ORTOMOVE: Protocol for a Prospective Cohort Study Comparing Physical Activity, Sleep Quality and Patient-reported Outcomes Following Same- Day Discharge Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Oxford Knee Score (OKS)
研究概览
简要总结
The goal of this observational study is to examine changes in physical activity, sleep quality, knee extension and flexion strength, knee range of motion, and patient-reported outcomes before and after same-day discharge knee arthroplasty (SDD-KA). The study will also investigate whether these changes are associated with each other and with patient satisfaction. As a prespecified secondary aim, researchers will compare these outcomes between patients undergoing medial unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA).
The main questions it aims to answer are:
- How do physical activity, sleep quality, knee extension and flexion strength, knee range of motion, and patient-reported outcomes change following SDD-KA?
- Are changes in these outcomes associated with each other and with patient satisfaction?
- Are these outcomes different between patients undergoing medial UKA and TKA?
Participants will:
- Wear an accelerometer to measure physical activity and sleep before surgery, continuously from surgery to 3 months after surgery, and again for 2 weeks at 12 months after surgery
- Complete questionnaires about knee function, sleep quality, pain, health-related quality of life, and satisfaction with surgery
- Have knee muscle strength and active knee range of motion assessed before and 12 months after surgery
- Attend follow-up assessments during the 12-month postoperative period
详细描述
This is a prospective observational cohort study investigating postoperative recovery in patients undergoing same-day discharge knee arthroplasty (SDD-KA) for knee osteoarthritis. The primary aim is to characterize pre- to postoperative changes in physical activity, sleep quality, knee extension and flexion strength, knee range of motion, and patient-reported outcomes, and to investigate associations among these changes and their relationship with patient satisfaction.
As a prespecified secondary aim, the study will compare these outcomes between patients undergoing medial unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA). Patients are not randomized to UKA or TKA; the surgical procedure is determined by the treating clinical team according to established clinical indications. The study therefore represents an observational comparison of two patient cohorts undergoing different surgical procedures.
The study will include 120 patients undergoing primary SDD-KA at Turku University Hospital, Finland. The cohort will consist of 30 patients undergoing medial UKA and 90 undergoing TKA. Participants will be followed prospectively from the preoperative period through 12 months after surgery.
Physical activity and sleep will be assessed objectively using wearable accelerometers. Measurements will be performed during a two-week period before surgery, continuously from the time of surgery through 3 months postoperatively, and during a further two-week measurement period at 12 months postoperatively. Accelerometer data will be analysed at the UKK Institute for Health Promotion Research using validated algorithms. Clinical assessments will include isometric knee extension and flexion strength and active knee range of motion. Patient-reported outcomes will include knee-specific function, sleep quality, pain, health-related quality of life, and satisfaction with surgery. Assessments will be performed at predefined time points during the preoperative and postoperative follow-up period. The study is designed to provide an integrated assessment of recovery by combining objective wearable sensor-derived measures with standardized clinical assessments and patient-reported outcomes.
After completion of the 12-month follow-up, the data will be analysed by the study statistician. Baseline characteristics and outcome measures will be summarized descriptively. The primary analysis will evaluate the change in Oxford Knee Score (OKS) from baseline to 12 months in the whole cohort. As a secondary analysis, the change in OKS will be compared between the UKA and TKA groups.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Primary knee osteoarthritis: medial or lateral Kellgren Lawrence grade 3-4 for TKA and antero-medial grade 3-4 for UKA.
- •Patient criteria for outpatient knee arthroplasty (UKA or TKA):
- •Full overnight support by an adult at home after discharge
- •At most mild, well-controlled, comorbidities (e.g. hypertension, hypothyroidism, epilepsy, asthma)
- •ASA-class 1-2
- •Age <80 years
- •BMI <35 kg/m2
排除标准
- •Post-traumatic osteoarthritis
- •Neurological disorder aVecting walking or muscle strength
- •Inability or unwillingness to use a smartphone or to participate in the study
- •Exclusion criteria for outpatient surgery:
- •History of cardiac or cerebrovascular events
- •Conditions affecting consciousness (e.g. syncope of cardiac origin)
- •Untreated or central sleep apnoea
- •Heart failure
- •Diabetes mellitus type 1
- •Cognitive impairment or dementia
- •History of substance abuse
- •Chronic strong opioid therapy or severe pain disorder
- •Antithrombotic therapy (e.g. Xarelto, Pradaxa, Plavix or ASA for secondary prevention)
- •History of venous thromboembolism or known coagulopathy
研究组 & 干预措施
Medial unicompartmental knee arthroplasty (UKA)
Patients undergoing primary same-day discharge medial unicompartmental knee arthroplasty (UKA) for knee osteoarthritis. The medial UKA group will include 30 participants. The surgical procedure is determined by the treating clinical team according to established clinical indications and is not assigned by the study.
干预措施: Medial unicompartmental knee arthroplasty (UKA) (Procedure)
Total Knee Arthroplasty (TKA)
Patients undergoing primary same-day discharge total knee arthroplasty (TKA) for knee osteoarthritis. The TKA group will include 90 participants. The surgical procedure is determined by the treating clinical team according to established clinical indications and is not assigned by the study.
干预措施: Total knee arthroplasty (TKA) (Procedure)
结局指标
主要结局
Oxford Knee Score (OKS)
时间窗: The OKS will be completed by participants at baseline before surgery and at 3 and 12 months after surgery. The primary outcome is the change in OKS from baseline to 12 months after surgery.
A 12-item patient-reported questionnaire assessing knee pain and function during daily activities. Each item is scored from 0 to 4, giving a total score ranging from 0 to 48. Higher scores indicate better knee function and less pain.
次要结局
- Objectively measured physical activity (sensor)(Measurements will be performed during a two-week period before surgery, continuously from surgery to 3 months postoperatively, and during a further two-week period at 12 months after surgery.)
- Objectively measured sleep (sensor)(Measurements will be performed during a two-week period before surgery, continuously from surgery to 3 months postoperatively, and during a further two-week period at 12 months after surgery.)
- Isometric knee extension and flexion strength(Measurements will be performed before surgery and at 12 months after surgery.)
- Knee range of motion(Measurements will be performed before surgery and at 12 months after surgery.)
- Jenkins Sleep Scale (JSS)(The JSS will be completed at 2 weeks preoperatively and 12 months postoperatively.)
- Pain -visual analogue scale (VAS)(Measurements will be performed before surgery, 3 and 12 months after surgery.)
- Health-related quality of life(The questionnaire will be completed preoperatively, 3 and 12 months postoperatively.)
- Patient satisfaction(Satisfaction will be assessed at 3 and 12 months postoperatively.)
研究者
Juuso Hannula
PhD student
Turku University Hospital