An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Innovation Translation Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Skeletally mature
Post traumatic bone defect > 2 cm either
initially after injury or
Disqualifiers
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
Trial population
Patients with a traumatic bone defect in any long bone
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Any treatment that is used for a defect of any long bone
Procedure/SurgeryAny 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Baseline characteristics
Demographics, medical history, comorbidity
Time frame
Pre-operative2
Bone defect details
* Affected bone * Localization: Proximal 1/3rd, middle 3rd, distal 1/3rd(for any bone) * Size (categorization according Karger classification; definition: a bone defect should be at least 2 cm (Karger Type II)) Type II: 2-5 cm Type III: 5-10 cm Type IV: \> 10 cm
Time frame
Pre-operative and/or intraoperative3
Trauma assessment
* Injury Severity Score (ISS): Grading for each item (points): No injury (0), Minor (1), Moderate (4), Serious (9), Severe (16), Critical (25), Unsurvivable (75) * Assessment: * Head and neck worst injury * Face worst injury * Chest worst injury * Abdomen worst injury * Extremity (including pelvis) worst injury * External worst injury * Gustilo \& Anderson classification for open fractures * Type I * Type II * Type IIIA * Type IIIB * Type IIIC * Tscherne classification for closed fracture and soft-tissue injuries * Grade 0 * Grade 1 * Grade 2 * Grade 3
Time frame
Pre-operative and/or intraoperative4
evaluate the bone defect in the context of previous interventions
Number of previous interventions: \<2, \<4, \>4
Time frame
IntraoperativeSponsors and contacts
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Source ClinicalTrials.gov