Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized controlled pilot trial

Table 2 Time schedule of the study examinations

	Screening	The day before surgery	Postoperative period starting day 2			Follow-up (weeks 2, 4, 6)	Final visit (week 12)
	Screening	The day before surgery	Daily until discharge	Every 2nd day	Discharge	Follow-up (weeks 2, 4, 6)	Final visit (week 12)
Inclusion/exclusion criteria	x
Informed consent	x
Demographic and medical history	x
Food Frequency Questionnaire ¹⁷		x				x^a	x
Baseline laboratory test^b		x			x		x
Serum/urine sampling^c		x		x	x	x	x
Scoring of BMD^d		x			x		x
Ankle swelling		x	x		x	x	x
Demand for analgesics		x	x		x	x	x
Pain perception (NAS)		x	x		x	x	x
Range of motion					x	x	x
Walking abilities					x	x	x

^aPart of the follow-up examinations at week 4 only
^bRoutinely performed serum analysis (thyroid hormones, renal and liver function, clotting test, blood cell count) plus the determination of parathyroid hormone, 25-hydroxy vitamin D, total and ionized serum calcium, and phosphate
^cDetermination of δ^44/42Ca (serum and urine), fetuin-A (serum), and FGF-23 (serum)
^dBone mineral density will be scored as normal, osteopenic, or osteoporotic by utilization of quantitative pulse echography (Bindex ®, Bone Index Finland Ltd., Kuopio, Finland)

ISSN: 2055-5784