Limb FractureNCT04112992
An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects
An observational study of Limb Fracture and Bone Loss, run by AO Innovation Translation Center at 21 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limb Fracture, Bone Loss
- What is being tested?
- Any treatment that is used for a defect of any long bone
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 21 sitesin 14 countries
- Study dates
- 3 Jul 2024to 30 Mar 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a traumatic bone defect in any long bone
Who may be able to join
- Age ≥ 18 years
- Skeletally mature
- Post traumatic bone defect > 2 cm either
- initially after injury or
- after surgical debridement
- Informed consent obtained, i.e.:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 14 countries
Germany5 sites, 4 recruiting
- Recruiting
University Hospital Frankfurt
Frankfurt
Ingo Marzi, MD, marzi@trauma.uni-frankfurt.de
- Recruiting
Universitätsspital Gießen
Giessen, 35385
Christian Heiss, Prof Dr Dr, christian.heiss@chiru.med.uni-giessen.de
- Terminated
Universitätsklinikum Heidelberg (Unfallchirurgie)
Heidelberg
- Recruiting
Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)
Münster
Steffen Rosslenbroich, MD, Steffen.Rosslenbroich@ukmuenster.de
- Not yet recruiting
Krankenhaus Johanneum
Wildeshausen, 27793
Ahmed Yaseen, +4917671973159, Yaseen.Ahmed@krankenhaus-johanneum.de
Ahmed Yaseen
United States2 sites, 2 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Janet Conway
- Recruiting
Cedar Sinai
Los Angeles, California, 90048
Geoffrey Marecek, MD, Geoffrey.Marecek@cshs.org
Colombia2 sites, 1 recruiting
- Suspended
Hospital Universitario de la Samaritana
Bogotá, 110411
- Recruiting
Hospital Pablo Tobon Uribe
Medellín
Carlos Oliver Valderrama-Molina, MD, cvalderrama@hptu.org.co
Netherlands2 sites, 2 recruiting
- Recruiting
Academisch Ziekenhuis Maastricht (Dept. of Surgery)
Maastricht
Martijn Poeze, MD, +31433871956, m.poeze@mumc.nl
- Recruiting
Radboud University Medical Center
Nijmegen, 6525
Michael Edwards, MD, michael.edwards@radboudumc.nl
Australia1 site, 1 recruiting
- Recruiting
John Hunter Hospital
Newcastle, 2310
Zsolt Balogh, Prof Dr Dr, zsolt.balogh@hnehealth.nsw.gov.au
Brazil1 site, 1 recruiting
- Recruiting
Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
Rio de Janeiro, 22430-160
Vincenzo Giordano, MD, v_giordano@me.com
Chile1 site, 1 recruiting
- Recruiting
Hospital Base Valdivia
Valdivia, 5090146
Matías Sepulveda, Dr, contacto@matiassepulveda.com
India1 site, 1 recruiting
- Recruiting
Paras HMRI Hospital Patna
Patna, 800014
John Mukhopadhaya, MD, mukhoj@gmail.com
South Africa1 site, 1 recruiting
- Not yet recruiting
Tygerberg Hospital
Cape Town, 7505
Nando Ferreira, NFERREIRA@sun.ac.za
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Hospital (Orthopaedics)
Daegu
Chang-Wug Oh, MD, cwoh@knu.ac.kr
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich (Klinik für Traumatologie)
Zurich
Hans-Christoph Pape, MD, + 41 (0)44 255 27 55, Hans-Christoph.Pape@usz.ch
Ukraine1 site, 1 recruiting
- Not yet recruiting
Central Hospital of Border Guard Service of Ukraine
Kyiv
Dmytro Smolianets, smolianets.dmytro@gmail.com
Dmytro Smolianets
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)
Leeds
Peter Giannoudis, MD, peter.giannoudis@nhs.net
Venezuela1 site, 1 recruiting
- Not yet recruiting
Hospital Universitario de Caracas
Caracas
Manuel Malaret, +584143119338, manuel.malaret.b@gmail.com
Manuel Malaret
About this study
Official title: An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects
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.
Read the detailed 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.
- Conditions
- Limb Fracture, Bone Loss
- Being tested
- Any treatment that is used for a defect of any long bone
- Keywords
- long bone defect
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any treatment that is used for a defect of any long boneProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristics
Demographics, medical history, comorbidity
Measured: Pre-operative
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
Measured: Pre-operative and/or intraoperative
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
Measured: Pre-operative and/or intraoperative
evaluate the bone defect in the context of previous interventions
Number of previous interventions: <2, <4, >4
Measured: Intraoperative
Surgical details & Intraoperative findings 1
- Procedure type:
- One stage
- Staged (e.g. Masquelet technique / distraction osteogenesis / bone transport)
- Ilizarov
- Bone quality (good, fair, poor) by surgeon's discretion
- Soft tissue and vascularity (good, fair, poor) by surgeon's discretion
- Contamination (yes/no)
Specification:
- Metal from a bullet
- Metal from a pole
- Other Metal
- Wood
- Soil
- Others
- Surgical time (min)
- Stabilization technique: Internal device (extra- or intramedullary) / External device (For both, drop down menu will be used)
Measured: Intraoperative
Surgical details & Intraoperative findings 2
- Bone grafting
- Autografts
- Allograft(s)
- Other synthetics
- If applicable - time to harvest graft (in minutes)
- Graft enhancement yes / no
- Demineralized bone matrix (DBM)
- Bone morphogenetic protein (BMP)
- Stem cells
- Platelet rich plasma (PRP)
- Other
- Soft-tissue / vascular / microsurgical procedure yes / no
- Skin graft
- Local flap
- Free flap
- Additional treatment
- Systemic antibiotic treatment yes / no
- Local antibiotic treatment yes / no
- Post-operative use of a negative pressure dressings (NPWT) or vacuum-assisted closure (VAC) system yes / no
Measured: Intraoperative
Functional Outcome
- Assessment of limb function and loss of length
- Definition: anatomic shortening of the limb in comparison to the contralateral side
- Assessment in cm
- Any orthotic used to equalize leg length
Measured: 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 12 months)
Patient related outcome / Quality of life 1
Patient-Reported Outcomes Measurement Information System (PROMIS)
- Physical function: This item measures self-reported capability rather than actual performance. It includes the functioning of lower extremities (walking or mobility) as well as instrumental activities of daily living, such as running errands. We will use the short form 10b.
