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

NCT ID: NCT03651739

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2019-12-11

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

TKR Patients

Any patient undergoing total knee arthroplasty and will use the Knee Connect during their knee classes at the Holland Centre

Knee Connect

Intervention Type: DEVICE

An electronic goniometer with smart phone application

Interventions

Knee Connect

An electronic goniometer with smart phone application

Intervention Type: DEVICE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wasserstein, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Hospital

Locations

Sunnybrook Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 28241434 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9802659 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2910598 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7458617 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8792240 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24743160 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20851566 (View on PubMed)

Other Identifiers

02KINERIS2017

Identifier Type: -

Identifier Source: org_study_id