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A study to evaluate the efficacy and safety of fracture treatment after using a low-intensity pulsed ultrasound stimulator (LIPUS, SMARTSOL ™) in fracture patients

A single-site, double-blind, randomized study to evaluate the efficacy and safety of fracture treatment after using a low-intensity pulsed ultrasound stimulator (LIPUS, SMARTSOL ™) in fracture patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004227
Enrollment
10
Registered
2019-08-21
Start date
2016-12-07
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Intervention Medical Device Terms of Use Stimulus intensity: frequency 1.5 MHz, 0.75 MHz, intensity 30, 40, 60 mW / cm 2 Application time: 20 minutes / 1 day Difference between arb
In the past, patients without fractures did not undergo any special treatment.

Sponsors

Chonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Evaluation of the formation of a bone bridge at the fracture site

Secondary

MeasureTime frame
Evaluation of the degree of bone healing by radiography

Countries

Korea, Republic of

Contacts

Public ContactSEUNG ROK KANG

Chonbuk National University Hospital

srkang@mdctc.or.kr+82-63-259-3458

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026