Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial

Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob, Peter D Moriarty, Fares S Haddad, Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob, Peter D Moriarty, Fares S Haddad

Abstract

Background: There remains a paucity of clinical studies assessing how any differences in accuracy of implant positioning between robotic-arm assisted unicompartmental knee arthroplasty (RO UKA) and conventional jig-based unicompartmental knee arthroplasty (CO UKA) translate to patient satisfaction, functional outcomes, and implant survivorship. The objectives of this study are to compare accuracy of implant positioning, limb alignment, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in CO UKA versus RO UKA. Computer navigation will be used to assess intraoperative knee kinematics in all patients undergoing CO UKA.

Methods and analysis: This prospective randomised controlled trial will include 140 patients with symptomatic medial compartment knee arthritis undergoing primary UKA. Following informed consent, patients will be randomised to CO UKA (control group) or RO UKA (investigation group) at a ratio of 1:1 using an online random number generator. The primary objective of this study is to compare accuracy of implant positioning in CO UKA versus RO UKA. The secondary objectives are to compare the following outcomes between the two treatment groups: limb alignment, surgical efficiency, postoperative functional rehabilitation, functional outcomes, quality of life, range of motion, resource use, cost effectivness, and complications. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes pertaining to these objectives. Ethical approval was obtained from the London-Bloomsbury Research Ethics Committee, UK. The study is sponsored by University College London, UK.

Discussion: This study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CO UKA versus RO UKA. The findings of this study will provide an improved understanding of the differences in CO UKA versus RO UKA with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.

Trial registration: ClinicalTrials.gov NCT04095637 . Registered on 19 September 2019.

Conflict of interest statement

FSH reports board membership of the Bone and Joint Journal and the Annals of the Royal College of Surgeons; consultancy for Smith & Nephew, Corin, MatOrtho and Stryker; payment for lectures including service on speakers’ bureaus for Smith & Nephew and Stryker; and royalties paid by Smith & Nephew, MatOrtho, Corin and Stryker, all outside the submitted work.

SK reports consultancy, payment for lectures including service on speakers’ bureaus, payment for development of education presentations, and travel/accommodations/ meeting expenses for Smith and Nephew and AO, all outside the submitted work.

All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Patient enrolment flow chart
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments for all study patients. CO UKA, conventional jig-based unicompartmental knee arthroplasty; RO UKA, robotic-arm-assisted unicompartmental knee arthroplasty; CT, computerised tomography

