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

Bone Loss Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bone Loss
• Limb Fracture

• NCT number: NCT04112992
• Study type: Observational [Patient Registry]
• Source: AO Innovation Translation Center
• Contact: Alix Frischknecht
• Phone: +41 79 606 41 48
• Email: alix.frischknecht@aofoundation.org
• Status: Not yet recruiting
• Start date: April 30, 2024
• Completion date: March 30, 2029