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

Ankle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431560
• Other study ID #: National Police Hospital
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2011
• Last updated: September 8, 2011
• Start date: June 2008
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: National Police Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone

Intervention

Device:
• fixation of the ankle fracture (Solco )
fixation with metallic implant
• fixation of the ankle fracture (Freedom)
fixation with biodegradable implant

Locations

Country	Name	City	State
Korea, Republic of	National Police Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Police Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopaedic Foot and Ankle Society(AOFAS) score	change from baseline(3 months after surgery)	3 months, 6 months, 1 year	Yes
Secondary	Short Musculoskeletal Functional Assessment(SMFA) scale	change from baseline (3 months after surgery)	3 months, 6 months, 1 year	Yes