Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study

August 4, 2015 updated by: Centre Hospitalier de Verdun

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • Neurocryostimulation
  • Cryonic
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 Names:
  • ice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between post-operative day 1 and 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the first 2 days after surgery.
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.
During the first 2 days after surgery.
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.
Between day 1 and 2.
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.
Participants will be followed for the duration of hospital stay, an expected average of 3 days.
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).
Participants will be followed for the duration of hospital stay, an expected average of 3 days.
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.
Participants will be followed for the duration of hospital stay, an expected average of 3 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Verdun

Collaborators

Université de Montréal

Investigators

  • Principal Investigator: David Moreau, MSc, Centre Hospitalier de Verdun

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHV2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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