Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01955577
Study type Interventional
Source Northern Orthopaedic Division, Denmark
Contact Christian Cavallius, M.D.
Email christian.cavallius@rn.dk
Status Not yet recruiting
Phase Phase 1
Start date April 2015
Completion date December 2016

See also
  Status Clinical Trial Phase
Terminated NCT01927575 - Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury N/A
Completed NCT01017094 - Pin Site Infection Prevention for Open Tibial Fracture Phase 3
Completed NCT00038129 - SPRINT - Randomized Trial of Tibial Fracture Fixation N/A
Recruiting NCT01795287 - Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture N/A
Terminated NCT01300520 - The Development of a Surgical Localizing Aid Medical Device N/A
Active, not recruiting NCT05012449 - Transitional Ankle Fracture Management Using a New Joystick Technique N/A
Recruiting NCT04432389 - Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture Phase 2
Suspended NCT00365573 - Doppler Ultrasonography Evaluation of Tibial Fracture Site Vascularity Phase 2
Completed NCT02820363 - Study Evaluating CERAMENTâ„¢|G in Open Diaphyseal Tibial Fractures N/A
Completed NCT00264511 - Hyperbaric Oxygen in Lower Leg Trauma Phase 2/Phase 3
Completed NCT04028908 - Remodelling After Trampoline Fracture in Children
Completed NCT02140528 - Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures Phase 2
Active, not recruiting NCT03598530 - Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
Completed NCT00250302 - Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures Phase 1/Phase 2
Unknown status NCT02035917 - Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate N/A