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

Long Bone Non-union Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065684
• Other study ID #: Effect of rhBMP-2 or rhBMP-7
• Status: Completed
• Start date: January 2005
• Est. completion date: January 2012

Study information

• Verified date: August 2021
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Long Bone Non-union

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Union	Time to Union in months	24 months
Primary	Union-rate	Union-rate in percentage	24 months
Secondary	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
Secondary	complications/Adverse Events related to implant or surgery	complications/Adverse Events related to implant or surgery	24 months