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

NCT03077009 | Unknown Phase 4 FDA Drug

• 1 other identifier: FortiusClinic
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Plantaris Friction Syndrome; Non-Insertional Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Ultrasound Tissue Characterisation (UTC)

  Structural assessment of the Achilles tendon using ultrasound

  up to 6 months post intervention

Secondary Outcomes (2)

• Foot and Ankle Outcome Score (FAOS) Functional outcome

  up to 2 years post intervention

• Victorian Institute of Sports Assessment-Achilles (VISA-A)

  up to 2 years post intervention

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients with confirmed plantaris friction syndrome will be offered hyaluronic acid injection into the space between the Plantaris and Achilles tendons

Drug: Hyaluronic Acid

Interventions

Hyaluronic Acid DRUG

Ultrasound guided injection for plantaris friction syndrome

Also known as: Ostenil

Treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fortius Clinic: lead

Study Sites (2)

Fortius Clinic

London, W1H 6EQ, United Kingdom

RECRUITING

Fortius Clinic

London, United Kingdom

RECRUITING

Related Publications (31)

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  RESULT

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• James Calder, MD FRCS

  Fortius Clinic, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Jones, MSc

CONTACT

44 (0) 203 195 2341; mary.jones@fortiusclinic.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: March 10, 2017
• Study Start: March 20, 2017
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: March 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)