Preoperative Treatment of Malleolar Fractures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Study of In-cast Intermittent Pneumatic Foot-compression in the Preoperative Treatment of Malleolar Fractures

Conditions
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Ankle Fractures, Intermittent Pneumatic Compression, Comparative Study, Preoperative Care

Intervention / Treatment
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* Device: Flowtron ACS800
* Other: Bandage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malleolar fracture requiring surgery. Exclusion Criteria: Severe arteriosclerosis. Known or suspected acute DVT or flebit. Severe decompensated heart failure. Pulmonary embolism. Acute skin conditions as dermatitis, infected wounds or recent skintransplant. Open fracture. Inability and/or unable to comply with treatment regime and/or to attend postoperative ambulatory follow-up. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPC and bandage<br>Pneumatic device and bandage | Device: Flowtron ACS800<br>* Flowtron ACS800 and bandage<br>Other: Bandage<br>* Bandage only<br>|
| Active Comparator: Bandage only<br>Bandage only | Other: Bandage<br>* Bandage only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from diagnosis-to-surgery |  | 5 days |