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01-12-2022 | Knee-TEP | Study protocol

Robotic- and orthosensor-assisted versus manual (ROAM) total knee replacement: a study protocol for a randomised controlled trial

Authors: Nick D. Clement, Michelle Bardgett, Steven Galloway, Y. Jenny Baron, Karen Smith, David J. Weir, David J. Deehan

Published in: Trials | Issue 1/2022

Abstract

Background

Robotic-arm-assisted knee arthroplasty allows for more accurate component positioning and alignment and is associated with better patient-reported outcomes compared to manually performed jig-based knee arthroplasty. However, what is not known is whether the addition of an intra-articular sensor (Verasense^TM) to aid intraoperative balancing of the total knee replacement (TKR) offers improved functional outcomes for the patient. The purpose of this research is to compare the outcomes of patients undergoing a conventional manual knee replacement to those undergoing TKR using robotic-assisted surgery and the Verasense^TM to optimise alignment and balance the knee joint, respectively, and assess the associated cost economics of such technology.

Methods and analysis

This randomised controlled trial will include 90 patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the inclusion/exclusion criteria that consent to be in the study will be randomised at a ratio of 1:1 to either manual TKR (standard of care) or robotic-arm-assisted TKR with Verasense^TM to aid balancing of the knee. The primary objective will be functional improvement at 6 months following surgery between the two groups. The secondary objectives are to compare changes in knee-specific function, joint awareness, patient expectation and fulfilment, satisfaction, pain, stiffness and functional ability, health-related quality of life, cost-effectiveness, and gait patterns between the two groups. Ethical approval was obtained by the Tyne & Wear South Research Ethics Committee, UK. The study is sponsored by the Newcastle Hospitals NHS Foundation Trust.

Discussion

This study will assess whether the improved accuracy of component positioning using the robotic-arm-assisted surgery and the Verasense^TM to aid balancing of the TKR offers improved outcome relative to standard manual jig-based systems that are currently the standard of care. This will be assessed primarily according to knee-specific function, but several other measures will also be assessed including whether these are cost-effective interventions.

Trial registration

International Standard Randomised Controlled Trial Number ISRCTN47889316 https://doi.org/10.1186/ISRCTN47889316. Registered on 25 November 2019

Date and version for protocol

ROAM Protocol V1.0 (13-12-2018)

Available only for authorised users

Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, et al. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017;114(35):9332–6. https://doi.org/10.1073/pnas.1703856114.CrossRefPubMedPubMedCentral

Jenkins PJ, Clement ND, Hamilton DF, Gaston P, Patton JT, Howie CR. Predicting the cost-effectiveness of total hip and knee replacement: a health economic analysis. Bone Joint J. 2013;95-B(1):115–21. https://doi.org/10.1302/0301-620X.95B1.29835.CrossRefPubMed

Culliford DJ, Maskell J, Beard DJ, Murray DW, Price AJ, Arden NK. Temporal trends in hip and knee replacement in the United Kingdom: 1991 to 2006. J Bone Joint Surg Br. 2010;92(1):130–5. https://doi.org/10.1302/0301-620X.92B1.22654.CrossRefPubMed

Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006;452:35–43. https://doi.org/10.1097/01.blo.0000238825.63648.1e.CrossRefPubMed

Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002;404:7–13.CrossRef

Sultan AA, Piuzzi N, Khlopas A, Chughtai M, Sodhi N, Mont MA. Utilization of robotic-arm assisted total knee arthroplasty for soft tissue protection. Expert Rev Med Devices. 2017;14(12):925–7. https://doi.org/10.1080/17434440.2017.1392237.CrossRefPubMed

Hampp EL, Chughtai M, Scholl LY, Sodhi N, Bhowmik-Stoker M, Jacofsky DJ, et al. Robotic-arm assisted total knee arthroplasty demonstrated greater accuracy and precision to plan compared with manual techniques. J Knee Surg. 2018;32(3):239–250. https://doi.org/10.1055/s-0038-1641729.

