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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung Ho Noh, National Police Hospital
ClinicalTrials.gov Identifier:
NCT01431560
First received: September 2, 2011
Last updated: September 8, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Ankle Fracture
 Device: fixation of the ankle fracture (Solco )
Device: fixation of the ankle fracture (Freedom)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes of Operative Treatment of Unstable Ankle Fracture - Comparison Between Metallic and Biodegradable Implants

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by National Police Hospital:

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


Secondary Outcome Measures:
  • Short Musculoskeletal Functional Assessment(SMFA) scale [ Time Frame: 3 months, 6 months, 1 year ] [ Designated as safety issue: Yes ]
    change from baseline (3 months after surgery)


Enrollment: 109
Study Start Date: June 2008
Study Completion Date: August 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jung Ho Noh, Orthopaedic Surgeon, National Police Hospital
ClinicalTrials.gov Identifier: NCT01431560     History of Changes
Other Study ID Numbers: National Police Hospital
Study First Received: September 2, 2011
Last Updated: September 8, 2011
Health Authority: Korea: Institutional Review Board
United States: Federal Government

Keywords provided by National Police Hospital:
ankle
metallic
biodegradable
Freedom

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013