Management of Acute Ankle Sprain With Sodium Hyaluronate

NCT02091674 | Completed Phase 2

• 1 other identifier: 15882
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Sprain

Keywords

ankle sprain; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• VAS of pain on weight-bearing

  Visual analogue score for pain (0-100mm) on weight-bearing

  up to 90 days

Study Arms (1)

Hyaluronic acid

EXPERIMENTAL

All subjects administered hyaluronic acid

Device: Hyaluronic acid

Interventions

Hyaluronic acid DEVICE

Injected gel

Hyaluronic acid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Robert Petrella, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Chair

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: March 19, 2014
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 19, 2014

Record last verified: 2014-03