Actively Recruiting
International Multicenter Registry to Study Treatments and Outcomes for Post-traumatic Long Bone Defects
Led by AO Innovation Translation Center · Updated on 2025-08-29
600
Participants Needed
21
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Long bone defects (LBD) are focal losses of bone tissue in the long bones of the arms or legs, often caused by trauma, tumors, or infections. Post-traumatic defects make up the largest group and present complex treatment challenges. This international, multicenter registry aims to collect detailed information on the prevalence, treatment methods, complications, and outcomes of post-traumatic long bone defects to improve clinical knowledge and care. Patients with long bone defects will be included from multiple centers over a 3-year period, aiming to enroll at least 600 participants. The registry will record any surgical treatments used, without dictating specific therapies, allowing individualized clinical decisions. Data collection will cover preoperative, intraoperative, and follow-up details, including the bone defect characteristics and surgical findings. Participants will undergo assessments before and during surgery, with follow-up evaluations at 6 and 12 months, or 6 months after bone healing, up to 18 months. These include functional outcomes, patient quality of life, and radiological imaging. The study will monitor patient progress and outcomes to better understand treatment effects and challenges for those with post-traumatic long bone defects.
CONDITIONS
Brief Title
An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Skeletally mature (fully grown bones)
- Post-traumatic bone defect greater than 2 cm either initially after injury or after surgical debridement
- Ability to understand patient information and provide informed consent
- Willingness and ability to participate according to the registry plan
- Signed and dated informed consent form or approved alternative consent procedure
You will not qualify if you...
- Any oblique bone defect with less than 8 cm expansion when adding defect sizes of all four cortices
- Severe systemic disease not medically managed
- Pregnancy
- Prisoner status
- Participation in another medical device or medicinal product registry within 3 months that could affect this registry's results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - Up to 1 week
Participants undergo assessments to document baseline characteristics, bone defect details, trauma assessments, and previous interventions before any treatment.
1 visit (in-person) for baseline and pre-operative assessments
Duration - Day of surgery plus immediate post-operative period
Participants receive any surgical treatment for the bone defect as judged by their clinician. Details of the surgery and intraoperative findings are recorded.
1 surgical visit plus intraoperative data collection
Duration - Up to 18 months
Participants are followed for functional outcomes, quality of life, and radiological assessments for up to 18 months after surgery or bone union to evaluate treatment success and complications.
Multiple follow-up visits including assessments at 6 months, 12 months, and possibly 18 months
Trial Site Locations
Total: 21 locations
1
Cedar Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
2
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
3
John Hunter Hospital
Newcastle, Australia, 2310
Actively Recruiting
4
Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
Rio de Janeiro, Brazil, 22430-160
Actively Recruiting
5
Hospital Base Valdivia
Valdivia, Chile, 5090146
Actively Recruiting
6
Hospital Universitario de la Samaritana
Bogotá, Colombia, 110411
Suspended
7
Hospital Pablo Tobon Uribe
Medellín, Colombia
Actively Recruiting
8
University Hospital Frankfurt
Frankfurt, Germany
Actively Recruiting
9
Universitätsspital Gießen
Giessen, Germany, 35385
Actively Recruiting
10
Universitätsklinikum Heidelberg (Unfallchirurgie)
Heidelberg, Germany
Terminated
11
Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)
Münster, Germany
Actively Recruiting
12
Krankenhaus Johanneum
Wildeshausen, Germany, 27793
Not Yet Recruiting
13
Paras HMRI Hospital Patna
Patna, India, 800014
Actively Recruiting
14
Academisch Ziekenhuis Maastricht (Dept. of Surgery)
Maastricht, Netherlands
Actively Recruiting
15
Radboud University Medical Center
Nijmegen, Netherlands, 6525
Actively Recruiting
16
Tygerberg Hospital
Cape Town, South Africa, 7505
Not Yet Recruiting
17
Kyungpook National University Hospital (Orthopaedics)
Daegu, South Korea
Actively Recruiting
18
Universitätsspital Zürich (Klinik für Traumatologie)
Zurich, Switzerland
Actively Recruiting
19
Central Hospital of Border Guard Service of Ukraine
Kyiv, Ukraine
Not Yet Recruiting
20
Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)
Leeds, United Kingdom
Not Yet Recruiting
21
Hospital Universitario de Caracas
Caracas, Venezuela
Not Yet Recruiting
Research Team
M
Marco Minoia
J
Joelle Kägi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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