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

AO Innovation Translation Center

Status: Enrolling

Conditions: Limb Fracture; Bone Loss

Treatments: Procedure: Any treatment that is used for a defect of any long bone

Study type: Observational

Funder types: Other

Identifiers

NCT04112992

LoBoDe Registry

Details and patient eligibility

About

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.

Full description

The purpose of this project is to set up an international, multicenter registry of patient presenting with defects in long bones. Up to date, treatment remains challenging with little evidenced-based recommendations.

For this purpose, any patient who presents at a study center with a bone defect of the defined expansion of any long bone is eligible for inclusion. Over a 3-year period as many patients as possible are included from the participating sites, at least 600 patients should be included in the registry. Details on any surgical intervention that is used to treat a bone defect will be recorded. Further patient-related and other pre-defined outcome measures will be collected.

There is no formal hypothesis to this registry, hence it will help to identify prevalence and underlying etiologies, evaluate treatment strategies, and highlight possible challenges and complications - and will so help to gather clinical evidence to provide better treatment for patients suffering from a long bone defect.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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