Gustke KA, Golladay GJ, Roche MW, Jerry GJ, Elson LC, Anderson CR. Increased satisfaction after total knee replacement using sensor-guided technology. Bone Joint J. 2014;96-B(10):1333–8. https://doi.org/10.1302/0301-620X.96B10.34068.CrossRefPubMed

Picard F, Deep K, Jenny JY. Current state of the art in total knee arthroplasty computer navigation. Knee Surg Sports Traumatol Arthrosc. 2016;24(11):3565–74. https://doi.org/10.1007/s00167-016-4337-1.

10.

Marchand RC, Sodhi N, Khlopas A, Sultan AA, Harwin SF, Malkani AL, et al. Patient satisfaction outcomes after robotic arm-assisted total knee arthroplasty: a short-term evaluation. J Knee Surg. 2017;30(9):849–53. https://doi.org/10.1055/s-0037-1607450.CrossRefPubMed

11.

Kayani B, Konan S, Tahmassebi J, Pietrzak JRT, Haddad FS. Robotic-arm assisted total knee arthroplasty is associated with improved early functional recovery and reduced time to hospital discharge compared with conventional jig-based total knee arthroplasty. Bone Joint J. 2018;100-B(7):930–7. https://doi.org/10.1302/0301-620X.100B7.BJJ-2017-1449.R1.CrossRefPubMedPubMedCentral

12.

Cho KJ, Seon JK, Jang WY, Park CG, Song EK. Objective quantification of ligament balancing using VERASENSE in measured resection and modified gap balance total knee arthroplasty. BMC Musculoskelet Disord. 2018;19(1):266. https://doi.org/10.1186/s12891-018-2190-8.CrossRefPubMedPubMedCentral

13.

Daines BK, Dennis DA. Gap balancing vs. measured resection technique in total knee arthroplasty. Clin Orthop Surg. 2014;6(1):1–8. https://doi.org/10.4055/cios.2014.6.1.1.CrossRefPubMedPubMedCentral

14.

Clement ND, Macdonald D, Burgess AG, Howie CR. Articular surface mounted navigated total knee arthroplasty improves the reliability of component alignment. Knee Surg Sports Traumatol Arthrosc. 2017;26(5):1471-1477. https://doi.org/10.1007/s00167-017-4433-x.

15.

Clement ND, Deehan DJ. Knee biomechanics: will we ever know the truth? Bone Joint Res. 2018;7(5):325–6. https://doi.org/10.1302/2046-3758.75.BJR-2017-0360.CrossRefPubMedPubMedCentral

16.

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;29(5):955–60. https://doi.org/10.1016/j.arth.2013.10.020.CrossRefPubMed

17.

Marchand RC, Sodhi N, Khlopas A, Sultan AA, Higuera CA, Stearns KL, et al. Coronal correction for severe deformity using robotic-assisted total knee arthroplasty. J Knee Surg. 2017;31(1):2-5. https://doi.org/10.1055/s-0037-1608840.

18.

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–40.PubMed

19.

Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998;80(1):63–9. https://doi.org/10.1302/0301-620X.80B1.0800063.CrossRefPubMed

20.

Behrend H, Giesinger K, Giesinger JM, Kuster MS. The “forgotten joint” as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012;27(3):430–6. https://doi.org/10.1016/j.arth.2011.06.035.CrossRefPubMed

21.

Mancuso CA, Sculco TP, Wickiewicz TL, Jones EC, Robbins L, Warren RF, et al. Patients’ expectations of knee surgery. J Bone Joint Surg Am. 2001;83-A(7):1005–12. https://doi.org/10.2106/00004623-200107000-00005.CrossRef

22.

Scott CE, Bugler KE, Clement ND, MacDonald D, Howie CR, Biant LC. Patient expectations of arthroplasty of the hip and knee. J Bone Joint Surg Br. 2012;94(7):974–81. https://doi.org/10.1302/0301-620X.94B7.28219.CrossRefPubMed

23.

