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临床试验/NCT01470833
NCT01470833已完成不适用

Non-operative Treatment of Acute Achilles Tendon Rupture Using Dynamic Rehabilitation. The Influence of Early Weight-bearing Compared With Non-weight-bearing

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年4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
60
试验地点
2
主要终点
ATRS (Achilles Tendon Total Rupture Score)

研究概览

简要总结

Acute achilles tendon rupture is relatively frequent (11 to 37 per 100,000). There are great social benefits in optimizing treatment and shortening recovery.

There is no consensus concerning the best treatment of acute achilles tendon rupture. Traditionally, surgical treatment is considered superior, but more recent studies show evidence that non-operative treatment with early dynamic rehabilitation gives the same functional outcome with fewer side effects.

Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not evidence based rather due to tradition. It is well documented that mechanical load improves tendon healing in general and has no detrimental effect on the healing of operated achilles tendons.

The objective of this randomized study is to compare early weight-bearing with non-weight-bearing following non-operative treatment of acutely ruptured Achilles tendons.

详细描述

Background Acute achilles tendon rupture is relatively frequent (11 to 37 per 100,000) and potentially debilitating. Age distribution is bimodal, with a maximum incidence of sports-related injuries around 40 years of age. This is followed by a second and smaller increase in the incidence 50-60 years of age due to other, non sports-related injuries (1-3). The disease costs millions of dollars in treatment and lost earnings.

There is no consensus on the best treatment of acute achilles tendon rupture. It is the authors' belief that the decision on non-operative or operative treatment significantly differ between the orthopedic surgical departments and individual orthopedic surgeons.

Surgery is traditionally considered superior to conservative treatment due to a lower risk of rerupture of the achilles tendon (4). Despite the fact that surgery has a significantly increased risk of serious side effects such as deep infection (4). The decision of operative treatment is based on studies comparing surgical treatment and early dynamisation with non-operative treatment without dynamisation. Recent studies show increasing evidence that non-operative treatment with early dynamisation of the ankle gives the same functional outcome as operative treatment without significantly increased risk of rerupture (5.6). The same studies show that the overall complication rate is higher with surgery than with non-operative treatment. The surgical complications include infection, nerve damage, adhesion, contracture and cosmetic problems.

Pajala et. al have compared outcome for patients who suffered rerupture with those who suffered a deep wound infection. They conclude that outcome after rerupture without complicating infection is satisfactory, whereas the outcome after deep wound infection is devastating (7). The risk of a debilitating complication is thus greater with surgery than is the case for conservative treatment.

Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not evidence based rather due to tradition. Suchak et. al have shown that early weight bearing after surgical treatment of ASR improves health related quality of life in the period after surgery and has no negative effect on tendon healing.(9) It is well documented that mechanical load improves tendon healing (10). Thus it is reasonable to believe that early loading of the tendon under controlled conditions will affect tendon healing beneficially.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 years.
  • The patient must be able to speak and understand Danish.
  • The patient must be able to give informed consent.
  • The patient should be able to follow a regimen with a removable ankle orthosis.
  • The patient must be able to determine when rupture occurred, and it can't be over 4 days old.
  • The patient should be able to follow the postoperative controls.

排除标准

  • Terminal illness.
  • Former achilles tendon rupture
  • Former surgery on the achilles tendon
  • Treatment with fluoroquinolones during the last 6 months.
  • Tendinosis treated with a tablet or injection with corticosteroids within the last 6 months.
  • Diagnosis of arterial insufficient in the leg.
  • Lack of palpable pulse in the foot
  • Severe medical illness: ASA score greater than 2
  • Distance from calcaneus to the rupture is less than 1 cm

结局指标

主要结局

ATRS (Achilles Tendon Total Rupture Score)

时间窗: 1 year

Patient-reported validated scoring tool developed for assessment of symptoms and physical activity after treatment for acute achilles tendon rupture.

次要结局

  • Heel-rise-work test(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristoffer Barfod

Medical Doctor

Hvidovre University Hospital

研究点 (2)

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