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

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ClinicalTrials.gov Identifier: NCT01431560
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by (Responsible Party):
Jung Ho Noh, National Police Hospital

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.

Condition or disease Intervention/treatment Phase
Ankle Fracture Device: fixation of the ankle fracture (Solco ) Device: fixation of the ankle fracture (Freedom) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants
Study Start Date : June 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: biodegradable implant: Freedom



Primary Outcome Measures :
  1. American Orthopaedic Foot and Ankle Society(AOFAS) score [ Time Frame: 3 months, 6 months, 1 year ]
    change from baseline(3 months after surgery)


Secondary Outcome Measures :
  1. Short Musculoskeletal Functional Assessment(SMFA) scale [ Time Frame: 3 months, 6 months, 1 year ]
    change from baseline (3 months after surgery)



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431560


Locations
Korea, Republic of
National Police Hospital
Seoul, Korea, Republic of, 138-708
Sponsors and Collaborators
National Police Hospital
Investigators
Principal Investigator: Jung Ho Noh, M.D., Ph.D. National Police Hospital, Korea, Republic of

Responsible Party: Jung Ho Noh, Orthopaedic Surgeon, National Police Hospital
ClinicalTrials.gov Identifier: NCT01431560     History of Changes
Other Study ID Numbers: National Police Hospital
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 2011

Keywords provided by Jung Ho Noh, National Police Hospital:
ankle
metallic
biodegradable
Freedom

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries