An Early Phase 1 interventional study of Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20) in Insertional Achilles Tendinitis, sponsored by Meir Medical Center. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-02-23.
Sponsored by Meir Medical Center · Early Phase 1, Interventional, and Treatment
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.
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 Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues.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.
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.
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Exclusion Criteria:
Hyaluronic Acid Injection in 20 adult patients with IAT
Drug: 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
Change in the VISA-A questionnaire score
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.
Time frame: Change in the VISA-A questionnaire score during 6 months follow-up
The sonographic signs
The sonographic signs in the achilles enthesis- hypoechoic swelling, hyperemia, peritendinitis, fluid in the retrocalcaneal bursa, osseous prominence at the posterosuperior calcaneus.
Time frame: Change in the achilles tendinosis sonographic signs during 6 months follow-up
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Meir Medical Center