Tibial Fracture
Conditions
Keywords
Vitamin D deficiency, Ring fixator, Tibial fracture
Brief summary
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
Detailed description
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.
Interventions
Sponsors
Northern Orthopaedic Division, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with tibial fracture * A written signed statement of consent * All potential patients primary with osteosynthesis Iliazov
Exclusion criteria
* Tumours in bone * Metastases to bone marrow * Chronic renal disease * Drug abuse * Abuse of alcohol (\>21 drinks a week for men and \> 14 drinks a week for women) * Morbus Cushing disease * Glandulae thyroid disease * Pregnancy * Chronic steroid therapy * Hepatic insufficiency * Sarcoidosis, tuberculosis or silocosis * Patients under 18 years * Inability to take medicine * Adverse effects of vitamin D or allergic to vitamin D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of fracture healing | 20 weeks | Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D receptor DNA | 20 weeks | A DNA blood sample will be taken in order to analyse how the skeleton reacts on vitamin D supplement. |
| Complications | 20 weeks | Registration of possible complications, i.e. nonunion, malunion, number of check-ups, infections, re-surgery. |
Countries
Denmark
Contacts
Primary ContactChristian Cavallius, M.D.
Backup ContactJuozas Petruskevicius, M.D., Ph.D.
Outcome results
None listed