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BMJ Open. 2019 Sep 3;9(8):e026962. doi: 10.1136/bmjopen-2018-026962.

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).

Author information

1
Department of Orthopaedic Surgery and Traumatology, Centre Hospitalier Universitaire de Poitiers, Poitiers, France tanguy.vendeuvre@chu-poitiers.fr.
2
Prismatics Lab, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
3
Spine and Neuromodulation Functional Unit, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
4
ABS Lab, Poitiers University, Poitiers, France.
5
Institut Pprime, Futuroscope, Poitou-Charentes, France.
6
UFR Medecine et Pharmacie, Universite de Poitiers, Poitiers, France.
7
URCEco Ile de France, AP-HP, Hôtel-Dieu Hospital, Paris, France.
8
Department of Orthopaedic Surgery and Traumatology, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
9
Department of Orthopaedic Surgery and Traumatology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France.
10
Department of Radiology, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.

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).

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