A blinded, three-arm randomised trial assessing joint function and measuring three-dimensional knee joint kinematics in individuals six months after a total knee joint replacement; comparing a medially stabilised design, to standard fixed bearing conventional designs – posterior stabilising and cruciate retaining

Michelle M. Dowsey, Marcus Pandy, Tony J. Young, Hans Gray, Shangyuanye Guan, Peter F. Choong


Background: No randomised trial exists to assess the relative prosthetic performance of three fixed bearing total knee joint replacement construct designs through clinical functional outcomes and biomechanical gait analysis at six months after the index procedure.

Methods: The design of a double blinded, prospective, randomised trial with three parallel patient groups is presented.   Patients reviewed in consultant clinic with radiographic and clinical diagnosis of osteoarthritis of the knee, with the condition deemed severe enough to require a total knee joint replacement (TKJR) are eligible.  Subjects enrolled in the trial are randomised to one of the three TKJR construct designs approximately ten days prior to scheduled date of surgery.  Each subject is then followed up for at least twelve months.  Repeated measure of Analysis of Variance (ANOVA), and Analysis of Covariance (ANCOVA) will be utilised to uncover any clinical functional differences in each trial group in each time interval.

Results: Differences in clinical functional scores at each time interval compared to pre-intervention, as well as between group differences in clinical functional scores at each time interval will be examined.  At six months after the operation, biomechanical measurements of joint motion, ground reaction forces, and muscle electromyographic (EMG) activity will be recorded simultaneously from each subject for four test conditions: level walking, stair ascent, stair descent, and chair rise.

Conclusions: This randomised trial is designed to better understand the relationships between the clinical functional outcomes and replaced knee kinematics in three fixed bearing total knee replacement construct designs at six months postoperatively.


Outcome, Knee prosthetic design, Osteoarthritis, Patient reported outcome measure

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Australian Orthopaedic Association National Joint Replacement Registry. Annual Report 2012. Available at: https: //aoanjrr.drmac.adelaide.edu.au. Accessed on 3 October 2017.

Australian Orthopaedic Association National Joint Replacement Registry. Annual Report 2016. Available at: https://aoanjrr.drmac.adelaide.edu.au. Accessed on 3 October 2017.

Fitch DA, Sedacki K, Yang Y. Mid- to long-term outcomes of a medial-pivot system for primary total knee replacement a systematic review and meta-analysis. Bone Joint Res. 2014;3:297-304.

Pinskerova V, Freeman M. Cadaver test and MRI kinematic study of the flat lateral and congruent lateral tibial inserts of the GMK® sphere implant. M.O.R.E. 2012;2:26-31.

Hinarejos P, Puig-Verdie L, Pelfort X, Torres-Claramunt R, Sánchez-Soler J, Monilau J. No differences in functional results and quality of life after single-radius or multiradii TKA. Knee Surg Sports Traumatol Arthrosc. 2016;24(8):2634-40.

Cook LE, Klika AK, Szubski CR, Rosneck J, Molloy R, Barsoum WK. Funtional outcomes used to compare single radius and multiradius of curvature designs in total knee arthroplasty. J Knee Surg. 2012;25:249-54.

Kim YH, Kim JS, Choe JW, Kim HJ. Long term comparisons of fixed-bearing and mobile-bearing total knee replacements in patients younger than fifty-one years of age with osteoarthritis. J Bone J Surg Am. 2012;94(10):866-73.

Ball ST, Sanchez HB, Mahoney OM. Schmalzried TP. Fixed versus rotating platform total knee arthroplasty: a prospective, randomized, single-blinded Study. J Arthroplast. 2011;26(4):531-6.

Insall JN, Lachiewicz PF, Burstein AH. The posterior stabilized condylar prosthesis:a modification of the total condylar design:two to four- year clinical experience. J Bone Joint Surg Am. 1982;64:1317-23.

Kolisek FR, McGrath MS, Marker DR, Jessup N, Seyler TM, Mont MA, et al. Posterior-stabilised versus posterior cruciate ligament-retaining total knee arthroplasty. Iowa Orthop J. 2009;29:23-7.

Wolterbeek N, Nelissen RG, Valstar ER. No differences in in-vivo kinematics between six different types of knee prostheses. Knee Surg Sports Traumatol Arthrosc. 2012;20:559-64.

Shakespeare D, Ledger M, Kinzel V. Flexion after total knee replacement:a comparison between the medial stablised knee and a posterior stabilised implant. Knee. 2006;13:371-3.

Dolan MM, Kelly NH, Nguyen JT, Wright TM, Haas S. Implant design influences tibial post wear damage in posterior- stabilised knees. Clin Orthop Relat Res. 2011;469:160-7.

Comfort T, Baste V, Froufe MA, Namba R, Bordini B, Robertsson O, et al. International comparative evaluation of fixed–bearing non- posterior– stabilized and posterior– stabilized total knee replacement. J Bone Joint Surg Am. 2014;96 Suppl 1(E):65-72.

