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临床试验/NCT02368561
NCT02368561Unknown早期 1 期

A Pilot Study of the Effects of 3 Retro-calcaneal Hyalin G-F 20 Injection on the Clinical and Radiological Changes in 20 Adult Patients With Changes in Insertional Achilles Tendinopathy.

Meir Medical Center0 个研究点目标入组 20 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
20
主要终点
Change in the VISA-A questionnaire score

研究概览

简要总结

A pilot study of the effects of 3 retro-calcaneal hyalin G-F 20 injection on the clinical and radiological changes in 20 adult patients with changes in insertional achilles tendinopathy.

详细描述

Pain of the achilles tendon commonly affects young active patients, with lifetime incidence that may be as high as 40 to 50 percent in competitive athletes. About 20% of the achilles tendinopathy injuries occur in the insertion point of the achilles tendon into the calcaneus bone1. The leading theories for the mechanism of the disorder are inflammatory response or mechanical tendon overuse. Still, the exact pathogenesis of Insertional Achilles tendinitis (IAT) is unclear, and as so the conservative management of IAT is less successful than the management of the Non-insertional tendinopathy. Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues. The achilles tendon, in those studies, was almost intact. The histological features of the cartilage tissue were advanced degenerative changes, which resemble the pathologic changes of Osteoarthritis. This observation encourages to try treating IAT with management strategies that showed to be beneficial in OA( OsteoArthritis). One of the more acceptable non-surgical methods in treating osteoarthritis is intra-articular viscosupplementation injection. The investigators hypothesis, based on the histopathological finding, is that viscosupplementation may be a therapeutic option also for individuals with IAT. The purpose of this study is to show the impact of Hyalin G-F 20 injection in patients with Insertional Achilles tendinitis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Adult patients with chronic (>6 months) posterior heel pain localized above the insertion point of the achilles tendon with evidence of IAT in ankle X-RAY and MRI.

排除标准

  • Previous surgical treatment.
  • Previous HA(Hyaluronic Acid), PRP (Platelet Rich Plasma) or steroids injection in the last 6 months.
  • Previous two or more steroids injection.
  • Plantaris muscle injury.
  • Posterior ankle impingement.
  • Achilles tendon rapture.
  • Previous calcaneal fracture

研究组 & 干预措施

Hyaluronic Acid Injection

Experimental

Hyaluronic Acid Injection in 20 adult patients with IAT

干预措施: Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20) (Drug)

结局指标

主要结局

Change in the VISA-A questionnaire score

时间窗: Change in the VISA-A questionnaire score during 6 months follow-up

The VISA-A questionnaire score at 3 points during the follow-up: before the treatment, one month after the procedure and 6 months from the procedure.

次要结局

  • The sonographic signs(Change in the achilles tendinosis sonographic signs during 6 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

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