Status:
ACTIVE_NOT_RECRUITING
Knee Arthroplasty Activity Trial
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Northwestern Memorial Hospital
University of Kansas Medical Center
Conditions:
Knee Osteoarthritis
Total Knee Replacement
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
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 in...
Detailed Description
The investigators have designed the KArAT trial with two specific aims. First, to conduct a parallel three-arm RCT to establish the efficacy and sustainability of the effect of personalized interventi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04107649
Start Date
April 27 2023
End Date
June 15 2028
Last Update
November 24 2025
Active Locations (5)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198