Clinical trial NCT02516280: Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Total knee replacement
Cold
Neurocryostimulation
CO2 cryotherapy
mobility
Lead sponsor: Centre Hospitalier de Verdun
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2015-08-05
Enrollment: 65
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in active and passive knee flexion ROM measured by analysis.
timeFrame: Between post-operative day 1 and 2
Secondary outcomes:
measure: Active and passive knee flexion ROM measured using goniometry.
timeFrame: During the first 2 days after surgery.
measure: Knee pain measured by visual analog scale.
timeFrame: During the first 2 days after surgery.
measure: 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)
timeFrame: Between day 1 and 2.
measure: Feasibility was assessed by analysis of presence of adverse effects.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
measure: Feasibility was assessed by adherence to the intervention (attrition).
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
measure: Length of the stay in hospital ward was measured by the length(in days) of inpatient episode of care.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier de Verdun
name: David Moreau, MSc
role: PRINCIPAL_INVESTIGATOR
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