References

    1. No authors listed. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. 16th Annual Report 2019. . Accessed 22 May 2020.
    1. Ackroyd CE. Medial compartment arthroplasty of the knee. J Bone Joint Surg (Br) 2003;85(7):937–942. doi: 10.1302/0301-620X.85B7.14650.
    1. Batailler C, White N, Ranaldi FM, et al. Improved implant position and lower revision rate with robotic-assisted unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019;27(4):1232–1240. doi: 10.1007/s00167-018-5081-5.
    1. Bell SW, Anthony I, Jones B, et al. Improved accuracy of component positioning with robotic-assisted unicompartmental knee arthroplasty: data from a prospective, randomized controlled study. J Bone Joint Surg Am. 2016;98(8):627–635. doi: 10.2106/JBJS.15.00664.
    1. Blaney J, Harty H, Doran E, et al. Five-year clinical and radiological outcomes in 257 consecutive cementless Oxford medial unicompartmental knee arthroplasties. Bone Joint J. 2017;99-b(5):623–631. doi: 10.1302/0301-620X.99B5.BJJ-2016-0760.R1.
    1. Blyth MJG, Anthony I, Rowe P, et al. Robotic arm-assisted versus conventional unicompartmental knee arthroplasty: exploratory secondary analysis of a randomised controlled trial. Bone Joint Res. 2017;6(11):631–639. doi: 10.1302/2046-3758.611.BJR-2017-0060.R1.
    1. Bradley B, Middleton S, Davis N, et al. Discharge on the day of surgery following unicompartmental knee arthroplasty within the United Kingdom NHS. Bone Joint J. 2017;99-b(6):788–792. doi: 10.1302/0301-620X.99B6.BJJ-2016-0540.R2.
    1. Burn E, Liddle AD, Hamilton TW, et al. Cost-effectiveness of unicompartmental compared with total knee replacement: a population-based study using data from the National Joint Registry for England and Wales. BMJ Open. 2018;8(4):e020977. doi: 10.1136/bmjopen-2017-020977.
    1. Chalmers BP, Mehrotra KG, Sierra RJ, et al. Reliable outcomes and survivorship of unicompartmental knee arthroplasty for isolated compartment osteonecrosis. Bone Joint J. 2018;100-b(4):450–454. doi: 10.1302/0301-620X.100B4.BJJ-2017-1041.R2.
    1. Cobb J, Henckel J, Gomes P, et al. Hands-on robotic unicompartmental knee replacement: a prospective, randomised controlled study of the acrobot system. J Bone Joint Surg (Br) 2006;88(2):188–197. doi: 10.1302/0301-620X.88B2.17220.
    1. Gandek B, Ware JE, Aaronson NK, et al. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998;51(11):1171–1178. doi: 10.1016/S0895-4356(98)00109-7.
    1. Garratt AM, Brealey S, Gillespie WJ. Patient-assessed health instruments for the knee: a structured review. Rheumatology (Oxford) 2004;43(11):1414–1423. doi: 10.1093/rheumatology/keh362.
    1. Gaudiani MA, Nwachukwu BU, Baviskar JV, et al. Optimization of sagittal and coronal planes with robotic-assisted unicompartmental knee arthroplasty. Knee. 2017;24(4):837–843. doi: 10.1016/j.knee.2017.05.002.
    1. Gilmour A, MacLean AD, Rowe PJ, et al. Robotic-arm-assisted vs conventional unicompartmental knee arthroplasty. The 2-year clinical outcomes of a randomized controlled trial. J Arthroplast. 2018;33(7s):S109–s115. doi: 10.1016/j.arth.2018.02.050.
    1. Hamilton TW, Pandit HG, Inabathula A, et al. Unsatisfactory outcomes following unicompartmental knee arthroplasty in patients with partial thickness cartilage loss: a medium-term follow-up. Bone Joint J. 2017;99-b(4):475–482. doi: 10.1302/0301-620X.99B4.BJJ-2016-1061.R1.
    1. Hamilton TW, Pandit HG, Maurer DG, et al. Anterior knee pain and evidence of osteoarthritis of the patellofemoral joint should not be considered contraindications to mobile-bearing unicompartmental knee arthroplasty: a 15-year follow-up. Bone Joint J. 2017;99-b(5):632–639. doi: 10.1302/0301-620X.99B5.BJJ-2016-0695.R2.
    1. Haywood KL, Garratt AM, Fitzpatrick R. Quality of life in older people: a structured review of generic self-assessed health instruments. Qual Life Res. 2005;14(7):1651–1668. doi: 10.1007/s11136-005-1743-0.
    1. Herry Y, Batailler C, Lording T, et al. Improved joint-line restitution in unicompartmental knee arthroplasty using a robotic-assisted surgical technique. Int Orthop. 2017;41(11):2265–2271. doi: 10.1007/s00264-017-3633-9.
    1. Hossain FS, Patel S, Fernandez MA, et al. A performance based patient outcome score for active patients following total knee arthroplasty. Osteoarthr Cartil. 2013;21(1):51–59. doi: 10.1016/j.joca.2012.09.019.
    1. Isaac SM, Barker KL, Danial IN, et al. Does arthroplasty type influence knee joint proprioception? A longitudinal prospective study comparing total and unicompartmental arthroplasty. Knee. 2007;14(3):212–217. doi: 10.1016/j.knee.2007.01.001.
