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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516280
• Other study ID #: CHV2012-01
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: August 4, 2015
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: August 2015
• Source: Centre Hospitalier de Verdun
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministère santé et services sociaux du Québec
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Verdun	Université de Montréal

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Between post-operative day 1 and 2	No
Secondary	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.	During the first 2 days after surgery.	No
Secondary	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.	During the first 2 days after surgery.	No
Secondary	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.	Between day 1 and 2.	No
Secondary	Feasibility was assessed by analysis of presence of adverse effects.	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.	No
Secondary	Feasibility was assessed by adherence to the intervention (attrition).	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.	No
Secondary	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.	Participants will be followed for the duration of hospital stay, an expected average of 3 days.	No