An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

Last updated: August 28, 2025
Sponsor: AO Innovation Translation Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Osteopenia

Bone Density

Treatment

Any treatment that is used for a defect of any long bone

Clinical Study ID

NCT04112992
LoBoDe Registry
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 accordingto the registry plan

  • Signed and dated EC/IRB approved written informed consent OR

  • Written consent provided according to the IRB/EC defined and approvedprocedures for patients who are not able to provide independent writteninformed consent

Exclusion

Exclusion Criteria:

  • Any oblique defect that has less than 8cm expansion when adding the defect size ofall four cortices

  • Any not medically managed severe systemic disease

  • Pregnancy

  • Prisoners

  • Participation in any other medical device or medicinal product registry within theprevious 3 months that could influence the results of the present registry

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Any treatment that is used for a defect of any long bone
Phase:
Study Start date:
July 03, 2024
Estimated Completion Date:
March 30, 2029

Study 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 recommendations.

For this purpose, any patient who presents at a study center with a bone defect of the defined expansion of any long bone is eligible for inclusion. Over a 3-year period as many patients as possible are included from the participating sites, at least 600 patients should be included in the registry. Details on any surgical intervention that is used to treat a bone defect will be recorded. Further patient-related and other pre-defined outcome measures will be collected.

There is no formal hypothesis to this registry, hence it will help to identify prevalence and underlying etiologies, evaluate treatment strategies, and highlight possible challenges and complications - and will so help to gather clinical evidence to provide better treatment for patients suffering from a long bone defect.

Connect with a study center

  • Hospital Italiano Buenos Aires

    Buenos Aires, 1199
    Argentina

    Site Not Available

  • John Hunter Hospital

    Newcastle, 2310
    Australia

    Site Not Available

  • John Hunter Hospital

    Newcastle 2155472, 2310
    Australia

    Active - Recruiting

  • Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia

    Rio De Janeiro, 22430-160
    Brazil

    Site Not Available

  • Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia

    Rio de Janeiro 3451190, 22430-160
    Brazil

    Active - Recruiting

  • Hospital Base Valdivia

    Valdivia, 5090146
    Chile

    Site Not Available

  • Hospital Base Valdivia

    Valdivia 3868707, 5090146
    Chile

    Active - Recruiting

  • Hospital Universitario de la Samaritana

    Bogotá, 110411
    Colombia

    Site Not Available

  • Hospital Universitario de la Samaritana

    Bogotá 3688689, 110411
    Colombia

    Suspended

  • Hospital Pablo Tobon Uribe

    Medellín,
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellín 3674962,
    Colombia

    Active - Recruiting

  • University Hospital Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • University Hospital Frankfurt

    Frankfurt 2925536,
    Germany

    Active - Recruiting

  • Universitätsspital Gießen

    Giessen 2920512, 35385
    Germany

    Active - Recruiting

  • Universitätsspital Gießen

    Gießen, 35385
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg (Unfallchirurgie)

    Heidelberg,
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg (Unfallchirurgie)

    Heidelberg 2907911,
    Germany

    Terminated

  • Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)

    Münster,
    Germany

    Site Not Available

  • Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)

    Münster 2867543,
    Germany

    Active - Recruiting

  • Krankenhaus Johanneum

    Wildeshausen 2808893, 27793
    Germany

    Site Not Available

  • Paras HMRI Hospital Patna

    Patna, 800014
    India

    Site Not Available

  • Paras HMRI Hospital Patna

    Patna 1260086, 800014
    India

    Active - Recruiting

  • Kyungpook National University Hospital (Orthopaedics)

    Daegu,
    Korea, Republic of

    Site Not Available

  • Academisch Ziekenhuis Maastricht (Dept. of Surgery)

    Maastricht,
    Netherlands

    Site Not Available

  • Academisch Ziekenhuis Maastricht (Dept. of Surgery)

    Maastricht 2751283,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen, 6525
    Netherlands

    Site Not Available

  • Radboud University Medical Center

    Nijmegen 2750053, 6525
    Netherlands

    Active - Recruiting

  • Tygerberg Hospital

    Cape Town, 7505
    South Africa

    Site Not Available

  • Tygerberg Hospital

    Cape Town 3369157, 7505
    South Africa

    Site Not Available

  • Kyungpook National University Hospital (Orthopaedics)

    Daegu 1835329,
    South Korea

    Active - Recruiting

  • Universitätsspital Zürich (Klinik für Traumatologie)

    Zurich 2657896,
    Switzerland

    Active - Recruiting

  • Universitätsspital Zürich (Klinik für Traumatologie)

    Zürich,
    Switzerland

    Site Not Available

  • Central Hospital of Border Guard Service of Ukraine

    Kyiv 703448,
    Ukraine

    Site Not Available

  • Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)

    Leeds,
    United Kingdom

    Site Not Available

  • Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)

    Leeds 2644688,
    United Kingdom

    Site Not Available

  • Cedar Sinai

    Los Angeles, California 90048
    United States

    Site Not Available

  • Cedar Sinai

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore 4347778, Maryland 4361885 21215
    United States

    Active - Recruiting

  • Cleveland Clinic

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Ascension St. John Medical Center (Orthopaedics)

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Hospital Universitario de Caracas

    Caracas 3646738,
    Venezuela

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.