Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

Early Phase 1

• Conditions: Insertional Achilles Tendinitis
• Interventions: Drug: Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)

• Registration Number: NCT02368561
• Lead Sponsor: Meir Medical Center

Brief Summary

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.

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 Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues.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

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-16
• Last Update Submitted: 2015-02-16
• Study First Posted: 2015-02-23
• Last Update Posted: 2015-02-23
• Study Start: 2015-03
• Primary Completion: 2016-01
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyaluronic Acid Injection	Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)	Hyaluronic Acid Injection in 20 adult patients with IAT

Primary Outcome Measures

Name	Time	Method
Change in the VISA-A questionnaire score	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.

Secondary Outcome Measures

Name	Time	Method
The sonographic signs	Change in the achilles tendinosis sonographic signs during 6 months follow-up	The sonographic signs in the achilles enthesis- hypoechoic swelling, hyperemia, peritendinitis, fluid in the retrocalcaneal bursa, osseous prominence at the posterosuperior calcaneus.