Knee Arthroplasty Activity Trial

Description

Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded $11 billion. Growing evidence suggests that while pain and functional status improve following TKR, physical activity (PA) typically does not surpass pre-TKR levels. Engagement in PA can meaningfully improve quality of life (QoL), pain, and function. Given the large investment in TKR, the effectiveness and cost-effectiveness of TKR could be substantially increased if TKR recipients became more physically active. The Knee Arthroplasty Activity Trial (KArAT) is a randomized controlled trial and participants will be randomly assigned to one of three arms. Participants across all arms will receive usual post-operative care for TKR surgery. Participants in the first arm will complete basic study activities, such as responding to surveys and attending two in-person clinic visits. Participants in the second arm will do the same and also receive a wrist-based physical activity tracker intervention. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (for reaching physical activity goals) (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will be eligible to receive lottery-based financial rewards for wearing a wrist-worn activity tracker for twenty-four months during the study.

Conditions

Knee Osteoarthritis, Total Knee Replacement

Study Overview

Study Details

Study overview

Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded $11 billion. Growing evidence suggests that while pain and functional status improve following TKR, physical activity (PA) typically does not surpass pre-TKR levels. Engagement in PA can meaningfully improve quality of life (QoL), pain, and function. Given the large investment in TKR, the effectiveness and cost-effectiveness of TKR could be substantially increased if TKR recipients became more physically active. The Knee Arthroplasty Activity Trial (KArAT) is a randomized controlled trial and participants will be randomly assigned to one of three arms. Participants across all arms will receive usual post-operative care for TKR surgery. Participants in the first arm will complete basic study activities, such as responding to surveys and attending two in-person clinic visits. Participants in the second arm will do the same and also receive a wrist-based physical activity tracker intervention. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (for reaching physical activity goals) (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will be eligible to receive lottery-based financial rewards for wearing a wrist-worn activity tracker for twenty-four months during the study.

Knee Arthroplasty Activity Trial

Knee Arthroplasty Activity Trial

Condition
Knee Osteoarthritis
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Buffalo

University at Buffalo, Buffalo, New York, United States, 14215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 40-85 years
  • * English-speaking
  • * Scheduled to undergo primary, unilateral total knee replacement (TKR) at one of the 4 recruitment centers
  • * OA is principal underlying indication for TKR
  • * During an accelerometer run-in period lasting one week at baseline (prior to surgery), subjects must show that they can comply with waist-worn physical activity tracker protocols by wearing the activity tracker for ≥4/7 days of the week for ≥10 hours/day
  • * Regular access to a personal computer, laptop, tablet, or smartphone for wrist-worn activity tracker syncing
  • * Satisfying average baseline steps/day criteria (calculated from waist-worn activity tracker data from the run-in period)
  • * Non-English speaking
  • * Residence in nursing home
  • * Diagnosis of dementia, epilepsy, Parkinson's Disease, or diabetes with peripheral neuropathy
  • * Inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, polymyalgia)
  • * Psychological issues that preclude participation
  • * Inpatient or other musculoskeletal surgery scheduled within six months following index primary TKR
  • * Uses a wheelchair to ambulate (subjects who use a cane will be eligible)
  • * Surgeon-documented other reason for study exclusion
  • * Subject does not have regular access to a device capable of receiving email or text messages

Ages Eligible for Study

40 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Elena Losina, Ph.D., PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2028-06-15