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Management of Acute Ankle Sprain With Sodium Hyaluronate

NCT02091674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-03-19

No results posted yet for this study

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.

Conditions

  • Ankle Sprain

Interventions

DEVICE

Hyaluronic acid

Injected gel

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Robert Petrella, MD, PhD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-03-31
Completion
2014-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091674 on ClinicalTrials.gov