Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Re-operation
研究概览
简要总结
Simple displaced olecranon fractures are most often treated with tension band wiring. This is an effective treatment, but the risk of subsequent re-operation is high. The investigators propose open reduction and internal fixation with a strong suture, thus reducing the risk of re-operation significantly.
详细描述
Background Olecranon fractures are frequent with an incidence of 11.5 per 100.000 people per year. Olecranon fractures are classified according to the Mayo classification in three groups. Type 1A and B are treated conservatively, while comminute fractures of type Mayo 2B and 3B are treated with plate osteosynthesis.
The most common type is a simple two part fracture, Mayo type 2A, which represents 74% of all olecranon fractures. The typical treatment of Mayo type 2A fractures is osteosynthesis using k-wires and tension band wiring. This provides adequate fracture healing and good functional results. The use of plate osteosynthesis for Mayo type 2A fractures does not provide functional or health economic benefits compared with operation with tension band wiring.
Common for both techniques is a high risk of re-operation due to delayed healing of the surgical wound, and complications arising from the implanted material.
Recently, new techniques for Mayo type 2A fractures have been described, in which no metal is implanted. Osteosynthesis is achieved with strong sutures. These techniques have been shown to reduce the high risk of complications leading to re-operation without effecting the functional outcome or fracture healing rate.
Hypothesis The investigators hypothesize that suture fixation of Mayo type 2A fractures will decrease the risk of re-operation and provide equal functional outcome compared with tension band wiring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
An envelope deciding the treatment modality is drawn while the patient is anesthetized. Post operative follow-up is performed by blinded assessors. The treatment will be revealed after one year, or if the patient is excluded from the study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Olecranon fracture, Mayo Type 2A
排除标准
- •Bilateral upper extremity fracture
- •Open fracture
- •Neurovascular affection
- •Injury to ligament, dislocation or subluxation
- •Additional upper extremity fracture
- •Pathological fracture
- •Previous elbow issue
- •Fracture more than 14 days old
- •Substance abuse
- •medical contraindication for surgery
- •Previous fracture to the same elbow
结局指标
主要结局
Re-operation
时间窗: 1 year
The rate of re-operation
次要结局
- Range of motion(1 year)
- Rate of complications(1 year)
- Sick days(1 year)
- The Disabilities of the Arm, Shoulder and Hand (DASH) Score(1 year)
- European Quality of life - 5 Dimensions (EQ-5D) questionnaire(1 year)
- Non-union(6 months)
研究者
Andreas Haubjerg Qvist
MD, Principal investigator
Aalborg University Hospital