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Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

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.

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02368561
Enrollment
20
Registered
2015-02-23
Start date
2015-03-31
Completion date
2016-07-31
Last updated
2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insertional Achilles Tendinitis

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 Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues.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

Interventions

DRUGInjection 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

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the VISA-A questionnaire scoreChange in the VISA-A questionnaire score during 6 months follow-upThe 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

MeasureTime frameDescription
The sonographic signsChange in the achilles tendinosis sonographic signs during 6 months follow-upThe sonographic signs in the achilles enthesis- hypoechoic swelling, hyperemia, peritendinitis, fluid in the retrocalcaneal bursa, osseous prominence at the posterosuperior calcaneus.

Contacts

Primary ContactEzequiel Palmanovich, Dr
ezepalm@gmail.com972-5250868
Backup ContactOmer Slevin, Dr
Omerslevin@gmail.com972-54556306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026