Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study
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|ClinicalTrials.gov Identifier: NCT02516280|
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : August 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: Cryoton ™ Device: Control ice bag||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Hyperbaric gaseous cryotherapy group
Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy
Device: Cryoton ™
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.
Active Comparator: Control ice bag group
Conventional rehabilitation with ice bag cryotherapy. Application of a bag of crushed ice directly on the anterior aspect of the knee.
Device: Control ice bag
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 Name: ice
- Changes in active and passive knee flexion ROM measured by analysis. [ Time Frame: Between post-operative day 1 and 2 ]The primary outcomes were changes in active and passive knee flexion ROM from postoperative day 1 to day 2. This outcome was calculated as the difference in active and passive ROM between day 2 and day 1
- Active and passive knee flexion ROM measured using goniometry. [ Time Frame: During the first 2 days after surgery. ]Active and passive knee flexion ROMs were measured with a long-arm (35 cm) goniometer featuring a 360º and two 180º scales, with 1º increments that read in opposite directions (Baseline 360° 14" Goniometer, Fabrication enterprises Inc., NY, USA). Knee ROMs were measured in sitting position because levels of agreement between observers are higher in sitting position than in supine position.
- Knee pain measured by visual analog scale. [ Time Frame: During the first 2 days after surgery. ]Scale from 0 to 10 cm on a ruler where 0 represented no pain and 10 represented the worst pain imaginable.
- Change in pain from postoperative day 1 to day 2 measured by analysis of variation of the recorded pain between data of day2 and day 1 (Knee pain measured by visual analog scale) [ Time Frame: Between day 1 and 2. ]Calculated as the difference of pain between day 2 and day 1.
- Feasibility was assessed by analysis of presence of adverse effects. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days. ]Determine if the patients where having or not adverse during thier stay.
- Feasibility was assessed by adherence to the intervention (attrition). [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days. ]Determine if the patients where adhering to treatment (drop-off).
- Length of the stay in hospital ward was measured by the length(in days) of inpatient episode of care. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days. ]Length of stay in hospital ward.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516280
|Principal Investigator:||David Moreau, MSc||Centre Hospitalier de Verdun|