A Psychometric Analysis of the Arabic Version of Oxford Knee Score Before and After Total Knee Arthroplasty in a Middle East Population and an Exploration of Outcomes Post-total Knee Arthroplasty in the Middle East
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Performance based measurements change in Timed up-and-go test
研究概览
简要总结
The intention is to explore whether there are factors, which can help us to understand why some patient outcomes, following total knee arthroplasty are not successful and identify prediction factors for progression. Assessment of outcomes pre- and post-surgery with objective tools is a way to explore prediction tools for good/poor progression and improve patient selection and timing for surgery.
The first aim of this project is determine the psychometric properties of the Arabic Version of Oxford Knee Score, including internal consistency, reliability and validity before and post-total knee arthroplasty in both males and females in a Middle East population. The second aim is to assess the reliability of the Star Excursion Balance Test for measuring the dynamic balance. The final aim is explore outcomes post-total knee arthroplasty among Middle East patients using the Arabic Version of Oxford Knee Score, physical activity measures and performance-based measurements such as: 30 s chair-stand test, stair-climb test, timed up-and-go test and a 6 m walk test while adhering to Osteoarthritis Research Society International recommendations.
详细描述
Project objectives
To gain an understanding of recovery post-TKA in a Saudi population and explore whether there are factors which can help us to understand why some patient outcomes are not successful and identify prediction factors for progression. It is a prospective study measuring outcomes six months post-TKA with the following objectives:
- Examine the internal consistency, reliability and validity of the Arabic Version of Oxford Knee Score before and after total knee arthroplasty in both male and female Middle East patients.
- Examine the test- re-test reliability of the Star Excursion Balance Test in both male and female Middle Eastern patients.
- Measure patient outcomes post-total knee arthroplasty using patient self-reporting activity measurements and the Arabic Version of Oxford Knee Score;
- Evaluate physical activity level improvements post-knee arthroplasty using objective methods and an accelerometer: ActivPAL;
- Assess functional recovery post-knee arthroplasty according to Osteoarthritis Research Society International recommendations using performance-based measurements, such as: 30 s chair-stand test, stair-climb test, timed up-and-go test and a 6 m walk test alongside functional balance.
The rationale which led to this project;
Knee osteoarthritis (OA) is a major cause of disability around the world; it is the most common chronic condition in primary care in the UK. By 2030 it is predicted to be the greatest cause of disability in the general population . An effective end-stage treatment for knee OA is knee-replacement surgery, which was first done in the 1970s and 1980s.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will be asked to participate during preadmission orthopedics clinic visits to King Khalid University Hospital in Riyadh if the patient;
- •Scheduled for elective primary unilateral total knee arthroplasty.
- •For end-stage knee osteoarthritis.
- •In a stable and controlled medical condition,
排除标准
- •Are scheduled for bilateral knee arthroplasty or unilateral knee revision surgery;
- •Cannot read and understand Arabic
- •Have limited function due to musculoskeletal conditions other than unilateral knee osteoarthritis.
- •Have been diagnosed with uncontrolled diabetes mellitus or blood pressure.
- •Have been diagnosed with any neurologic disorders, such as stroke, Parkinson's disease or multiple sclerosis.
- •Are morbidly obese and have a body mass index (BMI) greater than
- •Have advance osteoporosis or some other unstable chronic disease.
- •Have been diagnosed with a peripheral vascular or uncontrolled cardiac disease.
- •Participant will further be excluded post-surgery if they develop any surgical complications, such as deep vein thrombosis, uncontrolled infection or fracture.
结局指标
主要结局
Performance based measurements change in Timed up-and-go test
时间窗: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
The test procedure will use a stopwatch accurate to 1/100 s; a chair of standard 45 cm height, with armrests, will be placed on an outdoor level footpath and a line 3 metres from the chair will be drawn. Patients will be instructed to stand up from the chair, using the arms if required, walk for 3 metres to the line, then turn round and walk to sit back down on the chair as quickly, safely and comfortably as they can. An assessor will start timing as the patient leans forward to stand up, and stop when the patient's hips make contact with the seat to sit down. An average of two repetitions will be analysed (Ko, Naylor, Harris, Crosbie, \& Yeo, 2013; Mizner et al., 2011; Podsiadlo \& Richardson, 1991).
Balance change
时间窗: one week before admission day and 6 months after surgery to assess the balance changes post-surgery
In the Star Excursion Balance Test, three tape measures will be fixed to the clinic floor, one oriented anteriorly to the apex and two aligned at 135° to the anterior tape in the posterolateral and posteromedial directions. (Fullam, Caulfield, Coughlan, \& Delahunt, 2014). The patient will stand in the center of the grid and be instructed to stand on the affected or operated leg while reaching out as far as possible in one of the three directions with the other lower extremity, and then return that leg to the center. The participant will be asked to perform the test barefoot, keeping the heel of the stance leg on the floor at all times and to bend the knee of the stance leg. If the participant does not carry out any of these instructions, the trial will repeated. The assessor will measure the reach distance in each direction in centimeters and then normalize the average of the three trials to leg length.
Physical activity measurements change will be assess using an activPAL activity monitor (PAL Technologies, Glasgow, UK)
时间窗: one week before admission day and 6 months after surgery to assess the physical activity changes post-surgery
an activPAL activity monitor (PAL Technologies, Glasgow, UK) as this proven accelerometer provides objective quantification of free-living physical activity without any modification (Dahlgren, Carlsson, Moorhead, Hager-Ross, \& McDonough, 2010; Schmalzried et al., 1998). It is suitable as it light in weight (20g), includes an inclinometer and is small in size (53 x 35 x 7 mm) Figure 3. The device is worn by patient's mid-thigh, secured by non-allergic waterproof adhesive tape under their clothes, for 7-10 days before surgery and 6 months after. Clear written and verbal instructions will be given to patients as they have to wear it all day and all night except, when bathing or swimming (they can take a shower with it on).
Performance based measurements change in Thirty second chair-stand test
时间窗: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
A chair of 17 inches (45cm) height is used as the starting position for patients sitting with their arms cross the chest. Patients are instructed to stand and then sit with good buttock placement and back support, their hands on arm rests and feet correctly placed, then stand again as fast and safely as they can. The assessor counts the number of complete chair stands within 30 s. The mean of two trials will be used for analysis (Gill \& McBurney, 2008; Unver, Kalkan, Yuksel, Kahraman, \& Karatosun, 2015)
Performance based measurements change in Stair-climb test
时间窗: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
Using a stopwatch accurate to 1/100 s, an assessor will measure the time required for a patient, using a handrail if required, to ascend and descend a flight of twelve steps 18 cm high and 28 cm deep. Patients will be instructed to ascend and descend the stairs as quickly, safely and comfortably as they can. The mean of two trials will be used for analysis (Mizner et al., 2011)
Performance based measurements change in Six minute walk test
时间窗: one week before admission day and 6 months after surgery to assess the performance changes post-surgery
The test will measure how far patients can walk in 6 minutes along a level 25-metre footpath. Patients can use an assistive device if required, take a rest if necessary and have standardized encouragement after each minute. The assessor will ask the patient to stop after 6 minutes. Only one test will be performed to avoid fatigue ("ATS Statement," 2002; Ko et al., 2013; Mizner et al., 2011).
次要结局
- Arabic versions of Oxford Knee Score Reliability assessment(one week before admission day, admission day and 6 months after surgery and to evaluate the construct validity of the Arabic version of Oxford Knee Score)
- Arabic versions of Oxford Knee Score Validity assessment(one week before admission day)
研究者
Bodor Bin sheeha
PhD student at University of Salford
University of Salford