    1. Jeer PJ, Cossey AJ, Keene GC. Haemoglobin levels following unicompartmental knee arthroplasty: influence of transfusion practice and surgical approach. Knee. 2005;12(5):358–361. doi: 10.1016/j.knee.2004.11.006.
    1. Jenkinson C, Chandola T, Coulter A, et al. An assessment of the construct validity of the SF-12 summary scores across ethnic groups. J Public Health Med. 2001;23(3):187–194. doi: 10.1093/pubmed/23.3.187.
    1. Johal P, Hassaballa MA, Eldridge JD, et al. The posterior condylar offset ratio. Knee. 2012;19(6):843–845. doi: 10.1016/j.knee.2012.03.017.
    1. Kayani B, Konan S, Horriat S, et al. Posterior cruciate ligament resection in total knee arthroplasty: the effect on flexion-extension gaps, mediolateral laxity, and fixed flexion deformity. Bone Joint J. 2019;101-b(10):1230–1237. doi: 10.1302/0301-620X.101B10.BJJ-2018-1428.R2.
    1. Kayani B, Konan S, Pietrzak JRT, et al. Iatrogenic bone and soft tissue trauma in robotic-arm assisted total knee arthroplasty compared with conventional jig-based total knee arthroplasty: a prospective cohort study and validation of a new classification system. J Arthroplast. 2018;33(8):2496–2501. doi: 10.1016/j.arth.2018.03.042.
    1. Kayani B, Konan S, Pietrzak JRT, et al. The learning curve associated with robotic-arm assisted unicompartmental knee arthroplasty: a prospective cohort study. Bone Joint J. 2018;100-b(8):1033–1042. doi: 10.1302/0301-620X.100B8.BJJ-2018-0040.R1.
    1. Kayani B, Konan S, Tahmassebi J, et al. An assessment of early functional rehabilitation and hospital discharge in conventional versus robotic-arm assisted unicompartmental knee arthroplasty: a prospective cohort study. Bone Joint J. 2019;101-b(1):24–33. doi: 10.1302/0301-620X.101B1.BJJ-2018-0564.R2.
    1. Koskinen E, Eskelinen A, Paavolainen P, et al. Comparison of survival and cost-effectiveness between unicondylar arthroplasty and total knee arthroplasty in patients with primary osteoarthritis: a follow-up study of 50,493 knee replacements from the Finnish Arthroplasty Register. Acta Orthop. 2008;79(4):499–507. doi: 10.1080/17453670710015490.
    1. Liddle AD, Judge A, Pandit H, et al. Adverse outcomes after total and unicompartmental knee replacement in 101,330 matched patients: a study of data from the National Joint Registry for England and Wales. Lancet. 2014;384(9952):1437–1445. doi: 10.1016/S0140-6736(14)60419-0.
    1. Liddle AD, Pandit H, Judge A, et al. Optimal usage of unicompartmental knee arthroplasty: a study of 41,986 cases from the National Joint Registry for England and Wales. Bone Joint J. 2015;97-b(11):1506–1511. doi: 10.1302/0301-620X.97B11.35551.
    1. Liddle AD, Pandit H, Judge A, et al. Patient-reported outcomes after total and unicompartmental knee arthroplasty: a study of 14,076 matched patients from the National Joint Registry for England and Wales. Bone Joint J. 2015;97-b(6):793–801. doi: 10.1302/0301-620X.97B6.35155.
    1. Liddle AD, Pandit H, Judge A, et al. Effect of surgical caseload on revision rate following total and unicompartmental knee replacement. J Bone Joint Surg Am. 2016;98(1):1–8. doi: 10.2106/JBJS.N.00487.
    1. Moschetti WE, Konopka JF, Rubash HE, et al. Can robot-assisted unicompartmental knee arthroplasty be cost-effective? A Markov decision analysis. J Arthroplast. 2016;31(4):759–765. doi: 10.1016/j.arth.2015.10.018.
    1. Murray DW, Liddle AD, Judge A, et al. Bias and unicompartmental knee arthroplasty. Bone Joint J. 2017;99-b(1):12–15. doi: 10.1302/0301-620X.99B1.BJJ-2016-0515.R1.
    1. Murray DW, Parkinson RW. Usage of unicompartmental knee arthroplasty. Bone Joint J. 2018;100-b(4):432–435. doi: 10.1302/0301-620X.100B4.BJJ-2017-0716.R1.
    1. Pearle AD, van der List JP, Lee L, et al. Survivorship and patient satisfaction of robotic-assisted medial unicompartmental knee arthroplasty at a minimum two-year follow-up. Knee. 2017;24(2):419–428. doi: 10.1016/j.knee.2016.12.001.
    1. Ponzio DY, Lonner JH. Robotic technology produces more conservative tibial resection than conventional techniques in UKA. Am J Orthop (Belle Mead NJ) 2016;45(7):E465–e468.
    1. Walker T, Zahn N, Bruckner T, et al. Mid-term results of lateral unicondylar mobile bearing knee arthroplasty: a multicentre study of 363 cases. Bone Joint J. 2018;100-b(1):42–49. doi: 10.1302/0301-620X.100B1.BJJ-2017-0600.R1.
    1. Ware J, Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–233. doi: 10.1097/00005650-199603000-00003.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner