Conventional vs. Sensor Guided Soft Tissue Balancing in TKA RCT

NCT02976428 | Completed

• 1 other identifier: HAGRP01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty

Keywords

knee soft tissue balancing; sensor-guided; range of motion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Knee Society Score

  Preoperative, 6 weeks, 6 months and 1 year postoperative

• Oxford Knee Score

  Preoperative, 6 weeks, 6 months and 1 year postoperative

• Patient satisfaction

  1 year postoperative

• Clinical knee function: varus/valgus alignment

  Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative

• Clinical knee function: anteroposterior stability

  Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative

Study Arms (2)

Standard Soft Tissue Balancing

ACTIVE COMPARATOR

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

Sensor Guided Soft Tissue Balancing

EXPERIMENTAL

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

Interventions

Sensor Guided Soft Tissue Balancing PROCEDURE

Primary TKR with soft tissue balancing with a sensor guided device.

Also known as: Triathlon (Stryker, Mahwah, NJ), Verasense (OrthoSensor Inc., Dania Beach, FL)

Sensor Guided Soft Tissue Balancing

Standard Soft Tissue Balancing PROCEDURE

Primary TKR with soft tissue balancing with a standard of care manual tensiometer device.

Also known as: Triathlon (Stryker, Mahwah, NJ)

Standard Soft Tissue Balancing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (2)

• 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.

  PMID: 24269069 BACKGROUND

• 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.

  PMID: 24103411 BACKGROUND

Study Officials

• Mitch Winemaker, MD, FRCSC

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Orthopedic Surgery, Hamilton Health Sciences Juravinski Hospital

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: February 1, 2017
• Primary Completion: May 15, 2018
• Study Completion: September 3, 2020
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)