Functional Improvement and UTC of the Achilles Tendon After Sodium Hyaluronate Injection for Plantaris Syndrome

March 6, 2017 updated by: Fortius Clinic

Functional Improvement and Ultrasound Tissue Characterisation of the Achilles Tendon Following Sodium Hyaluronate Injection for Plantaris Friction Syndrome

This is a study to assess the benefit of sodium hyaluronate (Ostenil) injection for plantaris friction syndrome (PFS) associated with midportion Achilles tendinopathy. Functional outcome scores will be recorded prior to treatment and at regular intervals up to 2 years. Changes in tendon structure will be assessed using ultrasonographic tissue characterisation (UTC). UTC will be performed prior to treatment and also at regular intervals up to 6 months following injection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Introduction Midportion Achilles tendinopathy is a common source of disability, with typical features including pain, swelling and dysfunction [Roche]. The causes are multifactorial [Roche]. First line treatment is typically non operative and includes an eccentric loading program [Alfredson-1998], high volume injection [Chan], platelet rich plasma [de Vos JAMA 2010], sclerosing agent injections [Alfredson-2005] , shock wave therapy [Lynen][Saxena] and for resistant cases, surgery [Alfredson-2011].

Plantaris friction syndrome (PFS) One possible cause of midportion Achilles tendinopathy is plantaris friction syndrome (PFS). In this subset of patients, the pain is located to the postero-medial aspect of the Achilles tendon. The plantaris tendon is a small vestigial tendon originating from the lateral femoral condyle, crossing obliquely to the medial side of the Achilles tendon and inserting into the medial side of the calcaneum. The anatomy at the insertion is highly variable. Over 80% of plantaris tendons insert separately to the Achilles tendon [Daseler]. Biomechanical evidence suggests that the plantaris tendon is stiffer and stronger than the Achilles tendon [Lintz]. Under load therefore, differential movement between the tendons may occur. Subsequently the plantaris tendon can become tendinopathic and thickened. Adhesions may develop between it and the adjacent Achilles tendon [Bedi], initiating medial midportion Achilles tendinopathy. Sensitization of the nerve endings in the fat layer between the Achilles and plantaris has also been demonstrated. The optimal treatment of PFS is currently unclear. Treatments include physiotherapy, injection and surgical excision [Bedi][Pearce][Weinberg][Calder-2014][Alfredson-2011].

Sodium Hyaluronate One potential treatment is injection with sodium hyaluronate which is a viscosupplement solution. It has primarily been used for joint lubrication in arthropathy, but can also be used for tendinopathy [Lynen]. Ostenil Tendon is a sodium hyaluronate solution that potentially acts in several ways to reduce pain. One mode is to act as a lubricant between tendons or between the tendon and its sheath [Akasaka 2005][Akasaka 2006][Nishida][Kumar][St Onge]. It may also promote tendon healing [Chen][Yagishta]. According to unpublished work, Ostenil Tendon significantly reduced pain at 6 weeks for peroneal and also midportion Achilles tendinopathy [Company literature]. It may also act as a medium to allow free passage of nutrients to the tendon [Hagberg]. Sodium hyaluronate injection placed in the interval between the plantaris tendon and Achilles tendon could potentially reduce friction and subsequently pain. Although the effect of sodium hyaluronate injections have been reported in the hip and knee, no previous studies have reported its efficacy for PFS. The primary aim of the current study is to assess the impact of sodium hyaluronate injections in patients with PFS.

Ultrasound tissue characterization Methods of assessing the Achilles tendon for tendinopathy continue to be debated. Common methods include ultrasound and magnetic resonance imaging [Khan][Astrom]. A novel assessment tool is ultrasound tissue characterization (UTC) which uses ultrasound to quantify tendon structure [van Schie][Docking-2015][Docking-2016][Rosengarten][Bedi].

