.
Study details
- Official title
- An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects
- Sponsor
- AO Innovation Translation Center
- Conditions
- Limb Fracture · Bone Loss
- Enrolling
- 600 people
- Starts
- 2024-07-03
- Est. completion
- 2029-03-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (21)
19 openCedar Sinai
Los Angeles, California, United States
- Geoffrey Marecek, MD · ContactGeoffrey.Marecek@cshs.org
RecruitingSinai Hospital of Baltimore
Baltimore, Maryland, United States
- Janet Conway · Contact
Recruiting
19 sites outside the US
John Hunter Hospital
Newcastle, Australia
- Zsolt Balogh, Prof Dr Dr · Contactzsolt.balogh@hnehealth.nsw.gov.au
RecruitingHospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
Rio de Janeiro, Brazil
- Vincenzo Giordano, MD · Contactv_giordano@me.com
Recruiting- Recruiting
Hospital Pablo Tobon Uribe
Medellín, Colombia
- Carlos Oliver Valderrama-Molina, MD · Contactcvalderrama@hptu.org.co
RecruitingUniversity Hospital Frankfurt
Frankfurt, Germany
- Ingo Marzi, MD · Contactmarzi@trauma.uni-frankfurt.de
RecruitingUniversitätsspital Gießen
Giessen, Germany
- Christian Heiss, Prof Dr Dr · Contactchristian.heiss@chiru.med.uni-giessen.de
RecruitingUniversitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)
Münster, Germany
- Steffen Rosslenbroich, MD · ContactSteffen.Rosslenbroich@ukmuenster.de
RecruitingKrankenhaus Johanneum
Wildeshausen, Germany
- Ahmed Yaseen · Contact+4917671973159Yaseen.Ahmed@krankenhaus-johanneum.de
- Ahmed Yaseen · Principal investigator
Not yet recruiting- Recruiting
Academisch Ziekenhuis Maastricht (Dept. of Surgery)
Maastricht, Netherlands
- Martijn Poeze, MD · Contact+31433871956m.poeze@mumc.nl
RecruitingRadboud University Medical Center
Nijmegen, Netherlands
- Michael Edwards, MD · Contactmichael.edwards@radboudumc.nl
Recruiting- Not yet recruiting
Kyungpook National University Hospital (Orthopaedics)
Daegu, South Korea
- Chang-Wug Oh, MD · Contactcwoh@knu.ac.kr
RecruitingUniversitätsspital Zürich (Klinik für Traumatologie)
Zurich, Switzerland
- Hans-Christoph Pape, MD · Contact+ 41 (0)44 255 27 55Hans-Christoph.Pape@usz.ch
RecruitingCentral Hospital of Border Guard Service of Ukraine
Kyiv, Ukraine
- Dmytro Smolianets · Contactsmolianets.dmytro@gmail.com
- Dmytro Smolianets · Principal investigator
Not yet recruitingLeeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)
Leeds, United Kingdom
- Peter Giannoudis, MD · Contactpeter.giannoudis@nhs.net
Not yet recruitingHospital Universitario de Caracas
Caracas, Venezuela
- Manuel Malaret · Contact+584143119338manuel.malaret.b@gmail.com
- Manuel Malaret · Principal investigator
- Igor Escalante · Sub-investigator
Not yet recruitingHospital Universitario de la Samaritana
Bogotá, Colombia
SuspendedUniversitätsklinikum Heidelberg (Unfallchirurgie)
Heidelberg, Germany
Terminated
Study team
Sponsor
AO Innovation Translation Center
Study ID LoBoDe Registry
Principal investigator
Hans-Christoph Pape, MD
University Hospital Zurich Department of Trauma Surgery
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.