Conventional vs. Sensor Guided Soft Tissue Balancing in TKA RCT

Randomized Controlled Trial of Sensor Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty

To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and proper implant position are very important during the surgical procedure. Soft tissues are structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning may result in knee stiffness, pain, instability and limited range of motion (ROM). This may result in implant failure and the need for revision surgery. As part of standard practice orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to achieve optimal knee balance. New sensor-assisted technology can provide surgeons with measurable information to help achieve soft tissue balancing, providing surgeons with immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the sensor, gives surgeons electronic information on soft tissue balance and implant position.The purpose of this study is to determine if a sensor guided soft tissue balancing device (Verasense) is more effective at balancing the knee during surgery as compared to standard soft tissue balancing performed with a manual balancer device.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Procedure: Standard Soft Tissue Balancing; Procedure: Sensor Guided Soft Tissue Balancing

Detailed Description

The study is that of a prospective double-blind randomized controlled trial of patients presenting for elective primary TKR to compare the outcomes of TKR using conventional soft tissue balancing with a tensiometer device versus augmenting the soft tissue balancing with the OrthoSensor VerasenseTM sensor device. The primary outcome will be rate of unbalanced TKRs based on the quantitative Verasense definition of a well balanced knee defined as a mediolateral intercompartmental loading difference of ≤15 pounds through ROM. Secondary outcomes include differences in clinical outcome scores and patient satisfaction among sensor guided cases and controls.

Patients will be randomized to receive TKR with the Triathlon total knee system (Stryker) in the case and control group according to: (1) control group with standard balancing techniques used and sensor data obtained in blinded fashion and not used to balance the TKR implant, (2) experimental case group with sensor guided balancing where sensor data is used to balance the TKR within defined parameters.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Hamilton Health Sciences Juravinski Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled to undergo elective primary unilateral TKR for a diagnosis of osteoarthritis to be performed at the study site by the primary investigators
• Willingness and ability to give informed consent.

Exclusion Criteria:

• Inflammatory arthropathy
• Ligament insufficiencies
• Contraindications to posterior cruciate retaining TKR including: deformity >15 degrees or fixed-flexion contracture >15 degrees
• Previous high tibial osteotomy
• Scheduled to undergo sequential bilateral TKR under one anesthetic
• Scheduled to undergo revision TKR surgery
• Neuromuscular disorder limiting mobility or ability to comply with physiotherapy
• Previous recurrent deep knee infection
• Major bone loss requiring structural bone graft or augmented components
• Functionally limiting peripheral vascular disease
• Patients receiving associated worker's compensation benefits (WSIB)
• Ethanol/drug abuse/psychiatric disorder
• Inability or unwillingness to give written informed consent to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Soft Tissue Balancing; In the control group where the sensor device is not used in optimization of knee balance and alignment, definitive implants will be cemented in place and the sensor trial inserted using a thickness based on prior standard bearing insert trialing. Peak load data will be captured intraoperatively through full ROM. Custom shims will be affixed to the sensor to replicate thickness of the standard trial. The knee will then be cycled and loads recorded in the medial and lateral compartments at 10, 45 and 90 degrees of flexion. The surgeon will be blinded to the sensor output and the system will be located outside of their visual field.	Procedure: Standard Soft Tissue Balancing; Primary TKR with soft tissue balancing with a standard of care manual tensiometer device.; Other Names: Triathlon (Stryker, Mahwah, NJ)
Experimental: Sensor Guided Soft Tissue Balancing; In the experimental group where the sensor device is used to optimize balance and alignment, the sensor trial will be inserted and tibial baseplate rotated until medial and lateral femoral contact points are parallel on the sensor output. Quantitative balance is defined as a mediolateral intercompartmental loading difference of ≤15 pounds. Flexion balance is achieved when femoral contact point position is within the midposterior third of the tibial insert and intercompartmental loads are balanced. Loads in the medial and lateral compartments are recorded at 10, 45 and 90 degrees. If compartment loads differ by >15 lbs between compartments, unbalanced, further soft tissue release/bone resection will be done to achieve a side to side compartment pressure difference of <15 lbs through ROM.	Procedure: Sensor Guided Soft Tissue Balancing; Primary TKR with soft tissue balancing with a sensor guided device.; Other Names: Triathlon (Stryker, Mahwah, NJ); Verasense (OrthoSensor Inc., Dania Beach, FL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Unbalanced TKRs	The rate of unbalanced TKRs will be assessed based on the Verasense sensor device quantitative definition of a well balanced knee. A well balanced knee is defined as having a mediolateral intercompartmental loading difference of ≤15 pounds through ROM [Gustke et al., Walker et al].	Intraoperative at end of procedure prior to wound closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score	Overall clinical function as measured by Knee Society Score	Preoperative, 6 weeks, 6 months and 1 year postoperative
Oxford Knee Score	Subjective function as measured by Oxford Knee Score patient report outcome measure	Preoperative, 6 weeks, 6 months and 1 year postoperative
Patient satisfaction	Patient satisfaction with total knee replacement; likert scale	1 year postoperative
Clinical knee function: varus/valgus alignment	Assessment of clinical knee function	Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: anteroposterior stability	Assessment of clinical knee function	Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: extension lag	Assessment of clinical knee function	Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: anatomic alignment	Assessment of clinical knee function	Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative
Clinical knee function: knee ROM	Assessment of clinical knee function	Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Mitch Winemaker, MD, FRCSC, Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24.
• Walker PS, Meere PA, Bell CP. Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): September 3, 2020

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: range of motion; knee soft tissue balancing; sensor-guided
• Other Study ID Numbers: HAGRP01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No