Structural integrity of the tendon matrix is categorized in four echo types (1-green, 2-blue, 3-red, 4-black). Echo types 1 and 2 reflect aligned fibrillar structure, whereas types 3 and 4 indicate disorganised tissue [Bedi]. The entire length of the tendon can be analyzed with a minimum detectable difference in structure to be 1% [Docking-2015]. Bedi et al showed significant improvement in UTC following excision of plantaris for midportion Achilles tendinopathy [Bedi]. However this study was limited because UTC images were not performed at a uniform time pre- and post- surgery [Bedi]. Masci et al found improvement in UTC echo-structure at 6 month follow-up post plantaris excision combined with improvement in VISA-A scores [Masci]. It is debated as to whether fibrillar integrity and matrix organisation correlate with symptoms. For example, a study in elite Australian football players showed that UTC changed following pre-season training, but all players remained asymptomatic at the start and end of the study [Rosengarten]. Ultrasound studies have also questioned the relationship of tendon structure in tendinopathy and patient function [Khan][McAuliffe]. In a study of gymnasts, clinical assessment has only moderate correlation with ultrasound and MR appearances [Emerson].

Given the novelty of UTC for the Achilles tendon, the secondary aim of this study is to assess whether UTC changes following treatment for PFS and to correlate any changes with functional outcome scores.

Aims summary

  1. To determine changes in Achilles tendon matrix structure using UTC before and after treatment (6 month follow up)
  2. To assess medium term (2 years) effectiveness of a sodium hyaluronate injection in the space between the plantaris and Achilles tendons for midportion Achilles tendinopathy which is associated with PFS.
  3. To correlate UTC changes with functional scores

Hypothesis The alternate hypotheses are that sodium hyaluronate injection improves both 1) function and 2) structure of the Achilles tendon for PFS.

Outcome measures

  • Ultrasonographic tissue characterisation (UTC)
  • Functional scores - Victorian Institute of Sports Assessment-Achilles (VISA-A) [Robinson] and Foot and Ankle Outcome scores (FAOS)

Methods This will be a single centre prospective case series of patients in whom PFS has been diagnosed based upon clinical examination by a Consultant foot & ankle surgeon, physiotherapist and imaging. Patients will be prospectively followed up with pre and post intervention patient reported outcome scores.

Sample Population 33 patients diagnosed with PFS will be identified and invited to participate in the study once the decision has been made to treat with sodium hyaluronate.

Inclusion Criteria Patients aged 18-75 years Able to provide informed consent Diagnosis of PFS requiring sodium hyaluronate injection Able to follow physiotherapy instructions Exclusion Criteria Previous Achilles tendon surgery Previous injection therapy for Achilles midportion tendinopathy Age < 18 >75 years Active local infection Active bleeding disorder or anticoagulant therapy Allergies to lignocaine or sodium hyaluronate Active deep vein thrombosis

Patient Recruitment and Consent All patients will be given the information sheet regarding the study and will be consented by the CI or the Fortius foot and ankle fellow. All be patients will be recruited and treated at the Fortius Clinic.

Proposed treatment will include one or two sodium hyaluronate (Ostenil Tendon) injections. Physiotherapy is a routine part of current treatment, usually provided off site.

Injection protocol All injections will be carried out by a Consultant Radiologist at the Fortius Clinic. Approximately 3-5mm of 1% lignocaine will be injected to create a plane between Plantaris and the medial Achilles tendon. Subsequently, 2-3ml of Ostenil Tendon (sodium hyaluronate) will be injected into the space between the Achilles and plantaris tendons.

UTC assessment UTC assessment at 6 and 12 weeks is a routine part of our current treatment protocol for PFS and allows guidance of treatment. Patients will have pre and post treatment UTC assessment of the Achilles tendon. For the purposes of the study, an extra UTC assessment will be performed at 6 months, during part of their routine clinical follow up appointment. This final UTC assessment will be provided free to the patients. All UTC assessments will be conducted by the same experienced physiotherapist.

Follow up Patient reported outcome scores will be completed prior to treatment and at 6 weeks, 3 months,6 months, 1 and 2 years. Outcome scores at 1 and 2 years will be performed online via an automated email system.

UTC will be conducted at 6 weeks, 3 months and 6 months.

Ethical Issues:

Patients will be free to choose to participate or not in the study. If they choose not to participate it will not affect their treatment in any way.

No patient or volunteer will take part in the study without giving written informed consent and we will exclude those patients who are unable to give this consent.

Legal Issues:

There are no legal issues identified that will affect this study.

Management issues:

This study will take place at the Fortius Clinic, which is a private clinic. The patients included would be receiving one or two sodium hyaluronate injections, and two UTC assessments as part of the routine treatment of PFS. They will be charged for this as normal. There will be no additional charge for the final UTC assessment at 6 months.

