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Accelerometry and Rehabilitation After Knee Replacement Study (ARK)

Sponsor
The Leeds Teaching Hospitals NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05412940
Collaborator
(none)
250
Enrollment
1
Location
23
Anticipated Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Accelerometry and Rehabilitation After Knee Replacement Study (ARK): A Prospective, Randomised Controlled Trial.
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Primary total knee replacement patients

    Outcome Measures

    Primary Outcome Measures

    1. Completion of Oxford Knee Score (OKS) at 6 months from surgery [6 months]

      Completion of Patient satisfaction at 6 months after surgery using a survey questionnaire.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leeds Teaching Hospitals NHS Trust Leeds West Yorkshire United Kingdom LS9 7TF

    Sponsors and Collaborators

    • The Leeds Teaching Hospitals NHS Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Leeds Teaching Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT05412940
    Other Study ID Numbers:
    • OR21/144310
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Musculoskeletal Diseases

    Study Results

    No Results Posted as of Jun 9, 2022