Randomised Controlled Trial Comparing Hospital Inpatient vs Home Rehabilitation After Total Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 6
- 主要终点
- Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT)
研究概览
简要总结
Total knee replacement (TKR) surgery is a common and highly effective treatment option for alleviating the pain and disability caused by chronic arthritis. The associated rehabilitation costs, however, impose a significant burden on the health system. In particular, inpatient rehabilitation - utilised by approximately 43% of private TKR recipients in NSW and 29% Australia-wide is of greatest concern, costing, on average, $7000 (AU) per inpatient episode.
The overarching aim of this study is to establish whether inpatient rehabilitation is necessary after TKR for patients with osteoarthritis (OA) who could otherwise be discharged directly home.
The main hypothesis to be tested by the proposed study is that TKR recipients who receive inpatient rehabilitation in addition to participating in a home programme, compared to patients who participate in a home programme only, will achieve a superior level of mobility. If superiority is shown, a cost-effectiveness analysis will be undertaken.
Secondary hypotheses to be tested relate to patient-reported knee pain and function, health-related quality of life, functional ambulation, and knee joint mobility.
Superiority in these outcomes will be evident at six months after surgery.
详细描述
As preferences for therapy can be a confounder in RCTs, patients will be asked their preference for rehabilitation post TKR, prior to randomisation.
Patients will be randomised once a hospital bed is available.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients presenting for elective, primary, unilateral TKR at the Whitlam Joint Replacement Centre (Fairfield Hospital) will be screened for eligibility at the pre-admission clinic by the study Project Manager (PM).
- •primary diagnosis of OA
排除标准
- •predisposition for requiring prolonged inpatient supervision (eg requiring assistance with at least one personal activity of daily living or lack of social support)
- •inability to comprehend the study protocol.
- •catastrophic complication arising post-surgery which precludes rehabilitation commencing within 2-3 weeks of surgery
结局指标
主要结局
Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT)
时间窗: Pre surgery; 10 weeks, six months and twelve months after surgery.
Functional mobility is a composite of several factors targeted in rehabilitation programs after TKA such as lower limb strength, knee range of motion, and balance. Second, a functional outcome is more likely to be directly influenced by the intervention (rehabilitation), and the intervention aims to improve walking. Third, the 6MWT is highly reproducible within the individual. Fourth, it is likely to be less susceptible to misinterpretation and less culturally sensitive than patient-reported outcomes. Fifth, the test does not appear to suffer from the floor or ceiling effects associated with many patient-reported outcomes. Sixth, an observer-measured outcome is less likely to be influenced by a preference effect compared to a patient-reported outcome, and this is particularly important when the intervention under examination cannot be blinded from the recipient. Together, these attributes mean the results for our primary outcome should be readily translatable to any TKA cohort.
次要结局
- Knee range of motion(Pre surgery; 10 weeks, six months and twelve months after surgery.)
- EQ5D(Pre surgery; 10 weeks, six months and twelve months after surgery.)
- Patient preference for therapy(After consenting to participation and prior to randomisation)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre surgery; 10 weeks, six months and twelve months after surgery.)
- Cost of surgery(Pre surgery; 10 weeks, six months and twelve months after surgery.)
- 15 metre walk test(Pre surgery; 10 weeks, six months and twelve months after surgery.)
研究者
Mark Buhagiar
Manager of Allied Health, Principal Investigator
South West Sydney Local Health District