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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01431560
Other study ID # National Police Hospital
Secondary ID
Status Completed
Phase Phase 4
First received September 2, 2011
Last updated September 8, 2011
Start date June 2008
Est. completion date August 2011

Study information

Verified date September 2011
Source National Police Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

The purposes of this study are to compare the outcomes of the biodegradable implants for the fixation of ankle fracture and those of metallic implants, and to assess the problems of the biodegradable implants. Null hypothesis is that the clinical outcomes of biodegradable plate and screws for ankle fracture are not different from those of metallic implants.


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
fixation of the ankle fracture (Solco )
fixation with metallic implant
fixation of the ankle fracture (Freedom)
fixation with biodegradable implant

Locations

Country Name City State
Korea, Republic of National Police Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
National Police Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary American Orthopaedic Foot and Ankle Society(AOFAS) score change from baseline(3 months after surgery) 3 months, 6 months, 1 year Yes
Secondary Short Musculoskeletal Functional Assessment(SMFA) scale change from baseline (3 months after surgery) 3 months, 6 months, 1 year Yes
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