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临床试验/NCT00489749
NCT00489749已完成不适用

The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon

University of Alberta2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Health related quality of life: Short form 36 questionnaire

研究概览

简要总结

The purpose of this study was to determine the effect of protected early weightbearing (PEWB) compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on health related quality of life (HRQL) in the initial six week period after surgery, functional recovery over time, return to work and activity and complications. We hypothesized that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work and sport, and iv) no increase in complications, such as re-rupture compared to NWB.

详细描述

Achilles tendon rupture (ATR) is commonly treated with open surgical repair. Following surgical repair, there are a variety of protocols, ranging from complete immobilization to immediate postoperative mobilization with early weightbearing. However, no clear consensus regarding the optimal postoperative rehabilitation protocol for ATRs exists. Early rehabilitation after ATR has been shown to be beneficial in animal and human studies. Human prospective studies and randomized controlled trials have shown that early postoperative mobilization do not pose additional risks compared to cast immobilization, with a trend toward a reduction in lost work days and an earlier return to sport. However, these trials define early postoperative mobilization differently (i.e. use different combinations of weightbearing and range of motion). This makes it difficult to determine which factor in the early rehabilitation process plays an important role in optimizing recovery. An important component of early rehabilitation is weightbearing.

Comparison: Patients weightbearing in the early rehabilitation period after surgical repair of the Achilles tendon compared to patients non-weightbearing after the surgical repair of the Achilles tendon repair. With the exception of weightbearing status, both groups performed the same rehabilitation program.

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
Single

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • closed and complete Achilles tendon rupture
  • seen within 14 days of injury in hospital

排除标准

  • unwilling to follow the study's rehabilitation protocol
  • unable to speak or read English
  • co-morbid conditions such as diabetes and neurological or collagen disease
  • pregnancy
  • recent immunosuppressant or fluoroquinolone therapy
  • previous Achilles tendon symptoms
  • previous ipsilateral rupture
  • sustained an additional injury not allowing weightbearing
  • an Achilles tendon avulsion injury
  • unfit for surgery

结局指标

主要结局

Health related quality of life: Short form 36 questionnaire

时间窗: six weeks

次要结局

  • Health related quality of life: Short Form-36 questionnaire(3 and 6 months)
  • Level of activity: tailored question(six weeks, 3 months, and 6 months)
  • Major complications: chart review(6 weeks, 3 months, and 6 months)
  • Minor complications: chart review(6 weeks, 3 months, and 6 months)
  • Isometric muscle strength: hand held myometer(6 weeks, 3 months, and 6 months)
  • Muscle endurance: heel raise counting device(6 months)
  • Calf circumference: standardized tape measurement(6 weeks, 3 months, and 6 months)
  • Return to work/sport: tailored question(6 weeks, 3 months, and 6 months)
  • Physiotherapy utilization: tailored question(6 weeks, 3 months, and 6 months)

研究者

申办方类型
Other

研究点 (2)

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