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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline characteristics | Demographics, medical history, comorbidity | Pre-operative |
| Bone defect details |
| Pre-operative and/or intraoperative |
| Trauma assessment |
| Pre-operative and/or intraoperative |
| evaluate the bone defect in the context of previous interventions | Number of previous interventions: <2, <4, >4 | Intraoperative |
| Surgical details & Intraoperative findings 1 |
Specification:
|
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Inclusion Criteria:
Age ≥ 18 years
Skeletally mature
Post traumatic bone defect > 2 cm either
Informed consent obtained, i.e.:
Exclusion Criteria:
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Patients with a traumatic bone defect in any long bone
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Minoia | Contact | +41 79 612 09 67 | marco.minoia@aofoundation.org | |
| Joelle Kägi | Contact | +41 79 549 32 83 | joelle.kaegi@aofoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Hans-Christoph Pape, MD | University Hospital Zurich Department of Trauma Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedar Sinai | Recruiting | Los Angeles | California | 90048 | United States |
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| Intraoperative |
| Surgical details & Intraoperative findings 2 |
| Intraoperative |
| Functional Outcome | - Assessment of limb function and loss of length
| 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)
Short forms will be used in all sites possible (i.e. where the translation is available). | 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. 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. | Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months) |
| Radiological Outcome | Pre-operative/intraoperative
| Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months) |
| Sinai Hospital of Baltimore | Recruiting | Baltimore | Maryland | 21215 | United States |
|
| John Hunter Hospital | Recruiting | Newcastle | 2310 | Australia |
|
| Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia | Recruiting | Rio de Janeiro | 22430-160 | Brazil |
|
| Hospital Base Valdivia | Recruiting | Valdivia | 5090146 | Chile |
|
| Hospital Universitario de la Samaritana | Suspended | Bogotá | 110411 | Colombia |
| Hospital Pablo Tobon Uribe | Recruiting | Medellín | Colombia |
|
| University Hospital Frankfurt | Recruiting | Frankfurt | Germany |
|
| Universitätsspital Gießen | Recruiting | Giessen | 35385 | Germany |
|
| Universitätsklinikum Heidelberg (Unfallchirurgie) | Terminated | Heidelberg | Germany |
| Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie) | Recruiting | Münster | Germany |
|
| Krankenhaus Johanneum | Not yet recruiting | Wildeshausen | 27793 | Germany |
|
| Paras HMRI Hospital Patna | Recruiting | Patna | 800014 | India |
|
| Academisch Ziekenhuis Maastricht (Dept. of Surgery) | Recruiting | Maastricht | Netherlands |
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| Radboud University Medical Center | Recruiting | Nijmegen | 6525 | Netherlands |
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| Tygerberg Hospital | Not yet recruiting | Cape Town | 7505 | South Africa |
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| Kyungpook National University Hospital (Orthopaedics) | Recruiting | Daegu | South Korea |
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| Universitätsspital Zürich (Klinik für Traumatologie) | Recruiting | Zurich | Switzerland |
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| Central Hospital of Border Guard Service of Ukraine | Not yet recruiting | Kyiv | Ukraine |
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| Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery) | Not yet recruiting | Leeds | United Kingdom |
|
| Hospital Universitario de Caracas | Not yet recruiting | Caracas | Venezuela |
|
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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