Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon: A Multi-centered Randomized Control Trial Using Standardized Objective and Subjective Outcome Measurement to Determine Rerupture Rate.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Operative vs non operative Treatment of acute ruptures of Achilles tendon.
研究概览
简要总结
The proposed trial is a multi-centre prospective randomized controlled trial comparing outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or with open operative tendon repair. All patients will undergo accelerated functional rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.
详细描述
Equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects through elimination of a surgical repair; reduction of cost to patients by eliminating need for surgery.
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
- 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
- •Complete mid-substance rupture of the Achilles tendon as diagnosed on clinical exam
- •Present for initial assessment and treatment with application of a plantar-flexed cast within 48 hours of their injury.
- •Referred to one of the participating orthopaedics surgeons in a timely fashion so as to allow for further treatment (operative repair or initiation of the rehabilitation protocol) within 14 days of their injury.
排除标准
- •Open Achilles injury
- •Achilles injury that is not a mid-substance tendon injury
- •Any additional injury to the ipsilateral lower extremity
- •Contraindication to surgery or anesthetic
- •(Physical or mental) that may interfere with compliance with the rehabilitation protocol
- •Any known factor for increased risk of Achilles tendon rupture (i.e. diabetes mellitus, immunosuppressive therapy including local or systemic steroids, and fluoroquinolone use).
结局指标
主要结局
Operative vs non operative Treatment of acute ruptures of Achilles tendon.
时间窗: 1 year
The primary outcome measure is Achilles tendon re-rupture rate
次要结局
- Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon(2 year)
研究者
Mark Glazebrook
Dr Mark Glazebrook, MSc,PHD, Dip Sports Med, MD FRCS(c)
Nova Scotia Health Authority