Physical Activity Levels During Recovery Following Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT04240769|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment|
|Arthroplasty, Replacement, Knee||Device: Total or Partial Knee Arthroplasty|
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|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|
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
- 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.
- Change in Oxford Knee Score [ Time Frame: Pre-operative (baseline), 6 weeks, 6 months ]A patient reported outcome measure (PROM) to assess patient benefit
- Change in EQ-5D-5L [ Time Frame: Pre-operative (baseline), 6 weeks, 6 months ]A PROM to assess patient benefit
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240769
|Contact: Andrew J Price, DPhil, FRCS||+44 01865 email@example.com|
|Contact: Scott R Small, MS||+44 01865 firstname.lastname@example.org|
|Nuffield Orthopaedic Centre, Oxford University Hospitals Trust|
|Oxford, Oxfordshire, United Kingdom, OX3 7LD|
|Contact: Gail Lang email@example.com|
|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|
|Principal Investigator:||Scott R Small, MS||University of Oxford|