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
- 1
- 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).
研究组 & 干预措施
non-operative
cast applied within 48 hours
干预措施: non-operative (Procedure)
operative
cast applied within 48 hours and surgery within 14 days
干预措施: operative (Procedure)
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