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

Primary Purpose

Ankle Fracture

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fixation of the ankle fracture (Solco )
fixation of the ankle fracture (Freedom)
Sponsored by
National Police Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fracture focused on measuring ankle, metallic, biodegradable, Freedom

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Police Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

metallic implant

biodegradable implant

Arm Description

fixation of the ankle fracture with metallic implants

fixation of the ankle fracture with Freedom plate and screws

Outcomes

Primary Outcome Measures

American Orthopaedic Foot and Ankle Society(AOFAS) score
change from baseline(3 months after surgery)

Secondary Outcome Measures

Short Musculoskeletal Functional Assessment(SMFA) scale
change from baseline (3 months after surgery)

Full Information

First Posted
September 2, 2011
Last Updated
September 8, 2011
Sponsor
National Police Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01431560
Brief Title
Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
Official Title
Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Police Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture
Keywords
ankle, metallic, biodegradable, Freedom

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metallic implant
Arm Type
Active Comparator
Arm Description
fixation of the ankle fracture with metallic implants
Arm Title
biodegradable implant
Arm Type
Active Comparator
Arm Description
fixation of the ankle fracture with Freedom plate and screws
Intervention Type
Device
Intervention Name(s)
fixation of the ankle fracture (Solco )
Other Intervention Name(s)
metallic implant: Solco
Intervention Description
fixation with metallic implant
Intervention Type
Device
Intervention Name(s)
fixation of the ankle fracture (Freedom)
Other Intervention Name(s)
biodegradable implant: Freedom
Intervention Description
fixation with biodegradable implant
Primary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society(AOFAS) score
Description
change from baseline(3 months after surgery)
Time Frame
3 months, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Short Musculoskeletal Functional Assessment(SMFA) scale
Description
change from baseline (3 months after surgery)
Time Frame
3 months, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Ho Noh, M.D., Ph.D.
Organizational Affiliation
National Police Hospital, Korea, Republic of
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Police Hospital
City
Seoul
ZIP/Postal Code
138-708
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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