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

• ClinicalTrials.gov Identifier: NCT03651739
• Recruitment Status: Completed
• First Posted: August 29, 2018
• Last Update Posted: August 18, 2020
• Sponsor: Sunnybrook Health Sciences Centre
• Information provided by (Responsible Party): Sunnybrook Health Sciences Centre

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Arthroplasty, Replacement, Knee	Device: Knee Connect

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Knee Connect: Measuring Range of Motion and Gait Metrics After Total Knee Arthroplasty
• Actual Study Start Date: October 2, 2018
• Actual Primary Completion Date: December 11, 2019
• Actual Study Completion Date: December 11, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
TKR Patients; Any patient undergoing total knee arthroplasty and will use the Knee Connect during their knee classes at the Holland Centre	Device: Knee Connect; An electronic goniometer with smart phone application

Outcome Measures

Primary Outcome Measures :

1. Knee Range of Motion Error [ Time Frame: 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 ]

   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.

Secondary Outcome Measures :

1. Knee range of motion [ Time Frame: 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 ]
   The weekly knee range of motion (in degrees) measured by the Knee Connect
2. Stride Time [ Time Frame: 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 ]
   The weekly gait stride time (in seconds) measured by the Knee Connect
3. Stance Range of Motion [ Time Frame: One pre-operative, one during inpatient stay, 12 during knee class visits, one during 3 month clinic visit ]
   The weekly gait stance range of motion (in degrees) measured by the Knee Connect
4. Swing Range of Motion [ Time Frame: 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 ]
   The weekly gait swing range of motion (in degrees) measured by the Knee Connect
5. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: One at 6 week visit, one during 3 month clinic visit ]

   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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Patient Orientation Program clinic, approximately 4-6 weeks pre-surgery. Patients must be available for testing at the end of every Knee Class therapy session, for the duration of their Knee Class visits.

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Sunnybrook Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, Canada, M4Y 1H1

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators

• Principal Investigator: David Wasserstein, MD; Sunnybrook Hospital

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT03651739
• Other Study ID Numbers: 02KINERIS2017
• First Posted: August 29, 2018
• Last Update Posted: August 18, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sunnybrook Health Sciences Centre:

Rehabilitation