N/A
N=10
Home Monitoring After Primary Total Knee Arthroplasty
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT03032068 ↗Enrolled (actual)
10
Serious AEs
7.1%
Results posted
Jan 2022
Primary outcome: Primary: Overall Reliability of Monitoring Technology, Measured as Proportion of Actual Data Received From the Patient's Home Compared to the Amount of Data Expected (Based on Activities That Were Reported as Completed by Patients) Over the 12 Week Study Period. — 91 percentage of received vs expected data
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- At-Home Monitoring (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Reliability of Monitoring Technology, Measured as Proportion of Actual Data Received From the Patient's Home Compared to the Amount of Data Expected (Based on Activities That Were Reported as Completed by Patients) Over the 12 Week Study Period. |
91 | — |
| SECONDARY Rehab Compliance |
88; 94; 94 | — |
| SECONDARY Change From Preoperative to Postoperative Knee Range of Motion |
17; 5.8; 9.7; 2.2; -1.1; 13.3 | — |
| SECONDARY Change From Preoperative to Postoperative Timed Up and Go Test |
0.1; 0.1; 0.3; 0.0; -0.3; 0.6 | — |
| SECONDARY Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period) |
4; 4; 4; 4; 4; 2 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain |
41.7; 41.2; 54.6; 70.0; 68.5; 73.7 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form) |
41.1; 36.3; 56.0; 62.8; 73.0; 72.6 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL |
25.1; 25.0; 36.1; 43.8; 50.0; 52.1 | — |
Summary
Home monitoring technologies have recently emerged in many different areas of healthcare. These technologies are being used to provide rehabilitation to patients, and to prevent, identify, and manage complications. The investigators are proposing a method to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty (TKA) using an electronic home-based patient monitoring system with unique connectivity capabilities and prescriptive controls. The investigators will prospectively, electronically capture range of motion and gait parameters at specified intervals using Bluetooth sensors worn by the patient. The unique in-home patient monitoring platform will be utilized by 10 TKA patients once they return home following surgery. The investigators hypothesize that the use of an internet based home patient monitoring technology platform will reliably provide information related to the patients' pain and function and enhance patient feedback and communication after TKA. The hypothesis will be tested with the following aim: 1) To test the reliability of all technology utilized within the patient's home including but not limited to the sensors, the communication controller, the patient interface (Android tablet) and the internet by prospectively comparing between data collected through the home monitoring technology and traditional clinical measurements taken during physical therapy and surgical follow-up visits.
Eligibility Criteria
Inclusion Criteria
- Unilateral primary TKA
- Surgery is performed at Cleveland Clinic Main Campus or at Lutheran Hospital
- Patient must reside within 75 miles (driving distance) from Cleveland Clinic Main Campus
- Patient expected to utilize Cleveland Clinic Home Care Services after surgery
Exclusion Criteria
- Revision or simultaneous bilateral TKA
- English is not the patient's preferred language for healthcare discussions
- Currently participating in any other research study
Data sourced from ClinicalTrials.gov (NCT03032068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.