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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02050698
Other study ID # IRB2014-OS01
Secondary ID
Status Recruiting
Phase N/A
First received January 29, 2014
Last updated October 11, 2015
Start date January 2014
Est. completion date January 2017

Study information

Verified date October 2015
Source Hallym University Kangnam Sacred Heart Hospital
Contact Hyong Nyun Kim, MD, PhD
Phone +82-2-829-5165
Email hyongnyun@naver.com
Is FDA regulated No
Health authority Korea: Institutional Review BoardKorea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Fifth metatarsal avulsion fractures are common and can usually be treated conservatively. Symptomatic care consisting of protected weightbearing in a hard-soled shoe, air-cast walking boot, or below-knee walking cast have been successful. Several papers reported that early rehabilitation may decrease ankle stiffness, muscle and bone atrophy, and aids in early return to activities. However, early motion of the ankle joint may have the risk of displacement of the fifth metatarsal avulsion fractures. However, studies using hard-sole shoe for protected weightbearing and allowing motion of the ankle joint had successful results. Clapper et al. compared the results of hard-soled shoe and walking cast for a fifth metatarsal avulsion fracture and reported that all avulsion fractures healed uneventfully and that the results were similar between the two. However, this was not a randomized controlled trial.

Devices such as air-cast walking boot, plaster slipper, or Jone's dressing can also be used for the treatment. However, we decided to compare results of hard-soled shoe and short leg walking cast for the treatment of a fifth metatarsal avulsion fracture.

We hypothesized that the 100mm visual analogue scale (VAS) assessed on 6 months after a fifth metatarsal avulsion fracture treated with protected weightbearing in a hard-soled shoe is not inferior to protected weightbearing in a short leg walking cast but is superior to short leg walking cast with respect to time to return to normal daily life and patient's satisfaction.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Protected weightbearing in a hard-soled shoe
Patients allocated to experiment group are allowed tolerable weightbearing in a hard-soled shoe after one week of immobilization in a posterior splint
Protected weightbearing in a short leg walking cast
Patients allocated to control group are allowed tolerable weightbearing in a short leg walking cast after one week of immobilization in a posterior splint

Locations

Country Name City State
Korea, Republic of Sanbon Hospital, Wonkwang University College of Medicine Gunpo Gyeongi
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam Gyeongi
Korea, Republic of Kangnam Sacred Heart Hospital, Hallym University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary 100mm visual analogue scale (VAS) The 100mm VAS is widely used self assessment tool for evaluating pain after fracture. 6 months after a fifth metatarsal avulsion fracture No
Secondary Time to return to preinjury activity upto 6 months No
Secondary patients' subjective satisfactions 3, 5, 8, 12 weeks and 6 months after injury No
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