Ankle Fractures Clinical Trial
Official title:
A Randomized Study of In-cast Intermittent Pneumatic Foot-compression in the Preoperative Treatment of Malleolar Fractures
This study investigates, in a randomized setting, the use of intermittent in-cast pneumatic
foot-compression (IPC) in the preoperative treatment of malleolar fractures. This is to
investigate whether the IPC has any effect on preventing swelling of the ankle, and thereby
preventing delay of surgery due to swelling.
The investigators will include patients with malleolar fractures that require surgery in two
groups, IPC and bandage or bandage only, and measure the time from diagnosis-to-surgery.
Malleolar fractures are often complicated by tissue swelling due to soft tissue injury,
haemorrhage and secondary inflammation.
This can lead to severe oedema which can compromise the ability to perform surgery due to
blister formation or the inability to close the skin after surgery. Studies have shown that
the use of intermittent pneumatic foot-compression (IPC) can reduce waiting time from
diagnosis to surgery as well as reduce length of hospital stay.
Purpose of the study is in a randomized study to investigate whether patients requiring
surgery because of malleolar fractures has a lower diagnosis-to-surgery time when using IPC
than patients not using IPC.
All patients age 18 or above admitted to our hospital with malleolar fractures (AO type
44-A, 44-B, 44-C) requiring surgery, will be randomized to either in-cast IPC or only
cast-immobilization. Time from diagnosis of the fracture(time of the x-ray) until start of
surgery(time of incision) will be the primary outcome. Patients will be seen in a
postoperative ambulatory follow-up at 14 days, 6 weeks, 3 months and 1 year.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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