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

NCT03651739 | Completed FDA Device

• 1 other identifier: 02KINERIS2017
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Knee range of motion

  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

  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

  One pre-operative, one during inpatient stay, 12 during knee class visits, one during 3 month clinic visit

• Swing Range of Motion

  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

  One at 6 week visit, one during 3 month clinic visit

Study Arms (1)

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

Interventions

Knee Connect DEVICE

An electronic goniometer with smart phone application

TKR Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Revision total knee arthroplasty
• Neuromuscular disorder
• Bilateral TKR procedures

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

Location

Related Publications (7)

• 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.

  PMID: 28241434 BACKGROUND

• 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.

  PMID: 9802659 BACKGROUND

• 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.

  PMID: 2910598 BACKGROUND

• 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.

  PMID: 7458617 BACKGROUND

• 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.

  PMID: 8792240 BACKGROUND

• 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.

  PMID: 24743160 BACKGROUND

• 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.

  PMID: 20851566 BACKGROUND

Study Officials

• David Wasserstein, MD

  Sunnybrook Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 29, 2018
• Study Start: October 2, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

CA (1)