Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cryoton ™
Control ice bag
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total knee replacement, Cold, Neurocryostimulation, CO2 cryotherapy, mobility
Eligibility Criteria
Inclusion Criteria:
- Planned unilateral TKA done at Verdun Hospital.
- Capacity to communicate in French or English.
Exclusion Criteria:
- Complications during or after the surgery.
- Inability to perform the tests due to other diseases.
- Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hyperbaric gaseous cryotherapy group
Control ice bag group
Arm Description
Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy
Conventional rehabilitation with ice bag cryotherapy. Application of a bag of crushed ice directly on the anterior aspect of the knee.
Outcomes
Primary Outcome Measures
Changes in active and passive knee flexion ROM measured by analysis.
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
Secondary Outcome Measures
Active and passive knee flexion ROM measured using goniometry.
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.
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)
Calculated as the difference of pain between day 2 and day 1.
Feasibility was assessed by analysis of presence of adverse effects.
Determine if the patients where having or not adverse during thier stay.
Feasibility was assessed by adherence to the intervention (attrition).
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.
Length of stay in hospital ward.
Full Information
NCT ID
NCT02516280
First Posted
July 27, 2015
Last Updated
August 4, 2015
Sponsor
Centre Hospitalier de Verdun
Collaborators
Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT02516280
Brief Title
Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Verdun
Collaborators
Université de Montréal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Total knee replacement, Cold, Neurocryostimulation, CO2 cryotherapy, mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric gaseous cryotherapy group
Arm Type
Experimental
Arm Description
Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy
Arm Title
Control ice bag group
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation with ice bag cryotherapy. Application of a bag of crushed ice directly on the anterior aspect of the knee.
Intervention Type
Device
Intervention Name(s)
Cryoton ™
Other Intervention Name(s)
Neurocryostimulation, Cryonic
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control ice bag
Other Intervention Name(s)
ice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in active and passive knee flexion ROM measured by analysis.
Description
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
Time Frame
Between post-operative day 1 and 2
Secondary Outcome Measure Information:
Title
Active and passive knee flexion ROM measured using goniometry.
Description
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.
Time Frame
During the first 2 days after surgery.
Title
Knee pain measured by visual analog scale.
Description
Scale from 0 to 10 cm on a ruler where 0 represented no pain and 10 represented the worst pain imaginable.
Time Frame
During the first 2 days after surgery.
Title
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)
Description
Calculated as the difference of pain between day 2 and day 1.
Time Frame
Between day 1 and 2.
Title
Feasibility was assessed by analysis of presence of adverse effects.
Description
Determine if the patients where having or not adverse during thier stay.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Title
Feasibility was assessed by adherence to the intervention (attrition).
Description
Determine if the patients where adhering to treatment (drop-off).
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Title
Length of the stay in hospital ward was measured by the length(in days) of inpatient episode of care.
Description
Length of stay in hospital ward.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned unilateral TKA done at Verdun Hospital.
Capacity to communicate in French or English.
Exclusion Criteria:
Complications during or after the surgery.
Inability to perform the tests due to other diseases.
Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Moreau, MSc
Organizational Affiliation
Centre Hospitalier de Verdun
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Results Reference
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Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study
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