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

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.

Conditions

Limb Fracture, Bone Loss

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Limb Fracture
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedar Sinai, Los Angeles, California, United States, 90048

Mayfield Heights

Cleveland Clinic, Mayfield Heights, Ohio, United States, 44124

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AO Innovation Translation Center,

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

Study Record Dates

2029-03-30