Effect of Computer-Controlled Cooling on Surgical Aspects after a Displaced Intra-Articular Calcaneal Fracture (Cool-DIACF); A Multicenter Randomized Controlled Trial

BACKGROUND
Displaced intra-articular calcaneal fractures (DIACF) are challenging to treat and are associated with a long rehabilitation period. As the incidence shows a peak in persons in their wage-earning population, the burden to society is high. Surgery should be done as soon as possible. Timing of surgery is mostly determined by the amount of swelling that occurs after trauma. Swelling occurring after surgery may increase the risk of disturbed wound healing and prolong hospital length of stay. Cooling devices have been developed in order to reduce preoperative and postoperative swelling. Furthermore cooling may reduce the need for analgesics. Cooling is expected to result in earlier surgery, shorter hospital length of stay and earlier mobilization, which in turn reduces the risk of adverse events.



AIM
The primary aim of this study is to examine the effect of preoperative cooling versus pressure bandage on the time to surgery in adult patients who sustained a displaced intra-articular calcaneal fracture (DIACF) that will be treated operatively using an extended lateral approach.
The secondary aims are to examine in these patients:

1) the effect of preoperative and postoperative cooling versus pressure bandage on the level of preoperative and postoperative pain.

2) the effect of preoperative and postoperative cooling versus pressure bandage on preoperative and postoperative swelling.

3) the effect of preoperative and postoperative cooling versus pressure bandage on foot/ankle circumference.

4) the effect of postoperative cooling versus pressure bandage on postoperative hospital length of stay.

5) patient satisfaction with the approach to reduce swelling (cooling versus pressure bandage).

6) the effect of preoperative and postoperative cooling versus pressure bandage on the rate of complications.



STUDY DESIGN
Multicenter Randomized Controlled Trial (RCT)



POPULATION
Adult persons aged 18 years or older presenting to the Emergency Department with a unilateral, displaced, intra-articular calcaneal fracture (Sanders type III/V or OTA type 82C24), with an indication for treatment by open reposition and internal fixation (ORIF) using an extended lateral approach.



INTERVENTION
Patients will be equally randomized to two groups:

1) Computer-controlled cooling brace

2) Pressure bandage

ENDPOINTS
Primary outcome measure: Time to surgery
Secondary outcome measures: Preoperative and postoperative pain; Preoperative and postoperative swelling; Preoperative and postoperative foot/ankle circumference; Postoperative hospital length of stay; Satisfaction with the approach to reduce swelling; Adverse events within three months after surgery

Data will be collected daily from hospital presentation until day 7 after surgery and at 2 weeks, 6 weeks, and 3 months after surgery.



RECRUITING COUNTRIES
The Netherlands

We expect that preoperative and postoperative cooling will reduce swelling faster, reducing the time to surgery and time to discharge, respectively.

Daily from hospital presentation until day 7 after surgery and at 2 weeks, 6 weeks, and 3 months after surgery.

Patients in the group will be treated with a computer-controlled cooling brace. The control group will receive a pressure bandage without cooling.