At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Hyperbaric Gaseous Cryotherapy on Knee Flexion Range of Motion in the First Two Days After Total Knee Arthroplasty: A Feasibility Randomized Controlled Trial
In Brief
A clinical study evaluating Cryoton ™ and Control ice bag for Osteoarthritis, Knee. Completed, enrolled 65 participants.
Detailed Summary
A pilot study was performed to investigate the feasibility of a large randomized controlled trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in knee flexion range of motion in the first two days after total knee arthroplasty.
Study Details
Timeline
Interventions
In the intervention group, participants received hyperbaric gaseous cryotherapy delivered with a Cryoton ™ device (Cryonic Médical, Salins-les-Bains, France) within an hour after the surgery and two times per day the next postoperative days. The tip of the nozzle was kept 10-15 cm above the dry skin as the gaseous CO2 was sprayed on three zones of 5 cm by 10 cm (medial, lateral and posterior, respectively) using a slow and regular sweeping movement for approximately 30 seconds after a skin temperature of 2°C is reached.
In the control group, participants received two 20-minute treatments of cryotherapy within an hour after the surgery and two times per day the next postoperative days. Cryotherapy was performed using an ice bag that was applied directly on the anterior aspect of the knee. The ice bag is a square latex bag of 30 cm by 30 cm filled with crushed ice and wrapped in a thin pillow case. The treatment assessor applied the intervention in a standardized manner by ensuring that the knee was fully extended while covering the surgical incision and both lateral and medial aspects of the knee with the iced bag.