Tibial Fracture Clinical Trial
Official title:
Vitamin D Supplement for Patients With Tibial Fracture Treated With an External Ring Fixator. A Prospective Randomized Double-blind Study.
The purpose is to study:
1. the frequency of vitamin D deficiency at patients with tibial fracture treated with an
external ring fixator
2. if vitamin D supplement facilitates fracture healing
3. a possible relation between vitamin D deficiency and the risk of complications and the
time of fracture healing
External ring fixator is a widespread and well-known method to treate complex tibial
fractures. The effect of treating proximal and distal intra-articulatio tibial fractures has
been positive until now.
Complications such as malunions, nonunions, re-fractures and extended time of ring fixation
will occur in 5-10% of all tibial fractures in patients treated with ring fixator. Factors
like trauma of soft tissue, smoking and compromised afflux of blood are associated with a
higher frequency of nonunion.
It has been documented that elderly people with hypovitaminosis D have a higher risk of
being affected by osteoporosis and fractures. Furthermore, there is a possible association
between the severity of fracture and hypovitaminosis. The time of fracture healing is also
extended compared to fractures in patients who are not affected by osteoporosis.
Until now research has not shown whether the fracture healing process is influenzed by
vitamin D.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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