Home › Metabolic Bone Diseases › NCT04112992

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

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

Who can join

Ages 18 and older · All sexes

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 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

Exclusion Criteria:

* 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

About the study

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 is being tested

• Any treatment that is used for a defect of any long bone (procedure)

Sponsor: AO Innovation Translation Center · Participants: 600 · Started: Jul 3, 2024

Contact the study team

• Marco Minoia · Phone: +41 79 612 09 67
• Joelle Kägi · Phone: +41 79 549 32 83

Official record on ClinicalTrials.gov — NCT04112992

Locations in the U.S.

Conditions

• Metabolic Bone Diseases

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.