Management of Acute Ankle Sprain With Sodium Hyaluronate
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|ClinicalTrials.gov Identifier: NCT02091674|
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : March 19, 2014
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Hyaluronic acid
All subjects administered hyaluronic acid
Device: Hyaluronic acid
- VAS of pain on weight-bearing [ Time Frame: up to 90 days ]Visual analogue score for pain (0-100mm) on weight-bearing
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): NCT02091674
|Principal Investigator:||Robert Petrella, MD, PhD||Lawson Health Research Institute|