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

NCT ID: NCT01431560

Last Updated: 2011-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ankle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metallic implant

fixation of the ankle fracture with metallic implants

Group Type ACTIVE_COMPARATOR

fixation of the ankle fracture (Solco )

Intervention Type DEVICE

fixation with metallic implant

biodegradable implant

fixation of the ankle fracture with Freedom plate and screws

Group Type ACTIVE_COMPARATOR

fixation of the ankle fracture (Freedom)

Intervention Type DEVICE

fixation with biodegradable implant

Interventions

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fixation of the ankle fracture (Solco )

fixation with metallic implant

Intervention Type DEVICE

fixation of the ankle fracture (Freedom)

fixation with biodegradable implant

Intervention Type DEVICE

Other Intervention Names

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metallic implant: Solco biodegradable implant: Freedom

Eligibility Criteria

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Inclusion Criteria

* skeletally mature subjects (≥16 years old) with unilateral ankle fractures

Exclusion Criteria

* subjects less than 16 years old,
* subjects not followed up at this hospital,
* multiple injuries,
* bilateral ankle fractures,
* open fractures,
* pathologic fractures,
* concomitant tibial shaft fractures,
* previous history of immobilization due to significant injury or a fracture of either ankle,
* significant peripheral neuropathy,
* soft tissue infection in the region on either injured ankle,
* or inability to complete the study protocol
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Police Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jung Ho Noh

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung Ho Noh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Police Hospital, Korea, Republic of

Locations

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National Police Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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National Police Hospital

Identifier Type: -

Identifier Source: org_study_id

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