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Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants

NCT01431560 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2011-09-09

No results posted yet for this study

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.

Conditions

  • Ankle Fracture

Interventions

DEVICE

fixation of the ankle fracture (Solco )

fixation with metallic implant

DEVICE

fixation of the ankle fracture (Freedom)

fixation with biodegradable implant

Sponsors & Collaborators

  • National Police Hospital

    lead OTHER_GOV

Principal Investigators

  • Jung Ho Noh, M.D., Ph.D. · National Police Hospital, Korea, Republic of

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-01-31
Completion
2011-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431560 on ClinicalTrials.gov