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
About this trial
This is an interventional treatment trial for Insertional Achilles Tendinitis
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
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
NCT ID
NCT02368561
First Posted
February 2, 2015
Last Updated
February 16, 2015
Sponsor
Meir Medical Center
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
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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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