Risks:

Patients agreeing to take part in the study will be receiving the routine treatment for PFS that they would be receiving even if the study was not taking place. There are therefore no additional risks to the patient.

Data collection All data collection will be done within the premises of the Fortius clinic by members of the clinical team, which includes a physiotherapist who works on site for the Tendon Performance Clinic. In addition to the outcome score and UTC data information regarding patient demographics, medical history and treatment will also be collected.

Data confidentiality Data will be stored in Fortius/Tendon Performance Clinic computers which are password protected and comply with information governance guidelines. No one outside the clinical team will have access to the data.

Any information that leaves the clinic will have patient identifiable information removed. All of the results will be analysed and published using anonymous data only. Details about patient's involvement in the study will also be recorded in patients' medical records held by the Fortius Clinic/Tendon Performance Clinic.

Power analysis In 18 asymptomatic elite Australian football players, UTC demonstrated improvement in Achilles tendon structure over a 5 month period following pre-season training [Docking-2016]. Bedi et al reported UTC changes following Plantaris excision and ventral paratendinous Achilles tendon scraping in athletes. In 11 patients, the fibrillar structure of the Achilles tendon improved from 90 to 96%, SD 8% p=.04. Mean VISA-A scores improved from 51 to 95, SD 12, p=.0001. Regarding sodium hyaluronate injection, only one study was found assessing its use for midportion Achilles tendinopathy [Lynen]. Lynen et al compared two paratendinous injections with three ESWT treatments given at weekly intervals in 62 patients. No previous studies have assessed its use for PFS.

Considering the limited evidence available, we estimate the sample size required to demonstrate improvements in UTC (assuming change in type 1 and 2 echo types from 90% to 96%, SD 8%) to be at least 28 patients. With an expected drop out rate of 15%, we plan to recruit 33 patients to the study.

Statistical analysis Analyses will be conducted using a statistical package. A paired t test will be used to compare pre and post treatment VISA-A scores. UTC results will be compared using Wilcoxon signed rank test (non parametric data). A p value of 0.05 will be defined as statistically significant.

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • United Kingdom
      • London, United Kingdom, W1H 6EQ
        • Recruiting
        • Fortius Clinic
        • Contact:
        • Principal Investigator:
          • James DF Calder, MD FRCS
      • London, United Kingdom

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18-75 years
  • Able to provide informed consent
  • Diagnosis of PFS requiring sodium hyaluronate injection
  • Able to follow physiotherapy instructions

Exclusion Criteria:

  • Previous Achilles tendon surgery
  • Previous injection therapy for Achilles midportion tendinopathy
  • Age < 18 >75 years
  • Active local infection
  • Active bleeding disorder or anticoagulant therapy
  • Allergies to lignocaine or sodium hyaluronate
  • Active deep vein thrombosis

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: Treatment arm
Patients with confirmed plantaris friction syndrome will be offered hyaluronic acid injection into the space between the Plantaris and Achilles tendons
Drug: Hyaluronic Acid
Ultrasound guided injection for plantaris friction syndrome
Other Names:
  • Ostenil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound Tissue Characterisation (UTC)
Time Frame: up to 6 months post intervention
Structural assessment of the Achilles tendon using ultrasound
up to 6 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot and Ankle Outcome Score (FAOS) Functional outcome
Time Frame: up to 2 years post intervention
Validated patient questionnaire to assess pain, quality of life and activities of daily living. To be competed via email or on site when attending clinical appointments
up to 2 years post intervention
Victorian Institute of Sports Assessment-Achilles (VISA-A)
Time Frame: up to 2 years post intervention
Validated patient questionnaire to measure disability caused by Achilles tendon symptoms. To be competed via email or on site when attending clinical appointments
up to 2 years post intervention

Collaborators and Investigators

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

Sponsor

Fortius Clinic

Investigators

  • Principal Investigator: James Calder, MD FRCS, Fortius Clinic, London

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 (Anticipated)

March 20, 2017

Primary Completion (Anticipated)

March 20, 2020

Study Completion (Anticipated)

March 20, 2020

Study Registration Dates

First Submitted

February 12, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FortiusClinic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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