- Physical function, upper extremity: This item measures activities that require use of the upper extremity including shoulder, arm, and hand activities. Examples include writing, using buttons, or opening containers. We will use the short form 7.
- Pain Interference: This item assesses self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. We will use the short form 8a.
Short forms will be used in all sites possible (i.e. where the translation is available).
Measured: Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
Patient related outcome / Quality of life 2
EQ-5D-3L assessment (Five items, 3-point categorical scale) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
- The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
Radiological Outcome
Pre-operative/intraoperative
- Deformity parameters (if applicable)
- Nonunion classification: Hypertrophic, Oligotrophic, Atrophic Follow-up visits
- Bone healing (based on the treating physician's judgement): Not healed / Partially healed / Mostly healed / Healed
- Evaluation of the expansion of the bone defect: bone defect size
- Time to healing: Date when full healing is achieved (to be calculated days from index surgery)
Measured: Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start3 Jul 2024
- Primary completion31 May 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans-Christoph Pape, MD, Principal investigator, University Hospital Zurich Department of Trauma Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112992
- Sponsor's protocol ID
- LoBoDe Registry
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2019
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects
- ClinicalTrials.gov ID
- NCT04112992
- Acronym / sponsor ID
- LoBoDe Registry
- Conditions
- Limb Fracture, Bone Loss
- Keywords
- long bone defect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a traumatic bone defect in any long bone
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Skeletally mature
- Post traumatic bone defect > 2 cm either
- Informed consent obtained, i.e.:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any treatment that is used for a defect of any long boneAny 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. | Procedure or surgery | – |
Primary outcome
Baseline characteristics
Time frame: Pre-operative
Demographics, medical history, comorbidity
Bone defect details
Time frame: Pre-operative and/or intraoperative
* 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
Trauma assessment
Time frame: Pre-operative and/or intraoperative
* 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
evaluate the bone defect in the context of previous interventions
Time frame: Intraoperative
Number of previous interventions: <2, <4, >4
Surgical details & Intraoperative findings 1
Time frame: Intraoperative
* Procedure type: * One stage * Staged (e.g. Masquelet technique / distraction osteogenesis / bone transport) * Ilizarov * Bone quality (good, fair, poor) by surgeon's discretion * Soft tissue and vascularity (good, fair, poor) by surgeon's discretion * Contamination (yes/no) Specification: * Metal from a bullet * Metal from a pole * Other Metal * Wood * Soil * Others * Surgical time (min) * Stabilization technique: Internal device (extra- or intramedullary) / External device (For both, drop down menu will be used)
Surgical details & Intraoperative findings 2
Time frame: Intraoperative
* Bone grafting * Autografts * Allograft(s) * Other synthetics * If applicable - time to harvest graft (in minutes) * Graft enhancement yes / no * Demineralized bone matrix (DBM) * Bone morphogenetic protein (BMP) * Stem cells * Platelet rich plasma (PRP) * Other * Soft-tissue / vascular / microsurgical procedure yes / no * Skin graft * Local flap * Free flap * Additional treatment * Systemic antibiotic treatment yes / no * Local antibiotic treatment yes / no * Post-operative use of a negative pressure dressings (NPWT) or vacuum-assisted closure (VAC) system yes / no
Functional Outcome
Time frame: 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 12 months)
- Assessment of limb function and loss of length * Definition: anatomic shortening of the limb in comparison to the contralateral side * Assessment in cm * Any orthotic used to equalize leg length
Patient related outcome / Quality of life 1
Time frame: Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
Patient-Reported Outcomes Measurement Information System (PROMIS) * Physical function: This item measures self-reported capability rather than actual performance. It includes the functioning of lower extremities (walking or mobility) as well as instrumental activities of daily living, such as running errands. We will use the short form 10b. * Physical function, upper extremity: This item measures activities that require use of the upper extremity including shoulder, arm, and hand activities. Examples include writing, using buttons, or opening containers. We will use the short form 7. * Pain Interference: This item assesses self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. We will use the short form 8a. Short forms will be used in all sites possible (i.e. where the translation is available).
Patient related outcome / Quality of life 2
Time frame: Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
EQ-5D-3L assessment (Five items, 3-point categorical scale) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. o The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Radiological Outcome
Time frame: Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
Pre-operative/intraoperative * Deformity parameters (if applicable) * Nonunion classification: Hypertrophic, Oligotrophic, Atrophic Follow-up visits * Bone healing (based on the treating physician's judgement): Not healed / Partially healed / Mostly healed / Healed * Evaluation of the expansion of the bone defect: bone defect size * Time to healing: Date when full healing is achieved (to be calculated days from index surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hans-Christoph Pape, MD principal investigator
University Hospital Zurich Department of Trauma Surgery
21 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Fracture and Bone Loss, run by AO Innovation Translation Center at 21 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, United States, Colombia, Netherlands, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Minoia (+41 79 612 09 67, marco.minoia@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline characteristics (time frame: Pre-operative). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.