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Physical Activity Levels During Recovery Following Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240769
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
The goal of this study is to utilize physical activity monitoring to determine the trajectory of normal recovery as it relates to a patient's ability to get up and get moving. From this work, we hope to be able to define the range in patients' physical activity following knee replacement surgery, and thus, give clinicians a tool and the methodology to identify patients whose recovery is not progressing as quickly as expected. Data from physical activity monitors will allow the research team to identify how active patients are, how vigorous that activity is, and how well that activity correlates with standard and commonly used patient questionnaires.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Knee Device: Total or Partial Knee Arthroplasty

Detailed Description:

This study is an observational study of the physical activity levels of adults who have been diagnosed with end-stage osteoarthritis of the knee and are undergoing knee replacement surgery at the Nuffield Orthopaedic Centre, Oxford. Data regarding patient activity and functional recovery will be collected using two methods. First, data will be collected through the extraction of three-axis accelerometer data, collected via a wrist-worn (and hip-worn for a subset of patients) physical activity monitor. This data will be collected in three intervals: pre-operatively, immediately postoperatively, and at 6 months postoperatively. Secondly, data will be collected by standard clinical assessment and patient reported outcome measures. These assessments will again take place pre-operatively, at 6 weeks postoperatively, and at 6 months postoperatively. Additional data will be collected through a simple activity diary, which asks the participants to log their monitor wear-time along with the times that they took bicycle rides or extended walks.

The expected duration of patient involvement is up to a total of 8 to 8.5 weeks over the course of up to 7 months. There are no clinical visits within this protocol beyond what is already within normal patient care. Patients will be asked to post their monitor back to the research centre for data collection and data processing twice during the study period.

The aim of this study is to assess the trajectory of recovery in terms of physical activity in the post-operative knee replacement population, and subsequently to define the expected path of early recovery.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying the Trajectory of Normal Recovery Following Knee Arthroplasty Through Physical Activity Monitoring Via Wrist-Worn Accelerometry
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Knee Arthroplasty Patient
Patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
Device: Total or Partial Knee Arthroplasty
Reconstruction of part or all of the native articulation at the knee joint via implant.
Other Name: Knee Replacement




Primary Outcome Measures :
  1. Change in physical activity [ Time Frame: Physical activity will be evaluated for 7 days at approximately 2 weeks before surgery, for 6 continuous weeks immediately postoperatively and (for a subset of participants) for 7 continuous days at 6 months postoperatively. ]
    The primary outcome measure will physical activity, as extracted from analysis of raw accelerometer data from the activity monitor. Several variables will be extracted from the raw data, including average acceleration vector (Euclidean norm minus one), bouts of physical activity and percentage of active and sedentary time.


Secondary Outcome Measures :
  1. Change in Oxford Knee Score [ Time Frame: Pre-operative (baseline), 6 weeks, 6 months ]
    A patient reported outcome measure (PROM) to assess patient benefit

  2. Change in EQ-5D-5L [ Time Frame: Pre-operative (baseline), 6 weeks, 6 months ]
    A PROM to assess patient benefit

  3. Change in University of California, Los Angeles (UCLA) Activity Score [ Time Frame: Pre-operative (baseline), 6 weeks, 6 months ]
    A PROM to assess patient benefit and physical activity

  4. Change in International Physical Activity Questionnaire - Short Form [ Time Frame: Pre-operative (baseline), 6 weeks, 6 months ]
    A PROM to assess patient benefit and physical activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Diagnosed with required late stage osteoarthritis, undergoing knee arthroplasty in the next 3 months.
  • In Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Participants who are enrolled in another research study involving an investigational product or methodology that could alter physical activity.
  • Participants are undergoing a revision arthroplasty surgery on the operative knee

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240769


Contacts
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Contact: Andrew J Price, DPhil, FRCS +44 01865 223421 andrew.price@ndorms.ox.ac.uk
Contact: Scott R Small, MS +44 01865 223414 scott.small@ndorms.ox.ac.uk

Locations
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United Kingdom
Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
Oxford, Oxfordshire, United Kingdom, OX3 7LD
Contact: Gail Lang       gail.lang@ndorms.ox.ac.uk   
Principal Investigator: Andrew J Price, DPhil, FRCS         
Sub-Investigator: Scott R Small, MS         
Sub-Investigator: Karen L Barker, PhD, FCSP         
Sub-Investigator: Sara Khalid, DPhil         
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Scott R Small, MS University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04240769    
Other Study ID Numbers: IRAS 260855
19/SW/0151 ( Other Identifier: NHS Health Research Authority )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be made available within 6 months following study completion.
Access Criteria: Data access requests will be reviewed by the trial steering committee.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
physical activity
rehabilitation
accelerometry