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

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ClinicalTrials.gov Identifier: NCT03077009
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Fortius Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Plantaris Friction Syndrome Non-Insertional Achilles Tendinopathy Drug: Hyaluronic Acid Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Improvement and Ultrasound Tissue Characterisation of the Achilles Tendon Following Sodium Hyaluronate Injection for Plantaris Friction Syndrome
Estimated Study Start Date : March 20, 2017
Estimated Primary Completion Date : March 20, 2020
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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 Name: Ostenil




Primary Outcome Measures :
  1. Ultrasound Tissue Characterisation (UTC) [ Time Frame: up to 6 months post intervention ]
    Structural assessment of the Achilles tendon using ultrasound


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077009


Contacts
Contact: Mary Jones, MSc 44 (0) 203 195 2341 mary.jones@fortiusclinic.com

Locations
United Kingdom
Fortius Clinic Recruiting
London, United Kingdom, W1H 6EQ
Contact: Joanna M Stephen, PhD    020 3195 2442    jo.stephen@fortiusclinic.com   
Principal Investigator: James DF Calder, MD FRCS         
Fortius Clinic Recruiting
London, United Kingdom
Contact: Mary Jones    44 (0) 203 195 2341    mary.jones@fortiusclinic.com   
Sponsors and Collaborators
Fortius Clinic
Investigators
Principal Investigator: James Calder, MD FRCS Fortius Clinic, London

Publications of Results:
Daseler EH, Anson BJ. The Plantaris muscle an anatomical study of 750 specimens. J Bone Joint Surg [Am] 1943;25-A:822-827.

Other Publications:

Responsible Party: Fortius Clinic
ClinicalTrials.gov Identifier: NCT03077009     History of Changes
Other Study ID Numbers: FortiusClinic
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Muscular Diseases
Tendon Injuries
Syndrome
Tendinopathy
Disease
Pathologic Processes
Musculoskeletal Diseases
Wounds and Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents