Ankle Fracture vs Ankle Fracture-Dislocation

N/ACompletedNCT02198768

Wake Forest University Health Sciences80 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ankle Fractures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Carolinas Medical Center- Main

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Change in Functional Outcome

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.

Time frame: 6, 12, and 24 months

Secondary Outcomes

Radiographic Outcome

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.

Time frame: 24 month

Data from ClinicalTrials.gov

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