Physical Activity Levels During Recovery Following Knee Arthroplasty

NCT04240769 | Unknown

• 2 other identifiers: IRAS 26085519/SW/0151
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

physical activity; rehabilitation; accelerometry

Outcome Measures

Primary Outcomes (1)

• Change in physical activity

  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.

  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.

Secondary Outcomes (4)

• Change in Oxford Knee Score

  Pre-operative (baseline), 6 weeks, 6 months

• Change in EQ-5D-5L

  Pre-operative (baseline), 6 weeks, 6 months

• Change in University of California, Los Angeles (UCLA) Activity Score

  Pre-operative (baseline), 6 weeks, 6 months

• Change in International Physical Activity Questionnaire Questionnaire - Short Form

  Pre-operative (baseline), 6 weeks, 6 months

Study Arms (1)

Knee Arthroplasty Patient

Patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.

Device: Total or Partial Knee Arthroplasty

Interventions

Total or Partial Knee Arthroplasty DEVICE

Reconstruction of part or all of the native articulation at the knee joint via implant.

Also known as: Knee Replacement

Knee Arthroplasty Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be patients undergoing primary total or unicompartmental knee arthroplasty for treatment of end-stage osteoarthritis.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Nuffield Orthopaedic Centre, Oxford University Hospitals Trust

Oxford, Oxfordshire, OX3 7LD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Scott R Small, MS

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew J Price, DPhil, FRCS

CONTACT

+44 01865 223421; andrew.price@ndorms.ox.ac.uk

Scott R Small, MS

CONTACT

+44 01865 223414; scott.small@ndorms.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: January 31, 2020
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

GB (1)