Telemedicine in Total Knee Arthroplasty Using Wearable Technology

Knee Arthritis Clinical Trial

Official title:

Telemedicine in Total Knee Arthroplasty Using Wearable Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406455
• Other study ID #: ClevelandCF02
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: July 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthritis

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ramkumar PN, Harris JD, Noble PC. Patient-reported outcome measures after total knee arthroplasty: a systematic review. Bone Joint Res. 2015 Jul;4(7):120-7. doi: 10.1302/2046-3758.47.2000380. Review. — View Citation

Ramkumar PN, Muschler GF, Spindler KP, Harris JD, McCulloch PC, Mont MA. Open mHealth Architecture: A Primer for Tomorrow's Orthopedic Surgeon and Introduction to Its Use in Lower Extremity Arthroplasty. J Arthroplasty. 2017 Apr;32(4):1058-1062. doi: 10.1016/j.arth.2016.11.019. Epub 2016 Nov 17. — View Citation

Ramkumar PN, Navarro SM, Chughtai M, La T Jr, Fisch E, Mont MA. The Patient Experience: An Analysis of Orthopedic Surgeon Quality on Physician-Rating Sites. J Arthroplasty. 2017 Sep;32(9):2905-2910. doi: 10.1016/j.arth.2017.03.053. Epub 2017 Apr 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Semi-structured interviewed	3 months postoperative
Secondary	Step Count in steps per day	Passively collect steps for TKA patients before and after surgery. This will be used for comparing pre- and post-operative improvements.	Daily, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 120 days
Secondary	Maximum knee range of motion in degrees	Actively collect max extension and flexion for TKA patients before and after surgery. This will be used for comparing pre- and post-operative improvements.	Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Secondary	Patient Reported Outcome Measures (linear numeric scale from 0 to 28)	Actively collect KOOS Jr., VAS pain scales. This will be used for comparing pre- and post-operative improvements.	Weekly, from 4 weeks preoperatively to 3 months postoperatively totaling approximately 16 weeks
Secondary	Home Exercise Plan compliance	Passively collect completion of at least one home exercise per day, as reported in binary fashion (yes or no)	Daily, from day of surgery to 3 months postoperatively totaling approximately 90 days