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

Completed

• Conditions: Long Bone Non-union

• Registration Number: NCT05065684
• Lead Sponsor: University Hospital Muenster

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2021-08
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-04
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Union	24 months	Time to Union in months
Union-rate	24 months	Union-rate in percentage

Secondary Outcome Measures

Name	Time	Method
complications/Adverse Events related to implant or surgery	24 months	complications/Adverse Events related to implant or surgery
Risk factor analysis	24 months	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).