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)

Abstract

IntroductionFractures 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 analysisThis 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 disseminationThis 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 numberClinicaltrial.gov:NCT03444779.

Development of Digital Twins to Optimize Trauma Surgery and Postoperative Management. A Case Study Focusing on Tibial Plateau Fracture

“…Further validation including ex vivo experimentations, a retrospective and prospective analysis should be conducted before any patient-specific clinical use. A randomized, controlled, and blinded clinical study currently in progress regarding tuberoplasty will provide valuable data to evaluate the presented workflow (Vendeuvre et al, 2019).…”

“…Tibial plateau fractures represent 1.03% of all bone fractures in the general population (Elsoe et al, 2015) and 8% in the elderly population (Rozell et al, 2016). Recently, a new minimally invasive surgery (MIS) named tuberoplasty has been developed to treat the two most common types of tibial plateau fractures: Type II and Type III in the Schatzker classification (Vendeuvre et al, 2013(Vendeuvre et al, , 2019Kfuri and Schatzker, 2018) also known as Type 41-B3.1 and Type 41-B2.1 in the OTA/AO classification (Meinberg et al, 2018).…”

Magnetic Resonance Imaging Image under Low-Rank Matrix Denoising Algorithm in the Diagnosis and Evaluation of Tibial Plateau Fracture Combined with Meniscus Injury

“…e chief physician was required to perform the TPF surgery and meniscus injury detection and repair surgery [14].…”

Treatment of tibial plateau fractures: A comparison of two different operation strategies with medium-term follow up

“…However, several pitfalls of ORIF, such as excessive bone damage and soft tissue injury, high infection risk and functional rehabilitation difficulties with delayed activity and scar formation [ 7 ]. With technological advancements, many minimally invasive surgery (MIS) techniques for TPFs, such as the balloon technique, arthroscopy and bone tamp, have been performed among orthopedic surgeons [ [8] , [9] , [10] , [11] ]. However, developing an optimal method that can treat all types of TPFs, maximize improved knee function and prevent the progression of posttraumatic arthritis is difficult.…”