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Completed

NCT Number: NCT02198768

Ankle Fracture vs Ankle Fracture-Dislocation

The purpose of this study is to compare outcomes of patients with an ankle fracture to those with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for patients sustaining ankle fracture dislocations are poorer than those without dislocation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Carolinas Medical Center- Main

Charlotte, North Carolina, 28204, United States

About this study

Orthopaedic literature has very limited data regarding outcomes following ankle fracture dislocations. Increased knowledge of the long-term consequences of these injuries could usher in changes to treatment paradigms, potentially resulting in improved outcomes. Thirty patients will be enrolled into two arms of this prospective study: isolated ankle fractures and ankle fracture dislocations. Patients will be followed through their operative and postoperative course and clinical and radiographic assessments will be analyzed. We plan to compare the clinical, radiographic, and functional outcomes of patients with ankle fractures to those with ankle fracture-dislocations. We also plan to identify factors that contribute to or predict poor clinical, functional, and/or radiographic outcomes in patients with ankle fractures and fracture-dislocations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who sustain an isolated bi-malleolar or trimalleolar ankle fracture or an ankle fracture-dislocation requiring open reduction internal fixation
  • Patients ages 18 and over
  • The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
  • Open and closed fractures (excluding Gustilo grade 3)
  • English must be patient's primary language

Exclusion criteria

  • Previous injury or significant osteoarthritis to the affected ankle
  • Current ipsilateral or contralateral lower extremity injury with the exception of a contralateral ankle fracture or fracture-dislocation
  • Retained hardware from a previous injury at or around the tibia-talar joint of the affected extremity
  • Patients under the age of 18
  • History of inflammatory arthropathy
  • Traumatic Brain Injury or Spinal Cord Injury preventing weightbearing on the lower extremities
  • The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements
  • Patients with Gustilo grade 3B and 3C open fractures

Treatment and study plan

Primary outcomes

  1. Change in Functional Outcome

    Time frame: 6, 12, and 24 months

    Clinical and functional outcomes will be measured using the Foot and Ankle Ability Measure (FAAM) and the Short Form Musculoskeletal Functional Assessment (SMFA).

    Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.

Secondary outcomes

  1. Radiographic Outcome

    Time frame: 24 month

    Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.

Other outcomes

  1. Additional surgical procedures

    Time frame: 2 years

    Documentation of any additional surgical procedures conducted on the affected ankle. Any surgical procedure will be noted. These may include debridement for infection or dehiscence, revision for hardware failure, arthroscopy, ankle arthrodesis, or cartilage restoration procedures.

  2. Postoperative Complications

    Time frame: 2 years

    Postoperative complications will be documented and analyzed to determine if there are significant differences between the two groups. These will include infection requiring antibiotics or debridement, hardware failure, nerve or vascular injury, deep venous thrombosis, or revision surgery.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jul 24, 2014
Registry last updated
Apr 25, 2022

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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