Mahomed N, Gandhi R, Daltroy L, Katz JN. The self-administered patient satisfaction scale for primary hip and knee arthroplasty. Arthritis. 2011;2011:591253–6. https://doi.org/10.1155/2011/591253.CrossRefPubMedPubMedCentral

24.

Brooks R. EuroQol: the current state of play. Health Policy. 1996;37(1):53–72. https://doi.org/10.1016/0168-8510(96)00822-6.CrossRefPubMed

25.

Dawson J, Beard DJ, McKibbin H, Harris K, Jenkinson C, Price AJ. Development of a patient-reported outcome measure of activity and participation (the OKS-APQ) to supplement the Oxford knee score. Bone Joint J. 2014;96-B(3):332–8. https://doi.org/10.1302/0301-620X.96B3.32845.CrossRefPubMed

26.

Giesinger K, Hamilton DF, Jost B, Holzner B, Giesinger JM. Comparative responsiveness of outcome measures for total knee arthroplasty. Osteoarthr Cartil. 2014;22(2):184–9. https://doi.org/10.1016/j.joca.2013.11.001.CrossRef

27.

Yoo JH, Chang CB, Kang YG, Kim SJ, Seong SC, Kim TK. Patient expectations of total knee replacement and their association with sociodemographic factors and functional status. J Bone Joint Surg Br. 2011;93(3):337–44. https://doi.org/10.1302/0301-620X.93B3.25168.CrossRefPubMed

28.

James M, St LS, Rowsell KV. Prioritising elective care: a cost utility analysis of orthopaedics in the north west of England. J Epidemiol Community Health. 1996;50(2):182–9. https://doi.org/10.1136/jech.50.2.182.CrossRefPubMedPubMedCentral

29.

Whiteside LA, Arima J. The anteroposterior axis for femoral rotational alignment in valgus total knee arthroplasty. Clin Orthop Relat Res. 1995;321(321):168–72. https://doi.org/10.1097/00003086-199512000-00026.CrossRef

30.

Wysocki RW, Sheinkop MB, Virkus WW, Della Valle CJ. Femoral fracture through a previous pin site after computer-assisted total knee arthroplasty. J Arthroplasty. 2008;23(3):462–5. https://doi.org/10.1016/j.arth.2007.03.019.CrossRefPubMed

31.

Hoke D, Jafari SM, Orozco F, Ong A. Tibial shaft stress fractures resulting from placement of navigation tracker pins. J Arthroplasty. 2011;26(3):504–8. https://doi.org/10.1016/j.arth.2010.05.009.CrossRefPubMed

32.

Owens RF Jr, Swank ML. Low incidence of postoperative complications due to pin placement in computer-navigated total knee arthroplasty. J Arthroplasty. 2010;25(7):1096–8. https://doi.org/10.1016/j.arth.2009.07.025.CrossRefPubMed

33.

Escobar A, Quintana JM, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthr Cartil. 2007;15(3):273–80. https://doi.org/10.1016/j.joca.2006.09.001.CrossRef

34.

Clement ND, Bardgett M, Weir D, Holland J, Gerrand C, Deehan DJ. What is the minimal clinically important difference for the WOMAC index after TKA? Clin Orthop Relat Res. 2018;476(10):2005–14. https://doi.org/10.1097/CORR.0000000000000444.CrossRefPubMedPubMedCentral

Title: Robotic- and orthosensor-assisted versus manual (ROAM) total knee replacement: a study protocol for a randomised controlled trial
Authors: Nick D. Clement
Michelle Bardgett
Steven Galloway
Y. Jenny Baron
Karen Smith
David J. Weir
David J. Deehan
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Knee-TEP
Knee-TEP
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05936-9

2024 ASCO Annual Meeting

Springer Medicine

Robotic- and orthosensor-assisted versus manual (ROAM) total knee replacement: a study protocol for a randomised controlled trial

Abstract

Background

Methods and analysis

Discussion

Trial registration

Date and version for protocol

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Methods and analysis

Discussion

Trial registration

Date and version for protocol

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