Effectiveness of a Community-based Post-operative Rehabilitation and Fall Prevention Program Following Total Knee Arthroplasty - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Chinese version of Knee Injury and Osteoarthritis Outcome Scale
研究概览
简要总结
Knee osteoarthritis (OA) is a common musculoskeletal disorder among older people. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population.
Total knee arthroplasty (TKA) is used to treat patients with severe knee OA. While TKA has been shown to improve knee pain, function and quality of life of patients with knee OA, up to 50% of patients with post-TKA may suffer from falls within in the first year after TKA. Given that Tai Chi can significantly improve the balance and function of older people, a fall prevention program may improve balance, pain, and function of post-TKA patients.
As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA against a group of TKA patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.
详细描述
Osteoarthritis (OA) is the third most disabling musculoskeletal compliant in the world. Knee OA is the most common type of OA. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population.
Total knee arthroplasty (TKA) is a surgical intervention for treating patients with severe knee OA. Research has found that TKA reduces knee pain, and improves patient's function and quality of life. However, studies have also found that patients with post-TKA may be more likely to fall as compared to age- and gender-matched asymptomatic counterparts. It is estimated that around 20% to 50% of patients fall within in the first year after TKA. As such, it is essential to improve the balance of post-TKA patients.
Studies have found that Tai Chi can significantly improve the balance and function of older people. Therefore, a fall prevention program aiming at strengthening, proprioception, balance training, and behavioral modification may improve balance, pain, and function of post-TKA patients.
As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA with a group of patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The orthopedic surgeons, outcomes assessor and statistician will be blinded.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants undergoing TKA for intervention group and usual postoperative care group
- •Age- and gender-matched asymptomatic controls without knee pain in the last 12 months.
- •Can speak and understand Cantonese/English.
排除标准
- •Living in assisted living facilities, requiring nursing care
- •Medical 'red flag' conditions
- •A history of cancer in the last five years
- •Cauda equine syndrome
- •Knee fracture
- •Auto-immune disease (e.g. rheumatoid arthritis) even if they have OA
- •Inflammatory or septic arthritis
- •Systemic disease
- •Amputation
- •History of orthopedic or neurological surgery to the spine, pelvis or hips
- •Neurological diseases (e.g. stroke or Parkinson's disease)
- •Mini-Mental State Examination score < 24
- •Depression subscale score of Depression Anxiety Stress Scales > 21
- •Severe comorbidity leading to severe deterioration of quality of life or major healthcare utilization
- •Osteochondritis dissecans
- •Perthes' disease
- •Plica disease
- •Baker's cyst
结局指标
主要结局
Chinese version of Knee Injury and Osteoarthritis Outcome Scale
时间窗: 1 year
A 42-item questionnaire with 5 subscales to assess pain, symptoms, activities of daily living, sports and recreation function, and knee-related quality of life
次要结局
- Chinese version Falls Efficacy Scale - International(1 year)
- Chinese version geriatric depression scale(1 year)
- Number of post-operative trips/falls(1 year)
- Physical Activity Scale for the Elderly(1 year)
- 11-point numeric pain rating scale(1 year)
- Chinese version Insomnia Severity Index(1 year)
研究者
Dr Arnold Wong Yu Lok
Assistant Professor
The Hong Kong Polytechnic University