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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651739
• Other study ID #: 02KINERIS2017
• Status: Completed
• Start date: October 2, 2018
• Est. completion date: December 11, 2019

Study information

• Verified date: August 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Be currently on the waiting list for a primary TKR

• Be enrolled for the "Knee Class" postoperative physiotherapy at the Sunnybrook Holland Centre with the expectation of attending the class through the duration of the class.

• Be able to provide informed consent.

Exclusion Criteria:

• Revision total knee arthroplasty

• Neuromuscular disorder

• Bilateral TKR procedures

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Knee Connect
An electronic goniometer with smart phone application

Locations

Country	Name	City	State
Canada	Sunnybrook Holland Orthopaedic & Arthritic Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Chao EY, Laughman RK, Stauffer RN. Biomechanical gait evaluation of pre and postoperative total knee replacement patients. Arch Orthop Trauma Surg. 1980;97(4):309-17. — View Citation

Chiang CY, Chen KH, Liu KC, Hsu SJ, Chan CT. Data Collection and Analysis Using Wearable Sensors for Monitoring Knee Range of Motion after Total Knee Arthroplasty. Sensors (Basel). 2017 Feb 22;17(2). pii: E418. doi: 10.3390/s17020418. — View Citation

Dennis DA, Komistek RD, Stiehl JB, Walker SA, Dennis KN. Range of motion after total knee arthroplasty: the effect of implant design and weight-bearing conditions. J Arthroplasty. 1998 Oct;13(7):748-52. — View Citation

Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20. — View Citation

Seel T, Raisch J, Schauer T. IMU-based joint angle measurement for gait analysis. Sensors (Basel). 2014 Apr 16;14(4):6891-909. doi: 10.3390/s140406891. — View Citation

Steiner ME, Simon SR, Pisciotta JC. Early changes in gait and maximum knee torque following knee arthroplasty. Clin Orthop Relat Res. 1989 Jan;(238):174-82. — View Citation

Wilson SA, McCann PD, Gotlin RS, Ramakrishnan HK, Wootten ME, Insall JN. Comprehensive gait analysis in posterior-stabilized knee arthroplasty. J Arthroplasty. 1996 Jun;11(4):359-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Range of Motion Error	The difference in measured knee range of motion (in degrees) between the Knee Connect and the handheld goniometer.; Completed at each study time point (listed below) in order to gather as much data on the accuracy of knee connect compared to the goniometer.	One reading 2-4 weeks pre-operation, two readings weekly for 2-6 weeks post-operation (during physiotherapy knee class visits), one during 3 month post-operative clinic visit
Secondary	Knee range of motion	The weekly knee range of motion (in degrees) measured by the Knee Connect	One reading 2-4 weeks pre-operation, two readings weekly for 2-6 weeks post-operation (during physiotherapy knee class visits), one during 3 month post-operative clinic visit
Secondary	Stride Time	The weekly gait stride time (in seconds) measured by the Knee Connect	One reading 2-4 weeks pre-operation, two readings weekly for 2-6 weeks post-operation (during physiotherapy knee class visits), one during 3 month post-operative clinic visit
Secondary	Stance Range of Motion	The weekly gait stance range of motion (in degrees) measured by the Knee Connect	One pre-operative, one during inpatient stay, 12 during knee class visits, one during 3 month clinic visit
Secondary	Swing Range of Motion	The weekly gait swing range of motion (in degrees) measured by the Knee Connect	One reading 2-4 weeks pre-operation, two readings weekly for 2-6 weeks post-operation (during physiotherapy knee class visits), one during 3 month post-operative clinic visit
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index	Western Ontario and McMaster Universities Osteoarthritis Index function sub-scale and total score; Sub scales: Pain (5 items, each rated on a scale from 0-4); Joint stiffness (2 items, each rated on a scale from 0-4), Physical function (17 items, each rated on a scale from 0-4 for level of difficulty); Score range: Pain subscale 0-20 WOMAC points; Joint stiffness subscale 0-8 WOMAC points. Physical function subscale 0-68 WOMAC points. Total score 0-96 WOMAC points (96 = worse pain, stiffness and physical function). Subscales are summed for total score	One at 6 week visit, one during 3 month clinic visit