Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

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.
    

Detailed description: 
      Background: After total knee arthroplasty (TKA), patients can be discharged from hospital as
      early as two days after surgery. However, patients often do not achieve functional knee
      flexion range of motion (ROM) in the first postoperative days. Early application of
      hyperbaric gaseous cryotherapy (HGC) at the operated knee within an hour after surgery and
      the next postoperative days might increase ROM by reducing inflammation, edema and pain.
      However, it is unclear whether such early application of HGC is feasible. Moreover, there is
      no data to allow calculation of the sample size required to conduct a randomized controlled
      trial to compare the effects of HGC to those of conventional cryotherapy on the increase of
      knee flexion in the first two days after TKA.

      Objectives: To investigate the feasibility of applying HGC within an hour after TKA and twice
      a day the next postoperative days. To collect data on changes in knee flexion ROM in the
      first two postoperative days to calculate the sample size required for a large randomized
      controlled trial. To compare the effects of HGC to those of conventional cryotherapy on
      changes in knee flexion ROM in the first two postoperative days.

      Design: A prospective, single-blinded, randomized, controlled pilot trial.

      Setting: Orthopedic postoperative unit in an acute care hospital.

      Interventions: Patients were randomly allocated to either hyperbaric gaseous cryotherapy
      (intervention group) or the ice bag cryotherapy (control group). In each group, participants
      received the specific cryotherapy intervention at the operated knee within an hour after the
      surgery (day 0) and twice the next two postoperative days (day 1 and day 2).

      Outcome measures: Feasibility measures included the rate of eligible patients who were
      willing to participate, attrition, adherence to interventions and presence of adverse
      effects. Active and passive knee flexion range of motion (ROM) and knee pain intensity at
      rest were evaluated on postoperative days 1 and 2. Change in active and passive knee flexion
      ROM and in knee pain intensity at rest from postoperative day 1 to day 2 were assessed.
      Length of hospital stay was collected.
    

Intervention name(s): Cryoton ™; Control ice bag
Intervention type(s): Device; Device
Intervention description(s): 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.
Other intervention name(s): Neurocryostimulation; Cryonic; ice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee replacement; Cold; Neurocryostimulation; CO2 cryotherapy; mobility