Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

February 16, 2015 updated by: Meir Medical Center

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues.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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid Injection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the VISA-A questionnaire score
Time Frame: 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.
Change in the VISA-A questionnaire score during 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sonographic signs
Time Frame: 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.
Change in the achilles tendinosis sonographic signs during 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Study Director: Meir Nyska, Prop, head of orthopedic department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 16, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC140082CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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