Below Knee Cast versus Ankle Stirrup Brace for Severe Ankle Sprain: A Randomized Controlled Multicenter Noninferiority Trial
Not Applicable
Recruiting
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0001839
- Lead Sponsor
- Bundang CHA General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 310
Inclusion Criteria
1)from 18 year old to 65 year old age volunteer after acquiring informed consent
2)severe ankle sprain confirmed by sonography
Exclusion Criteria
1)7 or more days after injury
2)other injury(fracture, tendon injury, syndesmosis ligament injury, deltoid ligament injury)
3)diabetic neuropathic arthropathy
4)infection
5)underlying ankle disease(chronic ankle instability, osteoarthritis, recurrent ankle sprain within last 1 year, generalized ligament laxity)
6)obesity(body mass index > 30 or body weight > 100kg)
7)uncooperative patient
8)other inappropriate condition for case selection
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FAOS(foot and ankle outcome score) quality of ankle function score
- Secondary Outcome Measures
Name Time Method 100mm VAS(visual analogue scale) pain score;subjective satisfaction;period of return to daily life