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

NCT ID: NCT05065684

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Long Bone Non-union

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

rhBMP-2 and rhBMP-7

patients who have been treated with rhBMP-2 or rhBMP-7 for long bone non-union or acute fractures

No interventions assigned to this group

No-BMP

patients who have been treated with standart care, i.e. non-union resection and autologous bone graft

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J. Raschke, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Other Identifiers

Effect of rhBMP-2 or rhBMP-7

Identifier Type: -

Identifier Source: org_study_id