- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03651739
Knee Connect: Measuring Range of Motion and Gait Metrics After Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M4Y 1H1
- Sunnybrook Holland Orthopaedic & Arthritic Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
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
|
An electronic goniometer with smart phone application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
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
|
One pre-operative, one during inpatient stay, 12 during knee class visits, one during 3 month clinic visit
|
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
|
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
|
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 |
One at 6 week visit, one during 3 month clinic visit
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Wasserstein, MD, Sunnybrook Hospital
Publications and helpful links
General 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):418. 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. doi: 10.1016/s0883-5403(98)90025-0.
- 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 (1978). 1980;97(4):309-17. doi: 10.1007/BF00380714.
- 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. doi: 10.1016/s0883-5403(96)80023-4.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 02KINERIS2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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