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Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

Primary Purpose

Insertional Achilles Tendinitis

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insertional Achilles Tendinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hyaluronic Acid Injection

    Arm Description

    Hyaluronic Acid Injection in 20 adult patients with IAT

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    February 2, 2015
    Last Updated
    February 16, 2015
    Sponsor
    Meir Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02368561
    Brief Title
    Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meir Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insertional Achilles Tendinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hyaluronic Acid Injection
    Arm Type
    Experimental
    Arm Description
    Hyaluronic Acid Injection in 20 adult patients with IAT
    Intervention Type
    Drug
    Intervention Name(s)
    Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)
    Intervention Description
    US guided weekly injection of sodium hyaluronate administered for 3 week in adult subjects with insertional achilles tendinopathy
    Primary Outcome Measure Information:
    Title
    Change in the VISA-A questionnaire score
    Description
    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
    Secondary Outcome Measure Information:
    Title
    The sonographic signs
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Previous surgical treatment. Previous HA(Hyaluronic Acid), PRP (Platelet Rich Plasma) or steroids injection in the last 6 months. Previous two or more steroids injection. Plantaris muscle injury. Posterior ankle impingement. Achilles tendon rapture. Previous calcaneal fracture
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ezequiel Palmanovich, Dr
    Phone
    972-5250868
    Email
    ezepalm@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Omer Slevin, Dr
    Phone
    972-54556306
    Email
    Omerslevin@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meir Nyska, Prop
    Organizational Affiliation
    head of orthopedic department
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24078523
    Citation
    Roche AJ, Calder JD. Achilles tendinopathy: A review of the current concepts of treatment. Bone Joint J. 2013 Oct;95-B(10):1299-307. doi: 10.1302/0301-620X.95B10.31881.
    Results Reference
    background
    PubMed Identifier
    23052113
    Citation
    Wiegerinck JI, Kerkhoffs GM, van Sterkenburg MN, Sierevelt IN, van Dijk CN. Treatment for insertional Achilles tendinopathy: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2013 Jun;21(6):1345-55. doi: 10.1007/s00167-012-2219-8. Epub 2012 Oct 6.
    Results Reference
    background
    PubMed Identifier
    23738280
    Citation
    Oshri Y, Palmanovich E, Brin YS, Karpf R, Massarwe S, Kish B, Nyska M. Chronic insertional Achilles tendinopathy: surgical outcomes. Muscles Ligaments Tendons J. 2012 Sep 10;2(2):91-5. Print 2012 Apr.
    Results Reference
    background
    PubMed Identifier
    20964977
    Citation
    Irwin TA. Current concepts review: insertional achilles tendinopathy. Foot Ankle Int. 2010 Oct;31(10):933-9. doi: 10.3113/FAI.2010.0933. No abstract available.
    Results Reference
    background
    PubMed Identifier
    20727317
    Citation
    Kearney R, Costa ML. Insertional achilles tendinopathy management: a systematic review. Foot Ankle Int. 2010 Aug;31(8):689-94. doi: 10.3113/FAI.2010.0689.
    Results Reference
    background
    PubMed Identifier
    16388448
    Citation
    Petrou MJ. Re: Kuipers H, Ruijsch van Dugteren G. Letter to the editors - the prohibited list and cheating in sport. Int J Sports Med 2006; 27: 80 - 82. Int J Sports Med. 2006 Jan;27(1):83-4. doi: 10.1055/s-2005-873070. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24817495
    Citation
    Kumai T, Muneta T, Tsuchiya A, Shiraishi M, Ishizaki Y, Sugimoto K, Samoto N, Isomoto S, Tanaka Y, Takakura Y. The short-term effect after a single injection of high-molecular-weight hyaluronic acid in patients with enthesopathies (lateral epicondylitis, patellar tendinopathy, insertional Achilles tendinopathy, and plantar fasciitis): a preliminary study. J Orthop Sci. 2014 Jul;19(4):603-11. doi: 10.1007/s00776-014-0579-2. Epub 2014 May 10.
    Results Reference
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    Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

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