Comparative evaluation of minimally invasive 'tibial tuberoplasty' surgical technique versus conventional open surgery for Schatzker II-III tibial plateau fractures: design of a multicentre, randomised, controlled and blinded trial (TUBERIMPACT study)

Tanguy Vendeuvre, Olivier Monlezun, Claire Brandet, Pierre Ingrand, Isabelle Durand-Zaleski, Louis-Etienne Gayet, Arnaud Germaneau, Frederic Khiami, Manuel Roulaud, Guillaume Herpe, Philippe Rigoard, Tanguy Vendeuvre, Olivier Monlezun, Claire Brandet, Pierre Ingrand, Isabelle Durand-Zaleski, Louis-Etienne Gayet, Arnaud Germaneau, Frederic Khiami, Manuel Roulaud, Guillaume Herpe, Philippe Rigoard

Abstract

Introduction: Fractures of the tibial plateau are in constant progression. They affect an elderly population suffering from a number of comorbidities, but also a young population increasingly practicing high-risk sports. The conventional open surgical technique used for tibial plateau fractures has several pitfalls: bone and skin devascularisation, increased risks of infection and functional rehabilitation difficulties. Since 2011, Poitiers University Hospital is offering to its patients a new minimally invasive technique for the reduction and stabilisation of tibial plateau fractures, named 'tibial tuberoplasty'. This technique involves expansion of the tibial plateau through inflation using a kyphoplasty balloon, filling of the fracture cavity with cement and percutaneous screw fixation. We designed a study to evaluate the quality of fracture reduction offered by percutaneous tuberoplasty versus conventional open surgery for tibial plateau fracture and its impact on clinical outcome.

Methods and analysis: This is a multicentre randomised controlled trial comparing two surgical techniques in the treatment of tibial plateau fractures. 140 patients with a Schatzker II or III tibial plateau fracture will be recruited in France. They will be randomised either in tibial tuberoplasty arm or in conventional surgery arm. The primary outcome is the postoperative radiological step-off reduction blindly measured on CT scan (within 48 hours post-op). Additional outcomes include other radiological endpoints, pain, functional abilities, quality of life assessment and health-economic endpoints. Outcomes assessment will be performed at baseline (before surgery), at day 0 (surgery), at 2, 21, 45 days, 3, 6, 12 and 24 months postsurgery.

Ethics and dissemination: This study has been approved by the ethics committee Ile-De-France X and will be conducted in accordance with current Good Clinical Practice (GCP) guidelines, Declaration of Helsinki and standard operating procedures. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.

Trial registration number: Clinicaltrial.gov:NCT03444779.

Keywords: balloon reduction; minimally invasive surgery; randomised controlled trial; tibial plateau fracture.

Conflict of interest statement

Competing interests: TV has received consultancy honoraria from Medtronic and Depuy-Synthes. PR is a consultant for Medtronic. He also received honoraria for medical training and research grants from Medtronic. ID-Z has received grants from ministry of health. All other coauthors (OM, CB, MR, GH, AG, L-EG, PI and FK).

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Tuberoplasty entry point (adapted from Hannouche et al13).
Figure 3
Figure 3
Fluoroscopy of tibial plateau fracture reduction by tuberoplasty (from Vendeuvre et al8).
Figure 4
Figure 4
A radiological comparison between standard X-ray and CT scan (adapted from Haller et al22).

