A Comparative study on Functional and Radiological outcome of bicolumnar vs column specific fixation of Proximal tibia fracture ( Schatzker type 5 and type 6 )

D.Sidharthan1 个研究点分布在 1 个国家入组 66 人开始时间: 2025年12月15日最近更新: 2025年12月3日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 66
试验地点: 1
主要终点: Functional outcome:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符

研究概览

简要总结

Tibial plateau fractures are significant intra-articular injuries, especially Schatzker type V and VI, often resulting from high-energy trauma. Evolving radiological classifications, such as Luo’s three-column approach using CT scans, have improved the understanding and management of these complex fractures. Emerging fixation methods include bicolumnar and column-specific plating, with each technique offering distinct biomechanical and clinical advantages

.Aim of Study

The primary aim is to compare the functional and radiological outcomes in tibial plateau fractures (Schatzker type V and VI) managed with column-specific fixation versus bicolumnar fixation.

Study Design

This research is designed as a prospective, randomized, comparative single-centre study. Adult patients with closed tibial plateau fractures (Schatzker type V and VI) requiring surgical fixation are included based on strict inclusion and exclusion criteria

Methodology

Participants are randomly assigned to either bicolumnar or column-specific fixation groups. Functional outcomes are evaluated using the Modified Rasmussen Clinical Scoring System and VAS pain scale, while radiological outcomes are assessed via the Modified Rasmussen Radiological Scoring System, CT scan, and X-ray at set follow-up intervals. The planned sample size is 66 patients, with follow-up at 2 weeks, 6 weeks, 3 months, and 6 months post-operation. Standardized surgical approaches (posteromedial and anterolateral) are detailed, and ethical procedures including informed consent are strictly followed.

Expected Outcomes

Column-specific fixation is hypothesized to yield superior functional and radiological outcomes compared to bicolumnar fixation in complex tibial plateau fractures. The study also anticipates providing comparative data on complication rates, early mobilization, pain, and time to return to normal activity.

Significance

Findings from this study are expected to guide evidence-based selection between bicolumnar and column-specific fixation, leading to improved management strategies, reduced complications, and better patient outcomes for complex tibial plateau fractures

研究设计

研究类型: 干预性
分配方式: 不适用
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

All Skeletally mature patients (more than 18 years of age) Closed tibial plateau fractures (schatzker type V and VI )planned for open reduction and internal fixation in single or two stage Patient willingness for follow up.

排除标准

Age less than 18 Paraplegia,quadriplegia and patient with terminal illness like leukemia etc Peripheral Diabetic Neuropathy Proximal Femoral Focal Deficiency Osteogenesis Imperfecta Hemimelia.