Knee Replacement Clinical Trials

Clinical trials related to Knee Replacement Procedure

Empowering Knee Recovery After Total Knee Replacement Through Digital Health (Knee4life Project)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• People aged ≥18 years old

• Recently had a total knee replacement surgery or has worked with people following this surgery as a clinical, carer or therapist

• Able to give informed consent

• Able to communicate in English with the research team

Locations
Other Locations
United Kingdom
University of Exeter
RECRUITING
Exeter
Contact Information
Primary
Maedeh Mansoubi, PhD
M.Mansoubi@exeter.ac.uk
07866138722
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-05
Participants
Target number of participants: 75
Treatments
Healthy Controls (lab assessment)
Participants will be asked to complete 8 questionnaires before the lab assessments: The data will be entered and saved onto REDCap by a member of the research team. The 8 questionnaires including baseline data are PROMIS-29 v2, Oxford Knee Score, IPAQ Short Last 7 Days, Numeric Rating Scale, Single Ease Question, Barthel Index for Activities of Daily Living and EQ-5D-5L.~Participants will be asked to complete the following:~2-minute walk on a treadmill 10 m walk (5 m x 2). Timed up and Go (TUG) Sit to stand test~At home:~TUG Sit to stand test
Participant post total knee replacement surgery (lab assessment)
Participants will be asked to complete 8 questionnaires before the lab assessments: The data will be entered and saved onto REDCap by a member of the research team. The 8 questionnaires including baseline data are PROMIS-29 v2, Oxford Knee Score, IPAQ Short Last 7 Days, Numeric Rating Scale, Single Ease Question, Barthel Index for Activities of Daily Living and EQ-5D-5L.~Participants will be asked to complete the following:~2-minute walk on a treadmill 10 m walk (5 m x 2). Timed up and Go (TUG) Sit to stand test~At home:~TUG Sit to stand test
Healthcare professionals (focus group)
A member of the research team will conduct interviews to discuss how the knee4life project and how final tool can be deployed in clinics and services. These discussions will provide valuable insights into the future adoption and application of computer-vision technology. These will take place online.
Stakeholders (focus group)
A member of the research team will conduct interviews to discuss how the knee4life project and how final tool can be deployed in clinics and services. These discussions will provide valuable insights into the future adoption and application of computer-vision technology. These will take place online.
Participants post total knee replacement surgery
A member of the research team will conduct interviews to discuss how the knee4life project and how final tool can be deployed in clinics and services. These discussions will provide valuable insights into the future adoption and application of computer-vision technology. These will take place online.
Related Therapeutic Areas
Sponsors
Leads: University of Exeter
Collaborators: Exeter Biomedical Research Centre (BRC) grant, National Institute for Health Research, United Kingdom

This content was sourced from clinicaltrials.gov