NCT03651739

Knee Connect: Measuring Range of Motion and Gait Metrics After Total Knee Arthroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The main goals of total knee replacement (TKR) surgery are to relieve pain and to allow patients to remain active. Sunnybrook is working with Kineris Inc.to advance a wearable device, the Knee Connect, aimed at tracking the physical recovery of patients after total knee replacements. After surgery, patients experience a gradual progression in function as their knee range of motion (ROM) increases and their gait patterns normalize. Goals for these metrics are well documented after the patient is fully recovered. However, there is a lack of detailed information available about the week by week improvements patients make in these metrics. The main objective of this study is to determine the accuracy of the Knee Connect device in quantifying the weekly improvements in ROM and gait parameters of patients recovering from surgery.

Detailed description

A research assistant will conduct in person data collections on 36 patients using the Kineris wearable device. The device is an electronic goniometer connected to a smart phone application. Patients will be recruited from the "Patient Orientation Program" (POP) at the Sunnybrook Holland Centre. Data collection will occur preoperatively, at the end of each physiotherapy Knee Class session, and at the three month postoperative clinic visit. The research assistant will help fit and attach the wearable device to each patient's knee. Patients will be asked to bend their knee (flexion and extension) while wearing the device which will measure patients range of motion. The research assistant will also measure knee range of motion using a handheld protractor. Afterward, patients will be asked to walk 10 steps, using any walking aids or techniques they typically use at home. There will be 15 collections per patient requiring ten minutes per session. Chart reviews will also be conducted to determine patient reported outcomes which will be then correlated with the functional measures. All data will be extracted and input into an excel file. For both the ROM tests, the accuracy of the Knee Connect device will be compared against the plastic goniometer. This will be done by using a paired t-test and calculating interclass correlation coefficient. The data will then be analyzed using a repeated measures ANOVA and Bonferroni post-hoc analysis to determine differences in the variables week to week. Additionally, a regression analysis will be used to estimate the week by week improvements in these variables.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	Knee Connect	An electronic goniometer with smart phone application

Timeline

• Start date: 2018-10-02
• Primary completion: 2019-12-11
• Completion: 2019-12-11
• First posted: 2018-08-29
• Last updated: 2020-08-18

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study