Based on the risk-factors a prediction model for non-union will be developed. Also the effect of a initial vitamin D deficiency on fracture healing will be investigated.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is non union, defined as no full consolidated
fracture after 9 months or in case additional surgery has been performed
earlier due to insufficient fracture healing.
Secondary outcome
Investigate the effect of vitamin D status / deficiency on fracture healing; on
the development of delayed or non-union.
Background summary
Delayed-union or non-union is a complication during fracture healing which is
associated with prolonged fracture treatment and often requires additional
therapy. The incidence of non-union is around 10%. In literature several
risk-factors are identified, in whereby the effect of vitamin D deficiency is
relative unknown. Although these risk-factors are known, no prediction model
has been developed in order to identify the fractures at risk for delayed or
non union. A prediction model allows clinician to interfere early in fracture
treatment in order to prevent prolonged follow up, additional treatment with de
accompanied negative consequences for the patient.
Study objective
Based on the risk-factors a prediction model for non-union will be developed.
Also the effect of a initial vitamin D deficiency on fracture healing will be
investigated.
Study design
Prospective cohort investigation in 3 level 1 trauma centra.
Study burden and risks
Participation in the study involves filling out a questionnaire (5-10 minutes)
once, and obtaining a blood sample once. There are minimal risks associated
with the vena puncture.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
age 18-70 years
Diaphyseal fractures of the clavicle, humerus, fore-arm, femur or lower leg.
Initial trauma X-rays available.
Exclusion criteria
- Re-fracture; pathological fracture, more than one diaphyseal fracture
- Additional injury with an abbreviated Injury Scale (AIS) grade * 2
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL60175.058.17 |