A study to evaluate the efficacy and safety of fracture treatment after using a low-intensity pulsed ultrasound stimulator (LIPUS, SMARTSOL ™) in fracture patients
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0004227
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
1) Adult men and women over 19 years of age
2) Patients who underwent internal fixation of the tibial shaft fracture
3) The person who is judged to be suitable as the subject of the screening test
4) Those who have agreed to the written explanation of the clinical trial
1) Those taking steroids
2) Those who are taking anticoagulants
3) If you are pregnant, you are breastfeeding, or you are planning your pregnancy during the test period
4) Those taking calcium channel blockers
5) Those who have evidence of thrombophlebitis or lack of vascular function
6) Those with recent alcoholism or malnutrition history
7) Those who have a smoking history of more than 1 pack / day
8) Those who are applying other clinical trial drugs or medical devices within 30 days prior to commencement of clinical trial
9) Those who do not agree with the written consent
10) A person who is judged to be unfair as a subject
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the formation of a bone bridge at the fracture site
- Secondary Outcome Measures
Name Time Method Evaluation of the degree of bone healing by radiography