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临床试验/NCT02422004
NCT02422004Unknown不适用

Healing of Human Achilles Tendon Rupture: Loading Pattern After Surgical Repair to Achieve Optimal Mechanical Properties and Clinical Outcome

Bispebjerg Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
试验地点
2
主要终点
Tendon elongation

研究概览

简要总结

The overall aim of this project is to investigate the healing processes of human tendon after suturing a ruptured Achilles tendon, and more specifically to determine the optimal loading pattern of the tendon during the rehabilitation period to ensure complete and good recovery of tendon structure and function. The investigators hypothesize that restricting early weight bearing and only allowing for passive stretching in the early phase of tendon healing will ensure better tissue regeneration and thereby prevent chronic tendon elongation and improve tendon tissue recovery and the clinical outcome.

详细描述

Surgical repair of Achilles tendon ruptures is known to significantly reduce the risk of re-rupture and to accelerate the time to return to activity compared with non-surgical treatments (1, 2). Although sutured, Achilles tendon rupture requires an extended rehabilitation period following surgery to function normally again. However, the currently available information on this post-operative treatment suggest that the currently available rehabilitation guidelines, which includes early weight bearing, does not accomplish optimal recovery of muscle-tendon function. It has been demonstrated that reduced capacity to perform heel-rises, diminished range of motion of the ankle joint, and reduced calf muscle mass is correlated with a delay in return to activity, and all of these factors could be related to elongation of the healing tendon (3). Importantly, it appears that preventing tendon elongation during rehabilitation improves the clinical outcome, but the actual mechanism for the elongation and thus how to prevent it remains unknown (4). With newly developed techniques in our laboratory we will determine the mechanical properties of human whole Achilles tendon, in vivo, which makes it possible to explore how tendons respond to the regimes following a suture repair and rehabilitation regime.

In contrast to the current rehabilitation regime after tendon surgery, which includes early high loading (weight bearing) already in the first weeks after surgery, we hypothesize that avoiding early weight bearing but allowing for early passive ankle joint range of motion (tissue strain with minimal loading) will prevent chronic tendon elongation, increase tendon stiffness, increase calf strength and muscle volume/thickness, and thus improve the long-term clinical outcome after tendon rupture in humans.

Patients with acute Achilles tendon ruptures will undergo a standardized suture repair (a.m. Kessler) using resorbable suture (Vicryl size 1) at Bispebjerg Hospital and be placed in a brace that inhibits ankle joint movement. During surgery, patients will get four tantalum beads with a diameter of 1.0 mm implanted with a venflon needle in the proximal and the distal stub of the tendon. Thereafter they will be randomized to three post-operative treatment regimes:

Control, range of motion or immobilized

From the currently available data (4, 5, 6) it is suggested that the brace is worn for 6 weeks after surgery in all three groups of the present experiment. The control group will be allowed partial weight-bearing from day 0 and full weight-bearing from week 4, toe rises after 16 weeks, jogging after 24 weeks and return to sports 34 weeks after. The two delayed weight-bearing groups (range motion group and immobilized group) will be restricted completely from weight-bearing initially (6 weeks), allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks.

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 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
  • Presented within 14 days from injury

排除标准

  • re-rupture
  • other injuries affecting their lower limb functions
  • systemic diseases influencing tendon healing
  • immunosuppressive treatment including systemic corticosteroid treatment
  • inability to follow rehabilitation or follow-ups.

结局指标

主要结局

Tendon elongation

时间窗: 2, 6, 12, 26 and 52 weeks after rupture

Tendon elongation will be evaluated using x-ray and measurements of the distance between tantalum beads

次要结局

  • Range of motion test(26 and 52 weeks after rupture)
  • Plantar flexion muscle strength(26 and 52 weeks after rupture)
  • Calf muscle size(6, 26 and 52 weeks after rupture)
  • Achilles tendon total rupture score (ATRS)(12, 26 and 52 weeks after rupture)
  • Tendon size(6, 26 and 52 weeks after rupture)
  • Heel-rise(26 and 52 weeks after rupture)
  • Elastic modulus of the tendon(6, 26 and 52 weeks after rupture)
  • Victorian Institute of Sport Assessment questionnaire - Achilles tendinopathy (VISA-A)(12, 26 and 52 weeks after rupture)

研究者

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

Pernilla Eliasson

Postdoc

Bispebjerg Hospital

研究点 (2)

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