Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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 Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues.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.

Conditions

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Insertional Achilles Tendinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyaluronic Acid Injection

Hyaluronic Acid Injection in 20 adult patients with IAT

Group Type EXPERIMENTAL

Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)

Intervention Type DRUG

US guided weekly injection of sodium hyaluronate administered for 3 week in adult subjects with insertional achilles tendinopathy

Interventions

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Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)

US guided weekly injection of sodium hyaluronate administered for 3 week in adult subjects with insertional achilles tendinopathy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No