Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
1 other identifier
interventional
109
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
September 9, 2011
CompletedSeptember 9, 2011
September 1, 2011
1.6 years
September 2, 2011
September 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American Orthopaedic Foot and Ankle Society(AOFAS) score
change from baseline(3 months after surgery)
3 months, 6 months, 1 year
Secondary Outcomes (1)
Short Musculoskeletal Functional Assessment(SMFA) scale
3 months, 6 months, 1 year
Study Arms (2)
metallic implant
ACTIVE COMPARATORfixation of the ankle fracture with metallic implants
biodegradable implant
ACTIVE COMPARATORfixation of the ankle fracture with Freedom plate and screws
Interventions
fixation with metallic implant
fixation with biodegradable implant
Eligibility Criteria
You may qualify if:
- skeletally mature subjects (≥16 years old) with unilateral ankle fractures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Police Hospital
Seoul, 138-708, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung Ho Noh, M.D., Ph.D.
National Police Hospital, Korea, Republic of
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic Surgeon
Study Record Dates
First Submitted
September 2, 2011
First Posted
September 9, 2011
Study Start
June 1, 2008
Primary Completion
January 1, 2010
Study Completion
August 1, 2011
Last Updated
September 9, 2011
Record last verified: 2011-09