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).

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.

The occlusion balloon reduction technique for de novo placement and salvage of malpositioned enteric tubes.

PURPOSE: Nasoenteric, gastrojejunostomy, and jejunostomy tubes are methods of enteral nutrition in patients with functioning gastrointestinal tracts who cannot maintain adequate oral intake. Current placements; however, may be complicated by redundant wire and catheter loops within the stomach preventing operators from optimal feeding tube placement and predisposing patients to feeding tube prolapse. This report describes the occlusion balloon reduction technique for salvage of malpositioned tubes and placement of new enteric tubes in the setting of redundant loops. MATERIALS AND METHODS: Five patients underwent the occlusion balloon reduction technique for jejunostomy (n = 3), gastrojejunostomy (n = 1), or nasojejunal tube placement (n = 1). All patients (n = 5) had redundant wires coiled within the stomach. In all patients (n = 5), a 9-French × 32 mm × 120 cm Coda balloon was inserted over the wire and passed into the small bowel. The balloon was inflated after which reduction of redundancy in the upper gastrointestinal tract was performed. Feeding tubes were then placed with tips in the distal jejunum. Technical success of the occlusion balloon reduction technique, successful placement of enteric tube, complications, and follow-up were recorded. RESULTS: The occlusion balloon reduction was technically successful in all patients (n = 5). Feeding tube placement was successful in all patients (n = 5). No minor or major complication occurred. Mean follow-up was 56 days. CONCLUSION: The occlusion balloon reduction technique provides a method for reduction of redundant wire and catheter loops within the stomach during enteric tube placement or repositioning.

Stentoplasty of calcaneal fractures: Surgical technique and early outcomes.

Calcaneus is the most common site of hindfoot fracture, frequently caused by fall from height or high energy trauma. The therapeutic strategy ranged from non-operative to ORIF (Open Reduction Internal Fixation). Indications for percutaneous fixation include soft tissue damage or relative contraindications to open surgery. Minimally invasive percutaneous calcaneoplasty should be an alternative to ORIF aiming to reach a stable reduction, early functional recovery and short hospital stay. The aim of our study was to evaluate the clinical and radiographic outcomes of calcaneus fractures treated with balloon calcaneoplasty (BCP) by using a new generation vertebral augmentation system, VBS™-Vertebral Body Stent-DePuy Synthes. A total of 10 patients treated with VBS™ system were recruited for the study. Nine fractures were caused by a fall from height and one case by traffic accident. The mean follow-up was 8.9 months (range 2.6-23.1). The fractures were categorized according to Sanders and Essex-Lopresti classifications (5: type II, 3: type III and 2: type IV; 9: "joint depression" type and 1 case "tongue" type). Radiographic measurement (Böhler's and Gissane's angles) were evaluated at both pre-operative and immediate postoperative time. The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score as well as a subjective evaluation (Visual Analog Scale, VAS) were used for the clinical assessment at the last follow-up. Mean preoperative Böhler's angle was 12.3 ± 8.41° (95% CI 6.3-18.3°), whereas mean preoperative Gissane's angle was 123.66 ± 20.47° (95% CI 109.0-138.3°). At postoperative follow-up mean Böhler's angle increased to 21.51 ± 4.17° (95% CI 18.5-24.5°; p < 0.01), and mean postoperative Gissane's angle was 121.74°±6.82° (95% CI 116.8°-126.6°). Mean AOFAS at the last follow-up was 70.4 ± 17.44 (95% CI 57.9-82.8). Our study demonstrates that percutaneous calcaneoplasty using VBS™ is an effective treatment for calcaneus fracture and capable to implement correction manoeuvre with clinical and radiographic outcomes comparable with other percutaneous stentoplasty.