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

Last updated: March 20, 2025
Sponsor: AO Innovation Translation Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Bone Density

Osteopenia

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

    Terminated

  • John Hunter Hospital

    Newcastle, 2310
    Australia

    Active - Recruiting

  • Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia

    Rio De Janeiro, 22430-160
    Brazil

    Site Not Available

  • Hospital Base Valdivia

    Valdivia, 5090146
    Chile

    Active - Recruiting

  • Hospital Universitario de la Samaritana

    Bogotá, 110411
    Colombia

    Suspended

  • Hospital Pablo Tobon Uribe

    Medellín,
    Colombia

    Active - Recruiting

  • University Hospital Frankfurt

    Frankfurt,
    Germany

    Active - Recruiting

  • Universitätsspital Gießen

    Gießen, 35385
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg (Unfallchirurgie)

    Heidelberg,
    Germany

    Terminated

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

    Münster,
    Germany

    Active - Recruiting

  • Paras HMRI Hospital Patna

    Patna, 800014
    India

    Active - Recruiting

  • Kyungpook National University Hospital (Orthopaedics)

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Academisch Ziekenhuis Maastricht (Dept. of Surgery)

    Maastricht,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen, 6525
    Netherlands

    Active - Recruiting

  • Tygerberg Hospital

    Cape Town, 7505
    South Africa

    Site Not Available

  • Universitätsspital Zürich (Klinik für Traumatologie)

    Zürich,
    Switzerland

    Active - Recruiting

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

    Leeds,
    United Kingdom

    Site Not Available

  • Cedar Sinai

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Cleveland Clinic

    Mayfield Heights, Ohio 44124
    United States

    Suspended

  • Ascension St. John Medical Center (Orthopaedics)

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

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