Effect of rhBMP-2 or rhBMP-7 on Long Bone Fractures and Non-unions.

Study Overview
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Brief Summary
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Delayed fracture healing continues to cause significant patient morbidity and economic burden to society. Biological stimulation of acute fractures and non-unions includes application of rhBMP-2 and rhBMP-7. However, BMP use continues to be a matter of controversy as literature shows scarce evidence for treatment effectiveness. The aim of this study is to compare acute fractures and non-unions in the long bones humerus, femur and tibia with and without BMP treatment of acute fractures. Furthermore, the investigators want to identify complications and risk factors on union-rate and time to union.

Detailed Description
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Primary Objective: The primary objective is to assess time to union and union rate after rhBMP-2 and rhBMP-7 application at long bone fractures and non-unions. Secondary Objective(s): Analysis of secondary complications Analysis of risk factors Hypothesis and Statistical considerations and estimated enrollment: The investigators hypothesize that with the use of rhBMP-2 and rhBMP-7 there will be a faster timer to union and higher union rate compared to no-BMP. Outcomes will be assessed prospectively. This study is exploratory in nature. Therefore, there is no formal statistical hypothesis and no formal sample size calculation. Approximately 150 long-bone fractures and non-unions are expected. Data will be analyzed with the use of simple summary statistics. Depending on the volume and quality of the collected data, different statistical analyses will be applied. Exploratory analyses will be conducted to investigate relationships between the different treatment options and the outcomes.

Official Title
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Effect of rhBMP-2 or rhBMP-7 on Long Bone Fractures and Non-unions.

Conditions
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Long Bone Non-union

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Long bone fracture or long bone non-union. Signed informed consent, if required by IRB/EC Exclusion Criteria: Prisoner at date of inclusion

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rhBMP-2 and rhBMP-7<br>patients who have been treated with rhBMP-2 or rhBMP-7 for long bone non-union or acute fractures | |
| No-BMP<br>patients who have been treated with standart care, i.e. non-union resection and autologous bone graft | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Union | Time to Union in months | 24 months | 
| Union-rate | Union-rate in percentage | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factor analysis | Clinically relevant retrospective data regarding medical history, co-morbidity, the localization and the outcome will be collected. Comorbidities are listed and categorized as follows: Cardiovascular (peripheral arterial disease, hyperuricemia, coronary artery disease, bleeding disorders, hemophilia A, thrombocytopenia, blood loss anemia), metabolic (diabetes, adiposities, hypertonia, metabolic syndrome, liver disorders, alcoholic liver cirrhosis, alcohol abuse, hypothyroidism, hyperkalemia), neurologic (Parkinson, borderline personality, suicidality, epilepsy, drug abuse, sleep apnea syndrome, status post apoplexy), rheumatologic and allergic (atopic eczema, rheumatoid arthritis, bronchial asthma, chronic bronchitis) and infectious (MRSA, hepatitis A, B and C). | 24 months | 
| complications/Adverse Events related to implant or surgery | complications/Adverse Events related to implant or surgery | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long bone non-union