References

    1. Site Internet. Accès aux bases PMSI. Available:
    1. Schatzker J, McBroom R, Bruce D. The tibial plateau fracture. The Toronto experience 1968--1975. Clin Orthop Relat Res 1979;(138):94–104.
    1. Young MJ, Barrack RL. Complications of internal fixation of tibial plateau fractures. Orthop Rev 1994;23:149–54.
    1. Hsu C-J, Chang W-N, Wong C-Y. Surgical treatment of tibial plateau fracture in elderly patients. Arch Orthop Trauma Surg 2001;121:67–70. 10.1007/s004020000145
    1. Roßbach BP, Faymonville C, Müller LP, et al. . [Quality of life and job performance resulting from operatively treated tibial plateau fractures]. Unfallchirurg 2016;119:27–35. 10.1007/s00113-014-2618-z
    1. Giannoudis PV, Tzioupis C, Papathanassopoulos A, et al. . Articular step-off and risk of post-traumatic osteoarthritis. Evidence today. Injury 2010;41:986–95. 10.1016/j.injury.2010.08.003
    1. Volpin G, Dowd GS, Stein H, et al. . Degenerative arthritis after intra-articular fractures of the knee. long-term results. J Bone Joint Surg Br 1990;72-B:634–8. 10.1302/0301-620X.72B4.2380219
    1. Vendeuvre T, Babusiaux D, Brèque C, et al. . Tuberoplasty: minimally invasive osteosynthesis technique for tibial plateau fractures. Orthop Traumatol Surg Res 2013;99(4 Suppl):S267–S272. 10.1016/j.otsr.2013.03.009
    1. Burdin G. Arthroscopic management of tibial plateau fractures: surgical technique. Orthop Traumatol Surg Res 2013;99(1 Suppl):S208–S218. 10.1016/j.otsr.2012.11.011
    1. Durakbasa MO, Kose O, Ermis MN, et al. . Measurement of lateral plateau depression and lateral plateau widening in a Schatzker type II fracture can predict a lateral meniscal injury. Knee Surg Sports Traumatol Arthrosc 2013;21:2141–6. 10.1007/s00167-012-2195-z
    1. Hashemi J, Chandrashekar N, Gill B, et al. . The geometry of the tibial plateau and its influence on the biomechanics of the Tibiofemoral joint. J Bone Joint Surg Am 2008;90:2724–34. 10.2106/JBJS.G.01358
    1. Canale ST, Beaty JH, Campbell WC, et al. . Campbell’ s operative orthopaedics: [get full access and more at . 12th edn Philadelphia, Pa: Elsevier, Mosby, 2013.
    1. Hannouche D, Duparc F, Beaufils P. The arterial vascularization of the lateral tibial condyle: anatomy and surgical applications. Surg Radiol Anat 2006;28:38–45. 10.1007/s00276-005-0044-1
    1. Boisrenoult P, Bricteux S, Beaufils P, et al. . [Screws versus screw-plate fixation of type 2 Schatzker fractures of the lateral tibial plateau. Cadaver biomechanical study. Arthroscopy French Society]. Rev Chir Orthopédique Réparatrice Appar Mot 2000;86:707–11.
    1. Kidiyoor B, Kilaru P, Rachakonda KR, et al. . Clinical outcomes in periarticular knee fractures with flexible fixation using far cortical locking screws in locking plate: a prospective study. Musculoskelet Surg 2018:1–5.
    1. Trenholm A, Landry S, McLaughlin K, et al. . Comparative Fixation of Tibial Plateau Fractures Using ??-BSM???, a Calcium Phosphate Cement, Versus Cancellous Bone Graft. J Orthop Trauma 2005;19:698–702. 10.1097/
    1. Belaid D, Vendeuvre T, Bouchoucha A, et al. . Utility of cement injection to stabilize split-depression tibial plateau fracture by minimally invasive methods: a finite element analysis. Clin Biomech 2018;56:27–35. 10.1016/j.clinbiomech.2018.05.002
    1. Kim G, Jung H-J, Lee H-J, et al. . Accuracy and reliability of length measurements on three-dimensional computed tomography using open-source OsiriX software. J Digit Imaging 2012;25:486–91. 10.1007/s10278-012-9458-6
    1. Mustonen AOT, Koivikko MP, Kiuru MJ, et al. . Postoperative MDCT of tibial plateau fractures. AJR Am J Roentgenol 2009;193:1354–60. 10.2214/AJR.08.2260
    1. Duffy JC. Modern epidemiology Kenneth J. Rothman, Little, Brown & Co, Boston, 1986. No. of pages: 358. Price: £33.90. Stat Med 1988;7:818 10.1002/sim.4780070712
    1. Gicquel T, Najihi N, Vendeuvre T, et al. . Tibial plateau fractures: reproducibility of three classifications (Schatzker, AO, Duparc) and a revised Duparc classification. Orthop Traumatol Surg Res 2013;99:805–16. 10.1016/j.otsr.2013.06.007
    1. Haller JM, O’Toole R, Graves M, et al. . How much articular displacement can be detected using fluoroscopy for tibial plateau fractures? Injury 2015;46:2243–7. 10.1016/j.injury.2015.06.043
    1. Colman M, Wright A, Gruen G, et al. . Prolonged operative time increases infection rate in tibial plateau fractures. Injury 2013;44:249–52. 10.1016/j.injury.2012.10.032
    1. Pizanis A, Garcia P, Pohlemann T, et al. . Balloon tibioplasty: a useful tool for reduction of tibial plateau depression fractures. J Orthop Trauma 2012;26:e88–93. 10.1097/BOT.0b013e31823a8dc8
    1. Panzica M, Suero EM, Omar M, et al. . Navigated reconstruction of tibial head depression fractures by inflation osteoplasty. Technol Health Care 2014;22:115–21. 10.3233/THC-130765
    1. Craiovan BS, Keshmiri A, Springorum R, et al. . [Minimally invasive treatment of depression fractures of the tibial plateau using balloon repositioning and tibioplasty: video article]. Orthopade 2014;43:930–3. 10.1007/s00132-014-3019-2
    1. Ziogas K, Tourvas E, Galanakis I, et al. . Arthroscopy assisted balloon osteoplasty of a tibia plateau depression fracture: a case report. N Am J Med Sci 2015;7:411–4. 10.4103/1947-2714.166223
    1. Mayr R, Attal R, Zwierzina M, et al. . Effect of additional fixation in tibial plateau impression fractures treated with balloon reduction and cement augmentation. Clin Biomech 2015;30:847–51. 10.1016/j.clinbiomech.2015.05.016
    1. Ollivier M, Turati M, Munier M, et al. . Balloon tibioplasty for reduction of depressed tibial plateau fractures: preliminary radiographic and clinical results. Int Orthop 2016;40:1961–6. 10.1007/s00264-015-3047-5
    1. Doria C, Balsano M, Spiga M, et al. . Tibioplasty, a new technique in the management of tibial plateau fracture: a multicentric experience review. J Orthop 2017;14:176–81. 10.1016/j.jor.2016.12.002
    1. Wang J-Q, Jiang B-J, Guo W-J, et al. . Arthroscopic-assisted balloon tibioplasty versus open reduction internal fixation (ORIF) for treatment of Schatzker II–IV tibial plateau fractures: study protocol of a randomised controlled trial. BMJ Open 2018;8:e021667 10.1136/bmjopen-2018-021667
    1. Vendeuvre T, Grunberg M, Germaneau A, et al. . Contribution of minimally invasive bone augmentation to primary stabilization of the osteosynthesis of Schatzker type II tibial plateau fractures: balloon vs bone tamp. Clin Biomech 2018;59:27–33. 10.1016/j.clinbiomech.2018.08.004

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