NCT05065684

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

May 10, 2023

Status Verified

August 1, 2021

Enrollment Period

7 years

First QC Date

September 13, 2021

Last Update Submit

May 9, 2023

Conditions

Long Bone Non-union

Keywords

Long bone non-union

Outcome Measures

Primary Outcomes (2)

  • Time to Union

    Time to Union in months

    24 months

  • Union-rate

    Union-rate in percentage

    24 months

Secondary Outcomes (2)

  • Risk factor analysis

    24 months

  • complications/Adverse Events related to implant or surgery

    24 months

Study Arms (2)

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-BMP

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an acute fracture or non-union of a long-bone

You may qualify if:

  • Long bone fracture or long bone non-union.
  • Signed informed consent, if required by IRB/EC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Michael J. Raschke, Prof. Dr.

    University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

October 4, 2021

Study Start

January 1, 2005

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 10, 2023

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share