International registry for long bone defects after trauma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to establish a multicenter international registry to collect data on patients with long bone defects, primarily post-traumatic. The registry will gather information on the prevalence, current treatment methods, complications, and outcomes associated with these defects. Over a three-year period, the study intends to enroll at least 600 patients from various participating sites, documenting details of surgical interventions and other relevant patient outcomes. The goal is to create a comprehensive database that can inform better treatment strategies for individuals suffering from long bone defects.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedar Sinai
  Los Angeles, California, United States Recruiting
• Sinai Hospital of Baltimore
  Baltimore, Maryland, United States Recruiting
• John Hunter Hospital
  Newcastle, Australia Recruiting
• Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
  Rio de Janeiro, Brazil Recruiting
• Hospital Base Valdivia
  Valdivia, Chile Recruiting
• Hospital Pablo Tobon Uribe
  Medellín, Colombia Recruiting

Study contacts

• Principal investigator: Hans-Christoph Pape, MD — University Hospital Zurich Department of Trauma Surgery
• Study coordinator: Marco Minoia
• Email: marco.minoia@aofoundation.org
• Phone: +41 79 612 09 67

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.