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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AO Innovation Translation Center
Study ID
NCT04112992
Status
Recruiting
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Conditions

  • Bone Loss
  • Limb Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Any treatment that is used for a defect of any long bone — PROCEDURE
    Any treatment that is used for a defect of any long bone. All treatments are based on individual clinician's judgement and the patient characteristics. The registry does not dictate any specific treatment.

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Aug 2025
Primary completion
May 31, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
600 participants (estimated)

Primary Outcome Measure

Baseline characteristics [ Time Frame: Pre-operative ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cedar SinaiLos AngelesCalifornia90048
Geoffrey Marecek, MD
[email protected]
Sinai Hospital of BaltimoreBaltimoreMaryland21215
Janet Conway

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By research site
Cedar Sinai· Los Angeles, CASinai Hospital of Baltimore· Baltimore, MD

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