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  • Does soft tissue balancing using intraoperative pressure sensors improve clinical outcomes in total knee arthroplasty? A protocol of a multicentre randomised controlled trial

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Surgery
Protocol
Does soft tissue balancing using intraoperative pressure sensors improve clinical outcomes in total knee arthroplasty? A protocol of a multicentre randomised controlled trial
  1. Samuel J MacDessi1,2,3,4,
  2. Aziz Bhimani5,6,
  3. Alexander W R Burns7,8,
  4. Darren B Chen1,2,
  5. Anthony K L Leong5,6,9,
  6. Robert B Molnar1,10,
  7. Jonathan S Mulford11,
  8. Richard M Walker12,13,
  9. Ian A Harris14,15,
  10. Ashish Diwan1,4,
  11. Jil A Wood3
  1. 1 Orthopaedic Surgery, St George Private Hospital, Kogarah, New South Wales, Australia
  2. 2 Orthopaedic Surgery, The Canterbury Hospital, Campsie, New South Wales, Australia
  3. 3 Clinical Research, Sydney Knee Specialists, Kogarah, New South Wales, Australia
  4. 4 St George Clinical School, University of New South Wales, Kogarah, NSW, Australia
  5. 5 Orthopaedic Surgery, Wollongong Private Hospital, Wollongong, New South Wales, Australia
  6. 6 Orthopaedic Surgery, Wollongong Public Hospital, Wollongong, New South Wales, Australia
  7. 7 Orthopaedic Surgery, Canberra Private Hospital, Deakin, Australian Capital Territory, Australia
  8. 8 Orthopaedic Surgery, Calvary John James Private Hospital, Deakin, Australian Capital Territory, Australia
  9. 9 Orthopaedic Surgery, Kareena Private Hospital, Caringbah, New South Wales, Australia
  10. 10 Orthopaedic Surgery, The Sutherland Hospital, Caringbah, New South Wales, Australia
  11. 11 Orthopaedic Surgery, Calvary St Luke’s Hospital, Launceston, Tasmania, Australia
  12. 12 Orthopaedic Surgery, Sydney Southwest Private Hospital, Liverpool, New South Wales, Australia
  13. 13 Orthopaedic Surgery, The Fairfield Hospital, Prairiewood, New South Wales, Australia
  14. 14 South West Sydney Clinical School, University of New South Wales, Liverpool, New South Wales, Australia
  15. 15 Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Liverpool, New South Wales, Australia
  1. Correspondence to Dr. Samuel J MacDessi; samuelmacdessi{at}sydneyknee.com.au

Abstract

Introduction Soft tissue imbalance is considered to be a major surgical cause of dissatisfaction following total knee arthroplasty (TKA). Surgeon-determined manual assessment of ligament tension has been shown to be a poor determinant of the true knee balance state. The recent introduction of intraoperative sensors, however, allows surgeons to precisely quantify knee compartment pressures and tibiofemoral kinematics, thereby optimising coronal and sagittal plane soft tissue balance. The primary hypothesis of this study is that achieving knee balance with use of sensors in TKA will improve patient-reported outcomes when compared with manual balancing.

Methods and analysis A multicentred, randomised controlled trial will compare patient-reported outcomes in 222 patients undergoing TKA using sensor-guided balancing versus manual balancing. The sensor will be used in both arms for purposes of data collection; however, surgeons will be blinded to the pressure data in patients randomised to manual balancing. The primary outcome will be the change from baseline to 1 year postoperatively in the mean of the four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) that are most specific to TKA recovery: pain, symptoms, function and knee-related quality of life. Secondary outcomes will include the surgeon’s capacity to determine knee balance, radiographic and functional measures and additional patient-reported outcomes. Normality of data will be assessed, and a Student’s t-test and equivalent non-parametric tests will be used to compare differences in means among the two groups.

Ethics and dissemination Ethics approval was obtained from South Eastern Sydney Local Health District, Approval (HREC/18/POWH/320). Results of the trial will be presented at orthopaedic surgical meetings and submitted for publication in a peer-reviewed journal.

Trial registration number ACTRN#12618000817246

  • total knee arthroplasty
  • intraoperative
  • soft-tissue balance

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-027812

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    Footnotes

    • Contributors SJM, DBC and IAH were involved in the conception and trial design. SJM and JAW were involved in drafting this article and will draft the study report. DBC, IAH, ADD, AB, AWRB, AKLL, RBM, JSM and RMW were involved in critical revision of this article for intellectual content. All authors will be involved in final approval of the study report. IAH provided statistical expertise. All authors will take the responsibility for study design; collection, management, analysis and interpretation of data; and decision to submit the report for publication.

    • Funding This work will be supported by grants from OrthoSensor (Dania Beach, Florida, USA) and Ramsay Hospital Research Foundation (Sydney, Australia) to cover costs of additional personnel (data collectors, data analyst, physiotherapists, radiographer), and by Smith and Nephew who will be providing the inserts needed to conduct this trial at no additional cost to patients. The grant will be held in a dedicated research account and administered through the Ingham Institute of Applied Medical Research (Liverpool, NSW).

    • Competing interests None of the participants in this study will be paid. None of the investigators has any financial or other conflicts of interest in the process of outcomes of this trial.

    • Ethics approval South-Eastern Sydney Local Health District Human Research Ethics Committee (HREC).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators Samuel MacDessi, Aziz Bhimani, Alexander Burns, Darren Chen, Anthony Leong, Robert Molnar, Jonathan Mulford, Richard Walker, Ian Harris, Ashish Diwan, Jil Wood

    • Patient consent for publication Not required.