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OpenTrials
Completed

NCT Number: NCT01431560

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

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.

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Key information

Conditions

Ankle Fracture Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Police Hospital

Seoul, 138-708, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fixation of the ankle fracture (Solco )

Device

fixation with metallic implant

Other names: metallic implant: Solco

fixation of the ankle fracture (Freedom)

Device

fixation with biodegradable implant

Other names: biodegradable implant: Freedom

Primary outcomes

  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 outcomes

  1. Short Musculoskeletal Functional Assessment(SMFA) scale

    Time frame: 3 months, 6 months, 1 year

    change from baseline (3 months after surgery)

Sponsors and collaborators

Lead sponsor

National Police Hospital

Other Gov

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Sep 9, 2011
Registry last updated
Sep 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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