Treatment of perioperative swelling by Rest, Ice, Compression and Elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with an unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized pilot-trial

Treatment of perioperative swelling by Rest, Ice, Compression and Elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with an unilateral ankle fracture: study protocol for a monocentric, evaluator-blinded randomized pilot-trial - The RICE vs RICE+ trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023739

Enrollment

Registered

2020-12-14

Start date

2021-07-08

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unilateral closed ankle fracture /

Interventions

Group 1: Extended physical therapy after surgical treatment of an unilateral closed ankle fracture according to the RICS-concept with additional application of negative pressure therapy (RICE+) (Study

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: unilateral closed ankle fracture with indication for surgical fixation BMI =16kg/m2 and <35 kg/m2 omnivore or lacto-ovo-vegetarian diet acceptance for being randomized

Exclusion criteria

Exclusion criteria: open or bilateral ankle fracture history of secondary lymphedema due to tumoral disease within the last 5 years pregnancy dietary patterns other than omnivore or lacto-ovo-vegetarian (e.g. vegan, macrobiotic) incapability to adhere to follow-up examinations

Design outcomes

Primary

Measure	Time frame
The postoperative swelling at time of discharge and after normalization to the healthy leg should bei in patients of the RICE+ and RICE-group 1.2±0.2 vs 1.4±0.2.	—

Secondary

Measure	Time frame
need for analgesics beyond the ones routinely prescribed during postoperative recovery individual perception of pain (numeric rating scale) Follow-up examinations at time of discharge from the hospital up to 12 weeks afterwards: mobility of the affected joint relative to the healthy site at time of discharge from the hospital cadence, gait velociy and the factor of imbalance (gait symmetry) at time of discharge and 2, 4, 6 and 12 weeks afterwards Calcium accrual to bone during fracture healing (concentration of the naturally occurring stable (non-radioactive) Ca-isotopes 44Ca and 42Ca in serum and urine)	—

Measure

Time frame

need for analgesics beyond the ones routinely prescribed during postoperative recovery individual perception of pain (numeric rating scale) Follow-up examinations at time of discharge from the hospital up to 12 weeks afterwards: mobility of the affected joint relative to the healthy site at time of discharge from the hospital cadence, gait velociy and the factor of imbalance (gait symmetry) at time of discharge and 2, 4, 6 and 12 weeks afterwards Calcium accrual to bone during fracture healing (concentration of the naturally occurring stable (non-radioactive) Ca-isotopes 44Ca and 42Ca in serum and urine)

—

Countries

Germany

Contacts

Public ContactThomas Mittlmeier

Zentrum für operative Medizin,, Abteilung für Unfall-, Hand- und Wiederherstellungschirurgie

thomas.mittlmeier@med.uni-rostock.de0381 - 4 94 6051

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 20, 2026