Actively Recruiting

Age: 18Years +
All Genders
NCT04112992

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

Led by AO Innovation Translation Center · Updated on 2025-08-29

600

Participants Needed

21

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Skeletally mature
  • Post-traumatic bone defect greater than 2 cm either initially after injury or after surgical debridement
  • Ability to understand patient information and informed consent form
  • Willingness and ability to participate in the clinical investigation
  • Signed and dated written informed consent approved by ethics committee or institutional review board
  • Written consent per IRB/EC procedures if unable to provide independent written consent
Not Eligible

You will not qualify if you...

  • Oblique bone defect with less than 8 cm expansion when adding defect sizes of all four cortices
  • Any severe systemic disease not medically managed
  • Pregnancy
  • Prisoners
  • Participation in any other medical device or medicinal product registry within the previous 3 months that could affect results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 21 locations

1

Cedar Sinai

Los Angeles, California, United States, 90048

Actively Recruiting

2

Sinai Hospital of Baltimore

Baltimore, Maryland, United States, 21215

Actively Recruiting

3

John Hunter Hospital

Newcastle, Australia, 2310

Actively Recruiting

4

Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia

Rio de Janeiro, Brazil, 22430-160

Actively Recruiting

5

Hospital Base Valdivia

Valdivia, Chile, 5090146

Actively Recruiting

6

Hospital Universitario de la Samaritana

Bogotá, Colombia, 110411

Suspended

7

Hospital Pablo Tobon Uribe

Medellín, Colombia

Actively Recruiting

8

University Hospital Frankfurt

Frankfurt, Germany

Actively Recruiting

9

Universitätsspital Gießen

Giessen, Germany, 35385

Actively Recruiting

10

Universitätsklinikum Heidelberg (Unfallchirurgie)

Heidelberg, Germany

Terminated

11

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

Münster, Germany

Actively Recruiting

12

Krankenhaus Johanneum

Wildeshausen, Germany, 27793

Not Yet Recruiting

13

Paras HMRI Hospital Patna

Patna, India, 800014

Actively Recruiting

14

Academisch Ziekenhuis Maastricht (Dept. of Surgery)

Maastricht, Netherlands

Actively Recruiting

15

Radboud University Medical Center

Nijmegen, Netherlands, 6525

Actively Recruiting

16

Tygerberg Hospital

Cape Town, South Africa, 7505

Not Yet Recruiting

17

Kyungpook National University Hospital (Orthopaedics)

Daegu, South Korea

Actively Recruiting

18

Universitätsspital Zürich (Klinik für Traumatologie)

Zurich, Switzerland

Actively Recruiting

19

Central Hospital of Border Guard Service of Ukraine

Kyiv, Ukraine

Not Yet Recruiting

20

Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)

Leeds, United Kingdom

Not Yet Recruiting

21

Hospital Universitario de Caracas

Caracas, Venezuela

Not Yet Recruiting

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Research Team

M

Marco Minoia

CONTACT

J

Joelle Kägi

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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