Peters CL, Mulkey P, Erickson J, Anderson MB, Pelt CE. Comparison of total knee arthroplasty with highly congruent anterior– stabilized bearings versus a cruciate-retaining design. Clin Orthop Relat Res. 2014;472(1):175-80.

Giesinger K, Hamilton DF, Jost B, Hozner B, Giesinger JM. Comparative responsiveness of outcome measures for total knee arthroplasty. Osteoarthritis and Cartilage. 2014;22:184-9.

Pinskerova V, Samuelson, KM, Stammers J, Maruthainar K, Sosna A, Freeman MA. The knee in full flexion– an anatomical study. J Bone Joint Surg Br. 2009;91B:830-4.

Scott G, Iman MA, Elfert A, Freeman MA, Pinskerova V, Field RE, et al. Can a total knee arthroplasty be both rotationally unconstrained and anteroposteriorly stabilised? Bone J Res. 2016;5:80-6.

Jones CA, Beaupre LA, Johnston DW, Suarez-Almazor ME. Total joint arthroplasties:current concepts of patient outcomes after surgery. Rheum Dis Clin North Am. 2007;33(1):71-86.

Noble PC, Scuderi GR, Brekkee AC, Sikorskii A, Benjamin JB, Lonner JH, et al. Development of a new knee society scoring system. Clin Orthop Relat Res. 2012;470(1):20-32.

Ramkumar PN, Harris JD, Noble PC. Patient- reported outcome measures after total knee arthroplasty:a systematic review. Bone Joint Res. 2015;4:120-7.

Ko Y, Lo NN, Yeo SJ, Yang KY, Yeo W, Chong HC, et al. Comparison of the responsiveness of the SF-36, the Oxford knee score, and the knee society clinical rating system in patients undergoing total knee replacement. Qual Life Res. 2013;22:2455-9.

Digennarro V, Zambianchi F, Marcovigi A, Mugnai R, Fiacchi F, Catani F. Design and kinematics in total knee arthroplasty. Int Orthop. 2014;38:227-33.

Stiehl JB. Knee kinematics and mobile bearings: new design considerations. Current Opinion Orthop. 2001;12:18-25.

Ackland DC, Keynejad F, Pandy M. Future trends in the use of x ray fluoroscopy for the measurement and modelling of joint motion. Proceedings of the Institution of Mechanical Engineers, Part H: J Eng Med. 2011;225(12):1136-48.

Guan S, Gray H, Keynejad F, Pandy M. Mobile biplane x-ray imaging system for measuring 3D dynamic joint motion during overground gait. IEEE T Medical Imaging. 2016;35(1):326-36.

Moher D, Schulz KF, Altman D. The CONSORT statement:revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285(15):1987-91.

Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures:a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskeletal Disorders. 2005;6:3.

Hsu RW, Himeno S, Coventry MB, Chao EY. Normal axial alignment of the lower extremity and load-bearing distribution at the knee. Clin Orthop Relat Res. 1990;(255):215-27.

Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM. Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004;86(6):818-23.

Dorn TW, Schache AG, Pandy MG. Muscular strategy shift in human running:dependence of running speed on hip and ankle muscle performance. J Exp Biol. 2012;215:1944–56.

Delp SL, Anderson FC, Arnold AS, Loan P, Habib A, John CT, et al. OpenSim:open‐source software to create and analyze dynamic simulations of movement. IEEE Trans Biomed Eng. 2007;54:1940–50.

Hossain F, Patel S, Rhee SJ, Haddad FS. Knee arthroplasty with a medially conforming ball-and-socket tibiofemoral articulation provides better function. Clin Orthop Relat Res. 2011;469:55-63.

Ishida K, Matsumoto T, Tsumura N, Iwakura T, Kubo S, Tetsuhiro I, et al. No difference between double-high Insert and medial– pivot insert in TKA. Knee Surg Sports Traumatol Arthrosc. 2014;22:21-5.

Insall JN, Ranawat CS, Aglietti P Shine J. A comparison of four models of total knee replacement prostheses. J Bone Joint Surg Am. 1976;58:754-765.

Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the knee society clinical rating system. Clin Orthop Relat Res. 1989;248:13-4.

The Knee Society Outcomes Assessment. Available at: https:www.kneesociety.org/web/outcome.html.

Bellamy N. Osteoarthritis- an evaluative index for clinical trials. MSc. Thesis. 1982. McMaster University, Hamilton, Ontario, Canada.

Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty:who is satisfied and who is not? Clin Orthop Relat Res. 2010;468:57–63.

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 following total hip and knee arthroplasty in osteoarthritis. J Orthop Rheumatol. 1988;1:95-108.

Bachmeier CJM, March LM, Cross MJ, Lapsley HM, Tribe KL, Courtenay BG, et al. A comparison of outcomes in osteoarthritis patients undergoing total hip and knee replacement surgery. Osteoarthritis and Cartilage. 2001;9:137-46.

Escobar A, Quintana JM, Bilbao A, Arôstegui I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis and Cartilage 2007;15(3):273–80.

Dawson, J, Fitzpatrick R, Murray D, Carr. A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br 1998;80:63-9.