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

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.

Primary Objective:
To examine the effect of pre-operative 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 or sinus tarsi approach.

Secondary Objective(s):
1) To examine the effect of pre- and post-operative cooling versus pressure
bandage on the level of pre- and postoperative pain in adult patients who
sustained a DIACF.
2) To examine the effect of pre- and postoperative cooling versus pressure
bandage on preoperative and postoperative swelling in adult patients who
sustained a calcaneal fracture.
3) To examine the effect of pre- and postoperative cooling versus pressure
bandage on foot/ankle circumference in adult patients who sustained a DIACF.
4) To examine the effect of postoperative cooling versus pressure bandage on
postoperative hospital length of stay in adult patients who sustained a
calcaneal fracture.
5) To examine patient satisfaction with the approach to reduce swelling
(cooling versus pressure bandage) in adult patients who sustained a calcaneal
fracture.
6) To examine the effect of pre- and postoperative cooling versus pressure
bandage on the rate of complications in adult patients who sustained a
calcaneal fracture.

Multicenter Randomized Controlled Trial (RCT)

Patients will be equally randomized to two groups:
1) Computer-controlled cooling brace
2) Pressure bandage

The intervention and control treatment are both standard of care, which
generally includes hospital admission. The follow-up program (outpatient
department visits, physical examination, and diagnostics) is standard for the
targeted population.
From enrolment until surgery, patients will be subjected daily to: 1) 5x
completion of pain question; 2) digital photo of affected foot
From enrolment until surgery, patients will also be subjected day 1 and 2 and
then every second day to: 1) duplicate measurement of foot/ankle circumference
on both sides; 2) duplicate measure of foot/ankle volume on both sides;
At day 2 and 7 postoperative, patients will be subjected to: 1) 1x completion
of pain question; 2) duplicate measurement of foot/ankle circumference; 3)
duplicate measure of foot/ankle volume; 4) digital photo of affected foot.
On the day of surgery and day 7 after surgery, patients will complete a VAS for
patient satisfaction with the approach to reduce swelling.
Follow-up data will be collected daily from hospital admission until discharge,
and at two weeks, six weeks, and three months after primary surgery. At each
visit, patients will be subjected to: 1) 1x completion of pain question; 2)
duplicate measurement of foot/ankle circumference; 3) duplicate measure of
foot/ankle volume; 4) digital photo of affected foot.
Therefore there is no additional risk for patients participating in this study.
The risk for study participants is the same as for patients who do not
participate