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Management of Acute Ankle Sprain With Sodium Hyaluronate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02091674
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : March 19, 2014
Information provided by (Responsible Party):
Rob Petrella, Lawson Health Research Institute

Brief Summary:

To determine the efficacy and safety of hyaluronic acid (AdantTM, Tedec-Meiji Farma SA) for acute ankle sprain, a single-site, open-label, controlled trial will be conducted.

The study will be conducted in a sport-medicine clinical research center in London, Ontario, Canada. The eligible patients will be 18 years of age and older, have first or second degree lateral sprain within 48h of the start of the treatment, and moderate or severe pain (>45mm on 100 mm pain visual analogue scale /VAS). Exclusion criteria will include bilateral ankle sprain, ipsilateral knee trauma, prior sprain in the past 6 months, use of NSAID prior to entry, intra-articular ankle injection in the prior 6 months.

The patients will receive standard care (RICE and rescue analgesics), and a single 2.5cc Adant periarticular ankle injection following provision of informed consent and collection of baseline data. NSAIDs, corticosteroids or topical analgesics will not be allowed.

Assessments will be done at baseline, days 8, 30 and day 90. Efficacy measures will include patient's pain VAS on weight bearing (0-100mm) and walking 20m (0-100mm), patients' global assessment of ankle injury (5 point categorical scale), patients' assessment of normal function/activity (5 point categorical scale), physician's global assessment of ankle injury (5 point categorical scale), patients/physician satisfaction assessment (10 point categorical scale), time to return to pain-free and disability-free sport and adverse events as per WHO definition.

It is expected that the Hyaluronic acid injections will decrease pain and swelling, promote healing, improve time to return to sport and increase mobility.

Condition or disease Intervention/treatment Phase
Ankle Sprain Device: Hyaluronic acid Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Acute Ankle Sprain With Sodium Hyaluronate (AdantTM) Periarticular Injections
Study Start Date : August 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hyaluronic acid
All subjects administered hyaluronic acid
Device: Hyaluronic acid
Injected gel

Primary Outcome Measures :
  1. VAS of pain on weight-bearing [ Time Frame: up to 90 days ]
    Visual analogue score for pain (0-100mm) on weight-bearing

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • • 18 years and older

    • first or second degree lateral ankle sprain within 48 h of administration of study drug
    • reported moderate (45 - 60 mm) to severe (>60 mm) ankle pain on full weight bearing on the Patient's Assessment of Ankle Pain using a 100 mm VAS
    • available for the duration of the study (90 days)

Exclusion Criteria:

  • • Bilateral ankle sprain

    • Ipsilateral knee injury
    • Third-degree sprain
    • Previous ankle sprain within 6 months
    • Patients who had recently used anti-inflammatory medications, muscle relaxants psychotropic medications that could confound the results
    • Patients with a history of severe GI, renal, or hepatic disease
    • Patients with rheumatic diseases
    • History of drug or alcohol abuse
    • Pregnant or lactating, or a woman of childbearing potential not willing to use an acceptable method of contraception during the study
    • Having received investigational product within 30 days of the Day 1 visit

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 identifier (NCT number): NCT02091674

Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Robert Petrella, MD, PhD Lawson Health Research Institute

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Responsible Party: Rob Petrella, Research Chair, Lawson Health Research Institute Identifier: NCT02091674     History of Changes
Other Study ID Numbers: 15882
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Keywords provided by Rob Petrella, Lawson Health Research Institute:
ankle sprain
hyaluronic acid
Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents