RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-03
Study Completion:2029-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04112992

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Skeletally mature
  3. * Post traumatic bone defect \> 2 cm either
  4. * initially after injury or
  5. * after surgical debridement
  6. * Informed consent obtained, i.e.:
  7. * Ability to understand the content of the patient information/ICF
  8. * Willingness and ability to participate in the clinical investigation according to the registry plan
  9. * Signed and dated EC/IRB approved written informed consent OR
  10. * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent
  1. * Any oblique defect that has less than 8cm expansion when adding the defect size of all four cortices
  2. * Any not medically managed severe systemic disease
  3. * Pregnancy
  4. * Prisoners
  5. * Participation in any other medical device or medicinal product registry within the previous 3 months that could influence the results of the present registry

Contacts and Locations

Study Contact

Alix Frischknecht
CONTACT
+41 79 606 41 48
alix.frischknecht@aofoundation.org
Joelle Kägi
CONTACT
joelle.kaegi@aofoundation.org

Principal Investigator

Hans-Christoph Pape, MD
PRINCIPAL_INVESTIGATOR
University Hospital Zurich Department of Trauma Surgery

Study Locations (Sites)

Cedar Sinai
Los Angeles, California, 90048
United States
Cleveland Clinic
Mayfield Heights, Ohio, 44124
United States

Collaborators and Investigators

Sponsor: AO Innovation Translation Center

  • Hans-Christoph Pape, MD, PRINCIPAL_INVESTIGATOR, University Hospital Zurich Department of Trauma Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-03
Study Completion Date2029-03-30

Study Record Updates

Study Start Date2024-07-03
Study Completion Date2029-03-30

Terms related to this study

Keywords Provided by Researchers

  • long bone defect

Additional Relevant MeSH Terms

  • Limb Fracture
  • Bone Loss