Accelerometry and Rehabilitation After Knee Replacement Study (ARK) (ARK)

Accelerometry and Rehabilitation After Knee Replacement Study (ARK): A Prospective, Randomised Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Disorder

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Recruiting
      • Leeds Teaching Hospitals NHS Trust
      • Contact: Jaya Palan; Phone Number: 0113 2433144; Email: jeya.palan@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Operating lists will be screened by the clinical trials team to identify eligible patients and patient information sheets will be sent out with invitation to meet surgeon and confirm eligibility.
2. Potentially eligible patients will be provided with a patient information sheet at their routine pre-operative outpatient clinic and their eligibility confirmed by their operating surgeon

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Primary total knee replacement patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Oxford Knee Score (OKS) at 6 months from surgery	Completion of Patient satisfaction at 6 months after surgery using a survey questionnaire.	6 months

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: OR21/144310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No