Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection

Insertional Achilles Tendinitis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02368561
• Other study ID #: MMC140082CTIL
• Status: Not yet recruiting
• Phase: Phase 0
• First received: February 2, 2015
• Last updated: February 16, 2015
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2014
• Source: Meir Medical Center
• Contact: Ezequiel Palmanovich, Dr
• Phone: 972-5250868
• Email: ezepalm[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel : Clalit Health Organization Meir Medical center - Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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 Previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insertional Achilles Tendinitis
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

References & Publications (7)

Irwin TA. Current concepts review: insertional achilles tendinopathy. Foot Ankle Int. 2010 Oct;31(10):933-9. doi: 10.3113/FAI.2010.0933. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in the VISA-A questionnaire score during 6 months follow-up	No
Secondary	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.	Change in the achilles tendinosis sonographic signs during 6 months follow-up	No