Orthopedic Disorder
Conditions
Brief summary
Total knee replacement (TKR) is a successful and cost-effective treatment for end-stage arthritis. Its usage is increasing due to changing population demographics and quality of life (QoL) expectations. There were almost 100,000 total knee replacements (TKR) performed in England between 2018/19. After TKR, patient engagement in their rehabilitation exercises is very important but physiotherapy services are very stretched at present especially in the covid-19 era. Patient compliance with their exercises is poor at about 25%. The use of wearable sensors (WS) following TKR is gaining lots of interest especially in the post covid-era. A recent review found five small studies which supported the feasibility of their use. WS may help with patients to engage better with their rehabilitation exercises after surgery, delivering remote physiotherapy and potentially help identify patients who may be struggling more and therefore need further targeted help with physiotherapy. Sensors have the potential to be a cost-saving intervention for the NHS by improving efficiencies in monitoring patients by reducing number of outpatient appointments, reducing rehabilitation time, improving patient's adherence to rehabilitation schedules and increasing confidence in exercise regimes leading to improved health-related quality of life. We will conduct the first large scale study where 250 patients having TKR will be randomly chosen to either receive a WS (125 patients) against 125 patients who will have standard care (SC). Patient reported outcomes (PROMs), pain scores, objective measures of knee function and data from the sensors on how well patients engaged with their exercises will be collected. The study will also assess if WS is cost effective, at 6 months after surgery. This study has the potential to revolutionise how pre- and post-knee replacement rehabilitation is delivered, providing an individualised, cost effective and successful solution to the current status.
Interventions
OTHERRemote monitoring of home-based exercises following knee replacement using a wearable sensor
Remote monitoring of home-based exercises following knee replacement using a wearable sensor
OTHERStandard Care (in control arm)
Unsupervised home-based exercises following knee replacement
Sponsors
The Leeds Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Primary total knee replacement patients * Participant is aged 18 years of age or over * Participant is able and willing to provide written informed consent * Participant with ability to work with smart devices * Participant having own device (Apple iPhone or iPad or Android tablet or smartphone - minimum requirement: IOS - 12.4 or later/Android - 6.5 or later) * Internet connection at patient's home - either Wifi or mobile internet (min. 3G)
Exclusion criteria
* • Participants who are unwilling or mentally and/or physically unable to adhere to study procedures * Participants with dementia or other cognitive impairment which would prevent them from using the sensor/app * Presence of a previous joint replacement in the same knee * Surgical treatment of involved knee within the past 6 months (excluding arthroscopy) * Previous orthopaedic surgery for trauma or arthritis of the knee joint (such as a previous fracture fixation or osteotomy) * Active cancer (currently diagnosed and under treatment) * Unable to complete all trial procedures (e.g. attend follow up visits, complete questionnaires) * Unable to provide informed consent (cognitive disorder such as dementia, psychiatric illness)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score (OKS) | Completion of Patient satisfaction at 6 months (primary outcome), in addition to baseline, pre-operative, 6 weeks, 12 months after surgery | The Oxford Knee Score (OKS) is a 12-item, patient-reported outcome measure designed to assess pain and physical function in patients undergoing total knee replacement, with total scores ranging from 0 to 48, where higher scores represent better joint function and minimal pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury & Osteoarthritis Outcomes Score (KOOS) | Baseline, 6 weeks, 6 months | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item, patient-reported instrument assessing short- and long-term knee injury outcomes across five subscales: Pain, Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function, and Knee-Related Quality of Life (each scored 0-100, where 100 indicates no knee problems). |
| Self-Administered Patient Satisfaction (SAPS) | 6 weeks, 6 months | The Self-Administered Patient Satisfaction (SAPS) scale is a 4-item, patient-reported instrument designed to measure overall satisfaction following orthopedic surgery, evaluating satisfaction with current symptoms, pain relief, ability to perform home/yard work, and ability to perform recreational activities, with scores ranging from 0 to 100 where higher scores indicate greater satisfaction. |
| EQ-5D-5L | Baseline, 6 weeks, 6 months, 12 months | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a standardized, patient-reported instrument measuring health-related quality of life across five dimensions-Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression-each rated on 5 levels of severity, alongside a Visual Analogue Scale (EQ-VAS) measuring overall health from 0 to 100 (where 100 indicates the best imaginable health). |
| Wong-Baker FACES Pain Rating Scale (WB-FPRS) | Baseline, 6 weeks, 6 months | The Wong-Baker FACES Pain Rating Scale (WB-FPRS) is a patient-reported visual instrument that measures pain intensity using six drawn faces depicting progressive levels of distress, scored from 0 (no hurt) to 10 (hurts worst) in increments of two, where higher scores indicate greater pain severity. |
| Goniometric range of motion (ROM) | Baseline, 6 weeks, 6 months | Goniometric range of motion (ROM) is an objective physical assessment measuring active and passive joint mobility in degrees using a standard goniometer, evaluating joint flexion and extension where higher degrees indicate greater range of motion. |
| Timed Up and Go (TUG) | Baseline, pre-operative, 6 weeks, 6 months | The Timed Up and Go (TUG) test is an objective functional mobility and balance assessment that measures the time (in seconds) required for a participant to rise from a standard armchair, walk 3 meters, turn, walk back, and sit down, where shorter times indicate better functional mobility and physical performance. |
Countries
United Kingdom
Outcome results
None listed