International registry for long bone defects after trauma
An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects
This study is creating a global database to collect information on patients with long bone injuries from trauma to help improve treatment options and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AO Innovation Translation Center Academic / other |
| Locations | 21 sites (Los Angeles, California and 20 other locations) |
| Trial ID | NCT04112992 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with post-traumatic long bone defects greater than 2 cm.
Not a fit: Patients with severe systemic diseases or those with specific types of bone defects that do not meet the inclusion criteria may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved treatment recommendations and outcomes for patients with long bone defects.
How similar studies have performed: While there is limited evidence on treatment recommendations for long bone defects, this registry approach is novel and aims to fill a significant gap in clinical knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California and 20 other locations
- 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 Universitario de la Samaritana — Bogotá, Colombia (Suspended)
- Hospital Pablo Tobon Uribe — Medellín, Colombia (Recruiting)
- University Hospital Frankfurt — Frankfurt, Germany (Recruiting)
- Universitätsspital Gießen — Giessen, Germany (Recruiting)
- Universitätsklinikum Heidelberg (Unfallchirurgie) — Heidelberg, Germany (Terminated)
- Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie) — Münster, Germany (Recruiting)
- Krankenhaus Johanneum — Wildeshausen, Germany (Not_yet_recruiting)
- Paras HMRI Hospital Patna — Patna, India (Recruiting)
- Academisch Ziekenhuis Maastricht (Dept. of Surgery) — Maastricht, Netherlands (Recruiting)
- Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
- Tygerberg Hospital — Cape Town, South Africa (Not_yet_recruiting)
- Kyungpook National University Hospital (Orthopaedics) — Daegu, South Korea (Recruiting)
- Universitätsspital Zürich (Klinik für Traumatologie) — Zurich, Switzerland (Recruiting)
- Central Hospital of Border Guard Service of Ukraine — Kyiv, Ukraine (Not_yet_recruiting)
- Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery) — Leeds, United Kingdom (Not_yet_recruiting)
- Hospital Universitario de Caracas — Caracas, Venezuela (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.