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Accelerometry and Rehabilitation After Knee Replacement Study (ARK)

Study acronym: ARK
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Phase: Not specified to Not applicablev2 Show 8 more changesShow less
    • Primary and study completion dates: Dec 1, 2023 to Sep 1, 2026
    • Start date: Jan 1, 2022 to May 20, 2022
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Interventions: Remote monitoring of home-based exercises following knee replacement using a wearable sensor (Other), Standard Care (in control arm) (Other)
    • Secondary endpoints expanded, about 28 words
    • Site details revised
    • Study arms: 1 to 2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05412940
Lead Sponsor The Leeds Teaching Hospitals NHS Trust
Conditions
(from sponsor)
Orthopedic Disorder
Related terms Musculoskeletal Diseases
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov