Telemedicine in Total Knee Arthroplasty Using Wearable Technology
Completed
Conditions studied: Knee Arthritis
In brief
Subjectivity, cost-effectiveness, and inconsistent reporting limit monitoring after total knee arthroplasty (TKA). This prospective study leverages machine learning wearable technology to remotely monitor patients before and after TKA with fidelity and reliability, without sacrificing safe triage needing increased perioperative attention. Patients will download a mobile app that pairs with a "smart" knee sleeve to (1) monitor activity via daily step count, (2) solicit patient-reported outcomes, (3) calculate max flexion, and (4) provide physical therapy compliance data. The primary objective of this study is to determine validity and acceptability of the technology; secondary objectives include perioperative benchmarking with characterization of post-operative recovery trajectories.
Key facts
- Study ID
- NCT03406455
- Run by
- The Cleveland Clinic
- People needed
- 25
- Starts
- 2018-07-02
- Expected to finish
- 2019-05-15
- Last updated by the study team
- 2019-07-24
Who can join
Age: 60 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- patients undergoing primary TKA for osteoarthritis
- patients who have an iOS smartphone and carry it with them daily
- patients who reside in a home and not a facility or rehabilitation center
- patients under the age of 80 years
- patients who preoperatively have not used any assist devices for more than a year due to the non-affected joint or other functional reasons, including back pain.
You may not qualify if…
- patients receiving treatment for inflammatory arthritis
- patients receiving active or maintenance treatment for cancer or solid organ and/or marrow transplant
- patients with any other medical issues limiting mobility and function, including cardiopulmonary, gastrointestinal, and hematologic comorbidities
- patients indicated for TKA for post-traumatic or inflammatory arthritis
- patients who have ever had a periprosthetic joint infection of any joint
- patients who have a history of native septic arthritis in the operative joint
- patients who were functionally immobilized or residing anywhere other than a home (nursing facility, rehabilitation centers)
- patients who preoperatively used an assist device for more than a year (i.e. cane, walker)
- patients over the age of 80 years.
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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