An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects

Conditions
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Limb Fracture, Bone Loss

Intervention / Treatment
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* Procedure: Any treatment that is used for a defect of any long bone


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline characteristics | Demographics, medical history, comorbidity | 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 | 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 | 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 | 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) | 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 | 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 | 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). | 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 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) | Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long bone defect