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Completed

NCT Number: NCT02976428

Conventional vs. Sensor Guided Soft Tissue Balancing in TKA RCT

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensor Guided Soft Tissue Balancing

Procedure

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

Other names: Triathlon (Stryker, Mahwah, NJ), Verasense (OrthoSensor Inc., Dania Beach, FL)

Standard Soft Tissue Balancing

Procedure

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

Other names: Triathlon (Stryker, Mahwah, NJ)

Primary outcomes

  1. Rate of Unbalanced TKRs

    Time frame: Intraoperative at end of procedure prior to wound closure

    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].

Secondary outcomes

  1. Knee Society Score

    Time frame: Preoperative, 6 weeks, 6 months and 1 year postoperative

    Overall clinical function as measured by Knee Society Score

  2. Oxford Knee Score

    Time frame: Preoperative, 6 weeks, 6 months and 1 year postoperative

    Subjective function as measured by Oxford Knee Score patient report outcome measure

  3. Patient satisfaction

    Time frame: 1 year postoperative

    Patient satisfaction with total knee replacement; likert scale

  4. Clinical knee function: varus/valgus alignment

    Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative

    Assessment of clinical knee function

  5. Clinical knee function: anteroposterior stability

    Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative

    Assessment of clinical knee function

  6. Clinical knee function: extension lag

    Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative

    Assessment of clinical knee function

  7. Clinical knee function: anatomic alignment

    Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative

    Assessment of clinical knee function

  8. Clinical knee function: knee ROM

    Time frame: Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative

    Assessment of clinical knee function

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Nov 29, 2016
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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