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

NCT02516280 | Completed

• 1 other identifier: CHV2012-01
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Keywords

Total knee replacement; Cold; Neurocryostimulation; CO2 cryotherapy; mobility

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Active and passive knee flexion ROM measured using goniometry.

  During the first 2 days after surgery.

• Knee pain measured by visual analog scale.

  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)

  Between day 1 and 2.

• Feasibility was assessed by analysis of presence of adverse effects.

  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).

  Participants will be followed for the duration of hospital stay, an expected average of 3 days.

Study Arms (2)

Hyperbaric gaseous cryotherapy group

EXPERIMENTAL

Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy

Device: Cryoton ™

Control ice bag group

ACTIVE COMPARATOR

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

Interventions

Cryoton ™ 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.

Also known as: Neurocryostimulation, Cryonic

Hyperbaric gaseous cryotherapy group

Control ice bag 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.

Also known as: ice

Control ice bag group

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned unilateral TKA done at Verdun Hospital.
• Capacity to communicate in French or English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Verdun: lead
• Université de Montréal: collaborator

Related Publications (58)

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MeSH Terms

Conditions

Osteoarthritis, Knee; Common Cold

Interventions

Cryopreservation; Dental Pulp Test

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques; Diagnosis, Oral; Dentistry

Study Officials

• David Moreau, MSc

  Centre Hospitalier de Verdun

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 5, 2015
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 5, 2015

Record last verified: 2015-08