A Prospective Randomized Multi Center Study to Compare Open Reduction, TightRope Fixation (OT) Versus Open Reduction Screw Fixation (OS) of the Tibia - Fibular Syndesmosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- anatomic reduction between the two groups using CT scan and plain radiographs.
研究概览
简要总结
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments.
The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed using either open or closed reduction, combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than 40%; therefore, open reduction will be performed in this study. Screw fixation is stable but concerns exist regarding potential excess rigidity.
Recently, flexible fixation techniques combined with anatomic reduction have demonstrated improvements in functional outcomes and reduction quality. Both open reduction and flexible TightRope fixation have considerable support in the literature in cohort studies but have not been compared to open screw fixation in a randomized controlled trial.
In this multi centre randomized study, radiographic, economic and functional outcomes are compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open reduction screw fixation (OS)] of the syndesmosis.
详细描述
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed using either open or closed reduction, combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than 40%; therefore, open reduction will be performed in this study. Screw fixation is stable but concerns exist regarding potential excess rigidity.
Recently, flexible fixation techniques combined with anatomic reduction have demonstrated improvements in functional outcomes and reduction quality. Both open reduction and flexible TightRope fixation have considerable support in the literature in cohort studies but have not been compared to open screw fixation in a randomized controlled trial.
This study is a multi centre randomized controlled trial comparing clinical, economic and functional outcomes between open reduction, flexible Tightrope syndesmosis fixation (OT) to open reduction rigid screw fixation (OS) for syndesmotic injuries in high ankle fractures, involving the fibula 1 cm above the level of the syndesmosis (Weber C (OTA 44.C1, 44.C2, 44C3)).
We anticipate recruiting 72 patients (36 in each arm) from up to 20 clinical sites across North America. Post operative follow up will occur at 2 and 6 weeks, 3, 6, and 12 months. At each follow up, radiographic and functional outcomes will be assessed as well as documentation of costs associated with treatment and rehabilitation.
The research questions that this study will answer include the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18yrs with a diagnosis of a closed Weber C ankle (OTA 44.C1, 44.C2, 44.C3) fracture.
- •Randomization and treatment of syndesmosis injury within 14 days of the date of injury.
- •Demonstrates lateral subluxation of talus on x-ray or stress views. Talar shift > 1mm or medial clear space widening ≥ 5mm (unstable)
- •No history of previous severe ankle injury, pathologic fracture, ligamentous laxity, no prior diagnosis or current treatment of osteoporosis or metabolic bone disease.
- •No concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
- •No neuromuscular or sensory deficiency.
- •Able to understand and complete assessments
- •Provision of Informed Consent
- •Exclusion Criteria
- •Age < 18 years
- •Open fracture or pathological fracture.
- •Talar shift < 1mm or medial clear space widening < 5mm (stable)
- •Prior diagnosis or current treatment for osteoporosis or metabolic bone disease.
- •Concurrent injury that is deemed by the treating surgeon to delay or alter the rehabilitation protocol for the ankle injury.
- •Prior diagnosis or treatment for neuromuscular disease or sensory deficiency (i.e. diabetic neuropathy).
- •Likely problems, in the judgment of the investigator, with maintaining follow-up (i.e. patients with no fixed address, patients incapable of providing informed consent, prisoners etc.).
- •Patients who are currently pregnant or planning to become pregnant during the study duration.
排除标准
- 未提供
研究组 & 干预措施
Open Reduction Tightrope fixation (OT)
Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)
干预措施: Open reduction Tightrope fixation (Device)
Open Reduction screw fixation (OS)
Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)
干预措施: open reduction screw fixation (Device)
结局指标
主要结局
anatomic reduction between the two groups using CT scan and plain radiographs.
时间窗: 3 months
anatomic reduction between the two groups using CT scan and plain radiographs
次要结局
- functional performance(6 weeks, 3,6 12 months)
- post-operative pain(6 weeks, 3, 6, 12 months)
研究者
David Sanders
Md, FRCSC
Lawson Health Research Institute