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

September 8, 2011 updated by: Jung Ho Noh, National Police Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: metallic implant
fixation of the ankle fracture with metallic implants
Device: fixation of the ankle fracture (Solco )
fixation with metallic implant
Other Names:
  • metallic implant: Solco
Active Comparator: biodegradable implant
fixation of the ankle fracture with Freedom plate and screws
Device: fixation of the ankle fracture (Freedom)
fixation with biodegradable implant
Other Names:
  • biodegradable implant: Freedom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopaedic Foot and Ankle Society(AOFAS) score
Time Frame: 3 months, 6 months, 1 year
change from baseline(3 months after surgery)
3 months, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Musculoskeletal Functional Assessment(SMFA) scale
Time Frame: 3 months, 6 months, 1 year
change from baseline (3 months after surgery)
3 months, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Police Hospital

Investigators

  • Principal Investigator: Jung Ho Noh, M.D., Ph.D., National Police Hospital, Korea, Republic of

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 9, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2011

Last Update Submitted That Met QC Criteria

September 8, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • National Police Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on fixation of the ankle fracture (Solco )

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