Retrospective Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Oct 18, 2020; 11(10): 431-441
Published online Oct 18, 2020. doi: 10.5312/wjo.v11.i10.431
Early clinical outcome and learning curve following unilateral primary total knee arthroplasty after introduction of a novel total knee arthroplasty system
Adam Omari, Anders Troelsen, Henrik Husted, Christian Skovgaard Nielsen, Kirill Gromov
Adam Omari, Department of Orthopedic Surgery, Copenhagen University Hvidovre Hospital, Copenhagen 2650, Denmark
Anders Troelsen, Henrik Husted, Christian Skovgaard Nielsen, Kirill Gromov, Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark
Author contributions: Omari A and Gromov K contributed equally to this work; Gromov K, Husted H and Troelsen A designed the research study; Omari A and Gromov K performed the research and data analysis; all authors contributed to writing the final manuscript; All authors have read and approve the final manuscript.
Institutional review board statement: Permission to store and review patient data was obtained from the Danish Data Protection Agency Jr, No. 2007-58-0015; No approval from the National Ethics Committee was necessary as this was a non-interventional observational study.
Informed consent statement: Patients were not required to give informed consent for this study as the analysis used anonymous data that were obtained after each patient agreed to treatment by written consent. Please find a signed document by all authors in our original submission.
Conflict-of-interest statement: Adam Omari, Christian Skovgaard Nielsen and Kirill Gromov have nothing to disclose; Anders Troelsen reports personal fees from Zimmer Biomet as a consultant and speaker, grants from Zimmer Biomet outside the submitted work, and has been a member of the board at the European Knee Society (EKS) since 2015; Henrik Husted reports personal fees from Zimmer Biomet as a speaker, and has been a board member of rapid recovery for Zimmer Biomet.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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 and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Adam Omari, MBBS, Academic Research, Department of Orthopedic Surgery, Copenhagen University Hvidovre Hospital, Kettegårds Alle 30, 2650 Hvidovre, Copenhagen 2650, Denmark. adam.omari.01@regionh.dk
Received: April 17, 2020
Peer-review started: April 18, 2020
First decision: August 9, 2020
Revised: August 18, 2020
Accepted: September 10, 2020
Article in press: September 10, 2020
Published online: October 18, 2020
ARTICLE HIGHLIGHTS
Research background

Globally, the use of total knee arthroplasty (TKA) has risen throughout the last 2-3 decades and is projected to increase even further. The introduction of novel implants for TKA is a frequent occurrence with proposed benefits for patients, but is unfortunately sometimes contradicted by evidence of undesirable effects with regard to revision rates, costs, and patient-perceived outcomes. Little information exists on how early surgical outcome and implant positioning are affected following the introduction of a novel TKA system.

Research motivation

This study focused on the early logistical challenges posed by the introduction of a novel TKA system. In particular, the short-term clinical outcomes in patients with emphasis on how surgery-related factors and implant positioning are affected following the introduction of a novel TKA system. The utilization rate across surgeons and how surgical experience with the implant affects outcome were investigated.

Research objectives

This short-term study showed that a learning curve is present even for experienced knee surgeons following the introduction of a novel knee system. Information from this study may help to increase care when introducing new procedures and logistical considerations when choosing a novel implant, as small gains in alignment should be balanced against inferior peri-operative outcomes. These findings will be useful as a basis for comparisons for future studies and correlations with patient reported outcomes.

Research methods

This retrospective study included 212 TKA patients undergoing surgery at Copenhagen University Hospital Hvidovre. We included 75 consecutive knees treated with the novel TKA system in the introduction period starting from November 30th 2015 immediately following implementation by three experienced surgeons (25 TKAs/surgeon), along with a control group of 75 patients. A Follow-up Group consisting of 62 consecutive knees starting from 365-d after each respective surgeon ended their initial 25 novel TKAs was also included. Patient demographics, surgery-related factors and alignment data were recorded using the institution’s patient registry.

Research results

This study examined how early clinical outcome, implant positioning and utilization rate were affected by the introduction of a novel TKA system between August 2015–December 2018, and how increased surgical experience with the implant affected patient outcome. The novel TKA system was utilized in 69% (71%), 53% (54%), and 45% (75%) of primary TKA procedures by the three surgeons, respectively (Follow-up Group). Mean surgery time was increased by 28% and mean intra-operative blood loss by 25% in the Introduction Group, whereas only the mean surgery time was increased in the Follow-up Group by 18%. Small improvements were observed in alignment. FF outliers were reduced in the Introduction Group with a more pronounced decrease in the Follow-up Group.

Research conclusions

Little information exists on how early surgical outcome is affected following the introduction of a novel TKA system. This study brings a unique view on short-term outcome following the introduction of a novel TKA system in relation to implant positioning, early clinical outcome and the learning curve. It accounts for variances between surgeons by studying the same experienced orthopedic surgeons throughout the study, as surgical skill, experience, and caseload varies across surgeons. Increased surgical time and intraoperative blood loss was observed immediately after introduction of the new system. These differences diminished one year after introduction of the new implant.  Our findings suggest that surgeons should take increased care when introducing new procedures and consider the logistics when choosing a novel implant, as small gains in alignment should be balanced against inferior peri-operative outcomes.

Research perspectives

Further studies are needed to investigate if these differences persist over time and correlate with patient reported outcomes.