Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

Clalit Health Services

Status and phase: Unknown; Early Phase 1

Conditions: Insertional Achilles Tendinitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02368561

MMC140082CTIL

Details and patient eligibility

About

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.

Full description

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 Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues.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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hyaluronic Acid Injection

Experimental group

Description:

Hyaluronic Acid Injection in 20 adult patients with IAT

Treatment:

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