Telemedicine in Total Knee Arthroplasty Using Wearable Technology



Status:Recruiting
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:60 - 80
Updated:7/20/2018
Start Date:July 2, 2018
End Date:September 1, 2019
Contact:Prem N Ramkumar, MD MBA
Email:premramkumar@gmail.com
Phone:5626196205

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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.

Monitoring of pre-operative status and post-operative recovery from elective orthopaedic
surgery is critical to delivering safe, value-based care. Measurement after TKA has
traditionally been accomplished through clinician in-office assessments, validated surveys,
or both; subjectivity, cost-effectiveness, and inconsistent reporting limit these
assessments. Leveraging now ubiquitous smartphone technology and smart wearable technology
with machine learning software offers the opportunity to remotely monitor patients before and
after surgery. This provides surgeons, hospitals, and stakeholders the opportunity to
objectively quantify (1) patient compliance, (2) value of a given surgical procedure with
unprecedented benchmarking, and, more importantly, (3) the better triage of those needing
increased perioperative attention. Regardless of the orthopaedic procedure, a motion-based
machine learning software application to commercial mobile and wearable technology readily
and inexpensively unlocks the potential of delivering value-based care through the low
maintenance acquisition of both precision, small data that may then be extrapolated to
population-level revelations from big data regardless of the joint or extremity. With the
rise of telemedicine, clinical validation of the technology is of mutual interest to
orthopaedic patients, surgeons, administrators, payers, and policymakers.

Inclusion Criteria:

1. patients undergoing primary TKA for osteoarthritis

2. patients who have an iOS smartphone and carry it with them daily

3. patients who reside in a home and not a facility or rehabilitation center

4. patients under the age of 80 years

5. 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.

Exclusion criteria:

1. patients receiving treatment for inflammatory arthritis

2. patients receiving active or maintenance treatment for cancer or solid organ and/or
marrow transplant

3. patients with any other medical issues limiting mobility and function, including
cardiopulmonary, gastrointestinal, and hematologic comorbidities

4. patients indicated for TKA for post-traumatic or inflammatory arthritis

5. patients who have ever had a periprosthetic joint infection of any joint

6. patients who have a history of native septic arthritis in the operative joint

7. patients who were functionally immobilized or residing anywhere other than a home
(nursing facility, rehabilitation centers)

8. patients who preoperatively used an assist device for more than a year (i.e. cane,
walker)

9. patients over the age of 80 years.
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 562-619-6205
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Cleveland, OH
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