Knee4Life Project: Empowering Knee Recovery After Total Knee Replacement Through Digital Health

NCT06429462 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2024-05-28

No results posted yet for this study

Summary

The research project will investigate the extent to which a smartphone camera sensor tool can help predict and measure knee stiffness and pain after Total Knee Replacement Surgery (TKR) and how a tool such as this could be implemented into the NHS.

Total knee replacement (TKR) is a frequent procedure undertaken in England and Wales, with more than 100,000 conducted each year. Although most patients have a successful outcome following their TKR, approximately 10-20% of patients are dissatisfied, predominantly because of pain and knee stiffness. A method to detect early problems with pain and stiffness could facilitate earlier referral to non-surgical treatments, which are effective in preventing the need for manipulation under anaesthetic (MUA). Here the investigators will validate and provide proof of concept for a smartphone camera sensor tool that measures knee range of motion alongside symptoms of pain for use in the home setting.

The study will comprise of 3 stages;

1. We will conduct 45 minute online interviews comprising of (1) people who have had total knee replacement surgery, (2) healthcare professionals and stakeholders.
2. We will invite 30 participants who are 5-9 weeks post TKR and 30 participants who have had no previous musculoskeletal injuries to attend a session at the university. The lab testing will be conducted at the VSimulator, a biomechanics research lab at the Exeter Science park, and at the teaching labs on St Lukes Campus, Exeter. Here participants be asked to answer 8 questionnaires and have some of their movements measured.
3. Participants will be asked to repeat the 'timed up and go' and the 'sit to stand' tests in their homes and record them using a mobile device.

The study is funded by the NIHR Exeter Biomedical Research Centre grant and sponsored by the University of Exeter.

Conditions

  • Total Knee Replacement

Interventions

DIAGNOSTIC_TEST

smartphone camera sensor tool

The study will involve the development and validation of a computer vision-based approach (using cameras to assess movements) to monitor knee flexion and extension, and a walking pattern assessment.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV
  • Exeter Biomedical Research Centre (BRC) grant

    collaborator UNKNOWN
  • University of Exeter

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06429462 on ClinicalTrials.gov