Insertional Achilles TendinitisEarly Phase 1NCT02368561
Treatment of Insertional Achilles Tendinopathy by Hyaluronic Acid Injection
A Early Phase 1 study testing Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20) in people with Insertional Achilles Tendinitis, run by Meir Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insertional Achilles Tendinitis
- What is being tested?
- Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Insertional Achilles Tendinitis
- Being tested
- Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)Drug
US guided weekly injection of sodium hyaluronate administered for 3 week in adult subjects with insertional achilles tendinopathy
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid Injection | Experimental | Hyaluronic Acid Injection in 20 adult patients with IAT Receives: Drug: Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in the VISA-A questionnaire score during 6 months follow-up
Secondary outcomes (1)
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.
Measured: Change in the achilles tendinosis sonographic signs during 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Insertional Achilles TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meir Nyska, Prop, Study director, head of orthopedic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368561
- Sponsor's protocol ID
- MMC140082CTIL
- Status last verified
- Dec 2014
- First submitted
- 2 Feb 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24078523Wiegerinck 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.
PubMed 23052113Oshri 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.
PubMed 23738280Irwin 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.
PubMed 20964977Kearney 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.
PubMed 20727317Petrou 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.
PubMed 16388448Kumai 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.
PubMed 24817495
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02368561
- Acronym / sponsor ID
- MMC140082CTIL
- Conditions
- Insertional Achilles Tendinitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid Injection | Experimental | Drug: Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20)Hyaluronic Acid Injection in 20 adult patients with IAT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Hyaluronic Acid Injection |
Primary outcome
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.
1 secondary outcome
The sonographic signs
Time frame: Change in the achilles tendinosis sonographic signs during 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Background: PubMed 24078523Roche 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.
- Background: PubMed 23052113Wiegerinck 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.
- Background: PubMed 23738280Oshri 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.
- Background: PubMed 20964977Irwin 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.
- Background: PubMed 20727317Kearney 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.
- Background: PubMed 16388448Petrou 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.
- Background: PubMed 24817495Kumai 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meir Nyska, Prop study director
head of orthopedic department
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Injection of Hyaluronic Acid -" SYNVISC" (hylan G-F 20) in people with Insertional Achilles Tendinitis, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ezequiel Palmanovich, Dr (972-5250868, ezepalm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the VISA-A questionnaire score (time frame: Change in the VISA-A questionnaire score during 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368561, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.