The Effect of Smart Ring Assisted Physiotherapeutic Intervention on the Risk of Poor Outcome 12 Months After a Total Knee Replacement: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 338
- 试验地点
- 2
- 主要终点
- the proportion of patients with poor postoperative outcome
研究概览
简要总结
The goal of this randomized controlled trial is to learn about the effect of a wearable activity tracker assisted physiotherapeutic intervention on the risk of poor patient reported outcome after a primary total knee replacement.
The main question it aims to answer is whether a wearable activity tracker assisted physiotherapeutic intervention and remote monitoring may help to decrease the number of the poor patient reported post-operative outcome 12 months after a primary total knee replacement.
Participants will receive standard postoperative care which includes physiotherapy appointments 4 weeks and 3 months after the surgery and they will use smart rings (Oura ring) 3 months postoperatively. Patients will be remotely monitored to follow their recovery from total knee replacement surgery: the study group physiotherapists will follow the patients' activity and sleep and if necessary, make a contact with patient if there seems to low activity indicating difficulties with recovering from the surgery.
Researchers will compare the intervention group to a group of participants who will receive only standard postoperative care with physiotherapy appointments 4 weeks and 3 months, to see if the use of the Oura ring may decrease the number of participants with poor patient reported post-operative outcome after total knee replacement.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary TKA for primary osteoarthritis.
- •Patients able to consent and willing to comply with the study protocol.
- •Patients aged 18 to 70 years
- •Patients is able to use a smartphone and a smart ring.
排除标准
- •Patients unwilling to provide informed consent
- •>15 degrees varus or valgus, or > 15 degrees fixed flexion deformity
- •Physical, emotional, or neurological conditions that would compromise the patient, e.g., poor compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions, such as Parkinson, MS, etc.)
- •Patients unable to attend the study physiotherapy appointments at the outpatient clinic.
- •Patients unable to wear Oura ring (example in case of OA or rheumatoid arthritis in the finger joints).
- •Patients with cardiac arrhythmia.
结局指标
主要结局
the proportion of patients with poor postoperative outcome
时间窗: 12 months after total knee replacement surgery
次要结局
- homogeneity of variance in the Oxford Knee Score(12 months after the surgery)
- Oxford Knee Score(12 months after the surgery)
- Forgotten Joint Score 12 (FJS-12)(12 months after the surgery)
- pain while walking using the visual analoque (VAS scale)(12 months after surgery)
- The patient satisfaction VAS(12 months after surgery)
- passive knee range of motion(12 months after surgery)
- patient accepted symptom state questions(12 months after surgery)
- EQ-5D-5L(12 months after the surgery)
- pain at rest using the visual analoque (VAS scale)(12 months after surgery)
- active knee range of motion(12 months after surgery)