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

NCT ID: NCT02516280

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hyperbaric gaseous cryotherapy group

Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy

Group Type: EXPERIMENTAL

Cryoton ™

Intervention Type: DEVICE

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 group

Conventional rehabilitation with ice bag cryotherapy. Application of a bag of crushed ice directly on the anterior aspect of the knee.

Group Type: ACTIVE_COMPARATOR

Control ice bag

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Neurocryostimulation; Cryonic; ice

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Verdun

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Moreau, MSc

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Verdun

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Other Identifiers

CHV2012-01

Identifier Type: -

Identifier Source: org_study_id