Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04112992




Registration number
NCT04112992
Ethics application status
Date submitted
30/09/2019
Date registered
2/10/2019
Date last updated
15/10/2024

Titles & IDs
Public title
An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects
Scientific title
An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects
Secondary ID [1] 0 0
LoBoDe Registry
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limb Fracture 0 0
Bone Loss 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Any treatment that is used for a defect of any long bone

Treatment: Surgery: Any treatment that is used for a defect of any long bone
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Baseline characteristics
Timepoint [1] 0 0
Pre-operative
Primary outcome [2] 0 0
Bone defect details
Timepoint [2] 0 0
Pre-operative and/or intraoperative
Primary outcome [3] 0 0
Trauma assessment
Timepoint [3] 0 0
Pre-operative and/or intraoperative
Primary outcome [4] 0 0
evaluate the bone defect in the context of previous interventions
Timepoint [4] 0 0
Intraoperative
Primary outcome [5] 0 0
Surgical details & Intraoperative findings 1
Timepoint [5] 0 0
Intraoperative
Primary outcome [6] 0 0
Surgical details & Intraoperative findings 2
Timepoint [6] 0 0
Intraoperative
Primary outcome [7] 0 0
Functional Outcome
Timepoint [7] 0 0
6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 12 months)
Primary outcome [8] 0 0
Patient related outcome / Quality of life 1
Timepoint [8] 0 0
Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
Primary outcome [9] 0 0
Patient related outcome / Quality of life 2
Timepoint [9] 0 0
Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
Primary outcome [10] 0 0
Radiological Outcome
Timepoint [10] 0 0
Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2029
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
2310 - Newcastle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Chile
State/province [4] 0 0
Valdivia
Country [5] 0 0
Colombia
State/province [5] 0 0
Bogotá
Country [6] 0 0
Colombia
State/province [6] 0 0
Medellín
Country [7] 0 0
Germany
State/province [7] 0 0
Frankfurt
Country [8] 0 0
Germany
State/province [8] 0 0
Gießen
Country [9] 0 0
Germany
State/province [9] 0 0
Heidelberg
Country [10] 0 0
Germany
State/province [10] 0 0
Münster
Country [11] 0 0
India
State/province [11] 0 0
Patna
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Daegu
Country [13] 0 0
Netherlands
State/province [13] 0 0
Maastricht
Country [14] 0 0
Netherlands
State/province [14] 0 0
Nijmegen
Country [15] 0 0
South Africa
State/province [15] 0 0
Cape Town
Country [16] 0 0
Switzerland
State/province [16] 0 0
Zürich
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Other
Name
AO Innovation Translation Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04112992
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hans-Christoph Pape, MD
Address 0 0
University Hospital Zurich Department of Trauma Surgery
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alix Frischknecht
Address 0 0
Country 0 0
Phone 0 0
+41 79 606 41 48
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04112992