Investigating the Potential of Wearable Sensors for Monitoring the Postoperative Recovery of Total Knee Arthroplasty Patients: A Protocol for Prospective Longitudinal Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The postoperative changes from the baseline (preoperative) Fourier coefficients of walking acceleration signals at 12 months after total knee arthroplasty
研究概览
简要总结
The goal of this observational study is to investigate the potential of wearable sensors for monitoring the postoperative recovery of patients after TKA.
The main question the study aims to answer is:
• whether alterations in gait characteristics and the changes in PA levels measured by wearable PA trackers can accurately reflect a patient's postoperative recovery status and provide clinically relevant information to aid their management.
Participants will wear PA trackers during the perioperative period of TKA (2 weeks before until 3 months after, and then agin for 2 weeks one year after the surgery) and we will analyze their gait and PA and correlate them with their recovery after surgery.
详细描述
Introduction
Total knee arthroplasty (TKA) is a common surgical intervention for end-stage knee osteoarthritis (OA) patients who have failed conservative treatments. However, despite advances in surgical techniques and postoperative care, some patients experience complications and delayed recovery, leading to increased healthcare costs and worse clinical outcomes. Therefore, monitoring the postoperative recovery of TKA patients is critical for improving the outcomes and reducing healthcare costs.
Currently, various approaches assess patients' postoperative progress following TKA, including patient- and clinician-reported outcomes, as well as radiographic imaging. However, these methods are typically conducted at limited time intervals, and their objectivity is frequently questioned due to the potential for variability. The physical activity (PA) of patients, particularly walking as the primary form of PA, has proven to be a reliable indicator of their overall health and functionality. Abnormalities in walking patterns or reduced levels of physical activity can indicate decreased compliance, pain, or the occurrence of adverse events. Early diagnosis and treatment are crucial in mitigating the potential consequences of these adverse events, such as pulmonary embolism (PE), deep vein thrombosis (DVT), infection, and others.
In recent years, wearable sensors, such as PA trackers, have emerged as a promising tool for monitoring postoperative recovery. These sensors can continuously and objectively monitor a patient's PA levels and provide data that can be used to track the patients' recovery progress based on their daily activities. Furthermore, studies have demonstrated that patients are able to comply with the use of wearable sensors during the postoperative period after orthopedic surgeries. The investigators have demonstrated the patients' compliance with using the same sensors in a separate study. However, despite the potential benefits of wearable sensors for monitoring TKA recovery, several uncertainties remain. One key issue is whether changes in PA levels and gait alterations detected by wearable sensors can provide a reliable indicator of a patient's postoperative recovery status. Moreover, it is currently unclear whether the data collected from these sensors can yield clinically meaningful information that can effectively aid in managing TKA patients. Further research is needed to address these questions and establish the potential value of wearable sensors in the context of monitoring recovery after TKA.
Therefore, this study aims to investigate the potential of wearable sensors, specifically PA trackers, for monitoring the postoperative recovery of patients after TKA. Our study will recruit patients with knee OA scheduled to undergo TKA and monitor them continuously for three months after surgery using PA trackers. By analyzing the data collected from these trackers, the investigators aim to determine whether alterations in gait characteristics and the changes in PA levels measured by wearable PA trackers can accurately reflect a patient's postoperative recovery status and provide clinically relevant information to aid their management. In addition, in the study the investigators will measure PA and gait accelerations one year after TKA to evaluate the final outcome of the surgery once the recovery period is complete.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with knee OA and scheduled to undergo unilateral TKA at Aalborg University Hospital, Farsø.
排除标准
- •Daily pain (numeric rating scale (NRS) ≥ 4) or severe OA in the contralateral knee (KL-IV)
- •Daily pain (NRS ≥ 4) or severe OA in the spine and other lower limb joints
- •BMI > 35 kg/m2
- •Recent surgery in the spine or lower limbs (< 6 months)
- •Neurological movement disorders
- •Inflammatory arthritis
- •Patients who are not smartphone users
- •Frail patients with clinical frailty scale (CFS)10 ≥ 5
- •Residents of nursing homes
- •Patients dependent to walking aids for ambulation
- •Patients with dementia or memory problems
- •Patients with skin sensitivity or issues at the location of the plasters.
结局指标
主要结局
The postoperative changes from the baseline (preoperative) Fourier coefficients of walking acceleration signals at 12 months after total knee arthroplasty
时间窗: Two weeks before and 12 months after the surgery
3D lower limb accelerations corresponding to walking bouts will be extracted and transformed by Fast Fourier Transform. The first five pairs of Fourier coefficients will be used for data analysis.
The postoperative daily changes from the baseline (preoperative) Fourier coefficients of walking acceleration signals until 3 months after total knee arthroplasty
时间窗: Two weeks before the surgery until three months after the surgery
3D lower limb accelerations corresponding to walking bouts will be extracted and transformed by Fast Fourier Transform. The first five pairs of Fourier coefficients will be used for data analysis.
次要结局
- The postoperative daily changes from the baseline (preoperative) stance time until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative daily changes from the baseline (preoperative) sit-to-stand counts until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative daily changes from the baseline (preoperative) rest time until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative daily changes from the baseline (preoperative) step counts until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative changes from the baseline (preoperative) stance time at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The postoperative changes from the baseline (preoperative) rest time at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The postoperative changes from the baseline (preoperative) activity count index at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The postoperative daily changes from the baseline (preoperative) standing time until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative daily changes from the baseline (preoperative) activity count index until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative changes from the baseline (preoperative) standing time at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The postoperative daily changes from the baseline (preoperative) cadence until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative daily changes from the baseline (preoperative) sitting time until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative daily changes from the baseline (preoperative) walking time until 3 months after total knee arthroplasty(Two weeks before the surgery until three months after the surgery)
- The postoperative changes from the baseline (preoperative) cadence at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The postoperative changes from the baseline (preoperative) sitting time at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The change in EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire(Baseline (2 weeks before surgery); and 1 month, 2 months, 3 months, and 12 months after the surgery.)
- The postoperative changes from the baseline (preoperative) walking time at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The postoperative changes from the baseline (preoperative) step counts at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The postoperative changes from the baseline (preoperative) sit-to-stand counts at 12 months after total knee arthroplasty(Two weeks before and 12 months after the surgery)
- The change in Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline (2 weeks before surgery); and 1 month, 2 months, 3 months, and 12 months after the surgery.)
研究者
Ole Rahbek
Professor
Aalborg University Hospital