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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
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Centre Hospitalier de Verdun

Tracking Information
First Submitted Date  ICMJE July 27, 2015
First Posted Date  ICMJE August 5, 2015
Last Update Posted Date August 5, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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.
    Other Names:
    • Neurocryostimulation
    • Cryonic
  • 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
Study Arms  ICMJE
  • Experimental: Hyperbaric gaseous cryotherapy group
    Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy
    Intervention: Device: Cryoton ™
  • 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.
    Intervention: Device: Control ice bag
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2015)
65
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02516280
Other Study ID Numbers  ICMJE CHV2012-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier de Verdun
Study Sponsor  ICMJE Centre Hospitalier de Verdun
Collaborators  ICMJE Université de Montréal
Investigators  ICMJE
Principal Investigator: David Moreau, MSc Centre Hospitalier de Verdun
PRS Account Centre Hospitalier de Verdun
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP