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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- Changes in active and passive knee flexion ROM measured by analysis.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned unilateral TKA done at Verdun Hospital.
- •Capacity to communicate in French or English.
排除标准
- •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.
研究组 & 干预措施
Hyperbaric gaseous cryotherapy group
Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy
干预措施: Cryoton ™ (Device)
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.
干预措施: Control ice bag (Device)
结局指标
主要结局
Changes in active and passive knee flexion ROM measured by analysis.
时间窗: 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
次要结局
- 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.)
- Length of the stay in hospital ward was measured by the length(in days) of inpatient episode of care.(Participants will be followed for the duration of hospital stay, an expected average of 3 days.)
- Active and passive knee flexion ROM measured using goniometry.(During the first 2 days after surgery.)
- 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.)
- 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.)