The aim of this project is to determine the possible use of biomarkers for non- or delayed-union in fractures of the diaphyseal femur and tibia.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Circulating levels and corresponding genetic variations of biomarkers are the
primary parameters.
These are compared between patients with normal union and delayed-union.
Secondary outcome
not applicable.
Background summary
After the occurrence of a bone fracture, a significant percentage will heal
within 9 months, the standard time span for fracture healing. However, 5-30% of
fractures will show delayed or non-union. Numerous proteins play a significant
role in bone regeneration, fracture healing and wound healing. Abnormal
circulating levels of these proteins may be associated with the development of
non- or delayed union. Systemic alterations of these proteins which are
detectable in the circulation may serve as biological markers (biomarker) for
the extent and prognosis of fracture healing. Genetic mutations could cause the
impaired expression of proteins leading to abnormal circulating levels.
Study objective
The aim of this project is to determine the possible use of biomarkers for non-
or delayed-union in fractures of the diaphyseal femur and tibia.
Study design
Retrospective, multicentre, cohort study.
Study burden and risks
A total amount of 28.5 ml blood per patient will be drawn once.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Diaphyseal fracture of the tibeal or femoral bone
Exclusion criteria
Legal incapacity
No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31694.058.10 |